Federal and state leaders join CordenPharma to celebrate a major investment in expanding U.S.-based peptide manufacturing capacity and strengthening America’s pharmaceutical supply chain

• The expansion strengthens CordenPharma’s U.S. peptide manufacturing network, adding significant upstream peptide synthesis capacity in South Carolina to complement downstream large-scale peptide operations in Colorado.
• Together, CordenPharma’s South Carolina and Colorado facilities are expected to represent more than $1.4 billion in U.S. peptide manufacturing investment, supporting growing demand for peptide APIs used in medicines treating obesity, diabetes, cardiovascular disease, cancer, and other serious diseases.
• The project will create more than 200 high-quality U.S. jobs while strengthening domestic pharmaceutical supply chains and expanding American manufacturing capabilities for next-generation peptide therapeutics.

NORTH AUGUSTA, SOUTH CAROLINA, U.S. – September 23, 2026

CordenPharma, a leading global Contract Development and Manufacturing Organization (CDMO), today announced the groundbreaking of a major expansion project at its North Augusta, South Carolina facility. The ceremony, held on September 22, 2026, marks an important milestone in the company’s strategy to expand U.S.-based peptide manufacturing capacity and support growing global demand for peptide therapeutics.

The investment exceeds $200 million and forms part of CordenPharma’s broader commitment to expand its U.S. peptide business, which is expected to reach more than $1.4 billion in total investment across its South Carolina and Colorado operations. The project strengthens domestic production capabilities for peptide Active Pharmaceutical Ingredients (APIs), including those used in GLP-1 therapies and other innovative treatments addressing some of the world’s most significant healthcare challenges.

Dignitaries joining the celebration included South Carolina Governor Henry McMaster, Assistant Secretary of Commerce for Industry and Analysis Steven Haines and North Augusta Mayor Briton Williams, together with CordenPharma leadership, employees, media and community stakeholders.

Combined with CordenPharma’s large-scale peptide production in Colorado, the expanded South Carolina site will provide our client-partners:

• 68,000 square feet of purpose-built commercial manufacturing space supporting clinical to commercial peptide programs
• Flexible SPPS, LPPS and hybrid platforms engineered for long, complex, and high-purity peptide APIs
• Shorter lead times and accelerated tech transfer
• Dual-site flexibility and business continuity that will strengthen supply security and mitigate risk

The project is expected to create more than 200 new high-quality jobs in South Carolina while contributing to the continued growth of domestic pharmaceutical manufacturing, helping to strengthen the U.S. healthcare supply chain and support the production of critical therapies for patients worldwide.

South Carolina Governor Henry McMaster commented: “South Carolina continues to attract world-class life sciences investment because companies know they will find the talented workforce, business environment, and partnership needed to succeed. CordenPharma’s expansion in North Augusta will create high-quality jobs, strengthen our state’s thriving pharmaceutical manufacturing industry, and further establish South Carolina as a leader in advanced manufacturing and innovation.”

Assistant Secretary of Commerce for Industry and Analysis Steven Haines commented: “President Trump’s America First agenda is clear: the medicines Americans depend on should be made in America, by American workers. CordenPharma’s investment answers that call by expanding critical pharmaceutical manufacturing on American soil, creating more than 200 high-quality jobs, and reducing our dependence on foreign supply chains. This project strengthens our economic and national security and helps ensure that America continues to lead the world in advanced manufacturing.”

Paul Perreault, Chairman of the Board for CordenPharma, commented: “We are investing today for future demand of innovative breakthrough medicines. Medical professionals and patients expect and deserve our expertise to deliver the manufacturing capacity for these life-changing medicines. This expansion strengthens our ability to help customers bring the next generation of peptide medicines to market faster, reliably, and at scale, reinforcing CordenPharma’s long-term commitment to expanding advanced pharmaceutical manufacturing in the United States.”

As peptide therapeutics continue to transform the treatment landscape across multiple disease areas, CordenPharma remains committed to investing ahead of market demand and building the manufacturing infrastructure required to deliver reliable, scalable peptide supply for customers and patients worldwide.

About CordenPharma

CordenPharma is a CDMO supporting and partnering with biotech and pharma innovators of complex modalities in the advancement of their drug development lifecycle. Harnessing the collective expertise of the teams across its globally integrated facility network, CordenPharma provides bespoke outsourcing services spanning the complete supply chain, from early clinical-phase development to commercialization.

With scientific expertise and partnership at its core, CordenPharma provides customers with high-value, end-to-end services with a strategic focus on Peptides, Small Molecules (both Highly Potent and Regular Potency), customized Lipid Excipients, Lipid NanoParticles (LNPs), sterile Injectables, and Oligonucleotides

The CordenPharma Group is currently comprised of 13 facilities across Europe, North America and Asia with more than 3500 employees. In the 2025 financial year, the organization generated sales of €960 million. In 2022, CordenPharma was acquired by Astorg to accelerate its development and further strengthen its capabilities in the CDMO space.

Please visit cordenpharma.com for more information I Follow CordenPharma on LinkedIn
CordenPharma Media

CordenPharma Media Contacts North America: abby.thompson@cordenpharma.com I Europe & Asia: eva.schaub@cordenpharma.com

Inluriyo plus Verzenio delivers proven clinical benefit after the evidence-based practice of maximizing initial treatment with an aromatase inhibitor, with or without a CDK4/6 inhibitor 

In the Phase 3 EMBER-3 trial, Inluriyo in combination with Verzenio doubled median progression-free survival compared to Inluriyo alone, among patients with ESR1-mutated MBC

The all-oral combination of Inluriyo and Verzenio gives patients a treatment approach that targets the two central drivers of ER+ breast cancer, with an established tolerability profile and no new monitoring required 

INDIANAPOLIS, Sept. 2026 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Inluriyo (imlunestrant), an oral estrogen receptor (ER) antagonist, in combination with Verzenio (abemaciclib), a CDK4/6 inhibitor, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated locally advanced or metastatic breast cancer (MBC), as detected by an FDA -authorized test, with disease progression following at least one line of endocrine therapy. The approval is based on the proven clinical benefit of switching to Inluriyo in combination with Verzenio at clinical progression as observed in the Phase 3 EMBER-3 trial.

“In less than a year since its approval, Inluriyo is the leading treatment option for people with ER+, HER2–, ESR1m metastatic breast cancer, now reaching over half of all patients starting an oral SERD,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology. “Today’s full approval extends what Inluriyo in combination with Verzenio can do for patients, with a regimen that has confirmed benefit, is aligned to the clinically proven treatment paradigm of changing therapy at clinical progression, and doesn’t introduce burdensome monitoring requirements for patients or physicians. In fact, all available evidence suggests that switching endocrine therapy and CDK4/6 inhibitor at clinical progression improves patient outcomes more than switching therapy earlier. Utilizing this evidence-based practice spares early exposure to additional side effects, reduces patient anxiety from unnecessary testing, and mitigates avoidable costs to the healthcare system.”

This full FDA approval is based on the results of the Phase 3 EMBER-3 trial in patients with MBC whose tumors harbor an ESR1 mutation (n=159). Patients received Inluriyo (n=92) or Inluriyo in combination with Verzenio (n=67) after an aromatase inhibitor (AI), with or without a CDK4/6 inhibitor, in either the adjuvant or metastatic setting. Among patients with ESR1-mutated MBC, Inluriyo in combination with Verzenio doubled median progression-free survival (PFS) versus Inluriyo alone, with a median PFS of 11.1 months versus 5.5 months (HR=0.53 [95% CI, 0.35–0.80]).

“We have an urgent need for effective and safe treatment options for patients with disease progression on adjuvant or first-line therapy. Combining therapies that work on two distinct drivers of tumor growth—the estrogen receptor and CDK4/6—is an important strategy to help address treatment resistance,” said Komal Jhaveri, MD, FACP, FASCO, Associate Attending Breast Medicine and Early Drug Development Services, section head of the Endocrine Therapy Research Program at Memorial Sloan Kettering Cancer Center, and principal investigator for the EMBER-3 and EMBER-4 trials. “In EMBER-3, switching both the endocrine therapy and CDK 4/6 inhibitor, for the majority of patients, to imlunestrant plus abemaciclib at disease progression achieved a median progression-free survival of 11.1 months and a safety profile consistent with that of each medicine individually, establishing a meaningful new treatment option.”

In about half of patients with ER+, HER2– MBC, tumors develop a genetic change called an ESR1 mutation during or after treatment with a common class of hormone-blocking medicines known as AIs. These mutations can cause estrogen receptors to become overactive, fueling cancer growth. Inluriyo and Verzenio target two different drivers of tumor growth, offering a combined approach to help slow the disease. Inluriyo degrades mutated estrogen receptors, cutting off the signal that drives cancer cells to grow. Verzenio targets proteins that control how quickly cancer cells divide, helping to slow their growth.

The Inluriyo label contains a warning and precaution for embryo-fetal toxicity. See Important Safety Information below and full Prescribing Information for additional information.

The Verzenio label contains warnings and precautions for severe diarrhea, neutropenia, interstitial lung disease/pneumonitis, hepatotoxicity, venous thromboembolism, embryo-fetal toxicity, and increased serum creatinine without affecting renal function. See Important Safety Information below and full Prescribing Information for additional information.

In EMBER-3, the majority of adverse events (AEs) with Inluriyo in combination with Verzenio were Grade 1-2. The most common (≥10%) adverse reactions, including laboratory abnormalities, were decreased neutrophils, diarrhea, decreased hemoglobin, decreased lymphocytes, nausea, decreased platelets, fatigue, increased triglycerides, infections, increased AST, increased creatinine, increased ALT, vomiting, musculoskeletal pain, abdominal pain, decreased appetite, increased cholesterol, rash, cough, headache, and decreased weight. Permanent discontinuation of Inluriyo alone due to adverse reactions in the combination arm occurred in 1% of patients, and permanent discontinuation of Verzenio alone in the combination arm occurred in 3.4% of patients.

This marks the second FDA approval for Inluriyo in less than a year, following its September 2025 approval as monotherapy for the treatment of adults with ER+, HER2–, ESR1-mutated MBC whose disease progressed after at least one line of endocrine therapy (ET).

Inluriyo is also being studied in the Phase 3 EMBER-4 trial (NCT05514054) in the adjuvant setting for people with ER+, HER2– early-stage breast cancer (EBC) at increased risk of recurrence following standard of care endocrine therapy, including CDK4/6 inhibitors. EMBER-4 is the largest adjuvant oral SERD clinical trial, with more than 8,000 patients enrolled worldwide across 650+ sites in 30+ countries. Initial results are anticipated in 2027.

Inluriyo in combination with Verzenio is now available in the United States.

See Important Safety Information below and full Prescribing Information for additional information.

About Inluriyo (imlunestrant)
Inluriyo (imlunestrant) (pronounced en-loo-ree-yoh) is an oral estrogen receptor antagonist that delivers continuous ER inhibition, including in ESR1-mutant cancers. The estrogen receptor (ER) is the key therapeutic target for patients with ER+, HER2– breast cancer. Inluriyo is a U.S. FDA approved oral prescription medicine, 200 mg tablets taken as a once-daily dose of 400 mg taken on an empty stomach, at least 2 hours before food or 1 hour after food. Inluriyo is also currently being studied as an adjuvant treatment in early breast cancer in the Phase 3 EMBER-4 trial (NCT05514054).

For full details on indicated uses of Inluriyo in ER+, HER2– ESR1m metastatic breast cancer, please see full Prescribing Information, available at www.inluriyo.lilly.com.

About Verzenio^® (abemaciclib)
Verzenio (abemaciclib) is approved to treat people with certain HR+, HER2– breast cancers in the adjuvant and advanced or metastatic settings.

Verzenio is an oral tablet taken twice daily and available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers, Verzenio was first approved in 2017 and is authorized for use in more than 90 countries around the world.

For full details on indicated uses of Verzenio in HR+, HER2– breast cancer, please see full Prescribing Information, available at www.verzenio.lilly.com.

Important Safety Information for Inluriyo^® (imlunestrant) as Monotherapy and in Combination with Verzenio^® (abemaciclib)

Diarrhea: Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Instruct patients at the first sign of loose stools to initiate antidiarrheal therapy, increase oral fluids, and notify their healthcare provider. In EMBER-3, diarrhea occurred in 86% of patients who received Inluriyo in combination with Verzenio; Grade 3 or 4 diarrhea occurred in 9%. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Neutropenia: Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. In EMBER-3, neutrophil count decreased in 86% of patients who received Inluriyo in combination with Verzenio; Grade 3 or 4 decreases occurred in 21%. Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. In EMBER-3, ILD or pneumonitis occurred in 2.9% of patients who received Inluriyo in combination with Verzenio. Monitor for clinical symptoms or radiological changes indicative of ILD/pneumonitis. Permanently discontinue Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Hepatotoxicity: Increases in serum transaminase levels have been observed. Perform liver function tests (LFTs) before initiating treatment with Verzenio. Monitor LFTs every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated with Verzenio. Monitor ALT and AST during treatment with Inluriyo as clinically indicated. In EMBER-3, ALT increase occurred in 33% for all grades (Grade 3 or 4: 5%) and AST increase occurred in 36% for all grades (Grade 3 or 4: 2.5%) of patients who received Inluriyo in combination with Verzenio. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Venous Thromboembolism: Deaths due to venous thromboembolism have been reported in patients treated with Verzenio. In EMBER-3, venous thromboembolic events occurred in 4.8% of patients who received Inluriyo in combination with Verzenio. Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Embryo-Fetal Toxicity: Inluriyo and Verzenio can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to initiating treatment. Advise females of reproductive potential to use effective contraception during treatment with Inluriyo in combination with Verzenio and for 3 weeks after the last dose of Verzenio or 1 week after the last dose of Inluriyo, whichever is longer. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose of Inluriyo.

For Inluriyo monotherapy, advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Inluriyo and for 1 week after the last dose.

Increased Serum Creatinine Without Affecting Renal Function: Verzenio can increase serum creatinine. These increases were not associated with changes in glomerular function. In EMBER-3, creatinine increase occurred in 36% for all grades (Grade 3 or 4: 1.1%) of patients who received Inluriyo in combination with Verzenio. During Verzenio treatment, use alternative measures that are not based on serum creatinine to assess renal function such as BUN, cystatin C, or calculated GFR.

Serious and Fatal Adverse Reactions for Inluriyo in combination with Verzenio: Serious adverse reactions occurred in 21% of patients who received Inluriyo in combination with Verzenio. Serious adverse reactions in >1% of patients who received Inluriyo in combination with Verzenio included pneumonia (2.4%), abdominal pain, and renal failure (each 1.4%). Fatal adverse reactions occurred in 3.8% of patients who received Inluriyo in combination with Verzenio, including pneumonia (1.4%), myocardial infarction, interstitial lung disease, and sepsis (0.5% each).

Most Common Adverse Reactions for Inluriyo in combination with Verzenio: The most common (≥10%) adverse reactions with Inluriyo in combination with Verzenio, including laboratory abnormalities, were decreased neutrophils, diarrhea, decreased hemoglobin, decreased lymphocytes, nausea, decreased platelets, fatigue, increased triglycerides, infections, increased AST, increased creatinine, increased ALT, vomiting, musculoskeletal pain, abdominal pain, decreased appetite, increased cholesterol, rash, cough, headache, and decreased weight.

Serious and Fatal Adverse Reactions for Inluriyo Monotherapy: Serious adverse reactions occurred in 10% of patients who received Inluriyo. Serious adverse reactions in >1% of patients included pleural effusion (1.2%). Fatal adverse reactions occurred in 1.8% of patients who received Inluriyo, including cardiac arrest, acute myocardial infarction, right ventricular failure, hypovolemic shock, and upper gastrointestinal hemorrhage (each 0.3%).

Most Common Adverse Reactions for Inluriyo Monotherapy: The most common (≥10%) adverse reactions with Inluriyo monotherapy, including laboratory abnormalities were decreased hemoglobin, musculoskeletal pain, decreased calcium, decreased neutrophils, increased AST, fatigue, diarrhea, increased ALT, increased triglycerides, nausea, decreased platelets, constipation, increased cholesterol, and abdominal pain.

Drug Interactions – Inluriyo:

• Avoid concomitant use with strong CYP3A inhibitors. If concomitant use cannot be avoided, decrease the Inluriyo dosage. Avoid concomitant use with strong CYP3A inducers. If concomitant use cannot be avoided, increase the Inluriyo dosage. See Prescribing Information for recommended dosage modifications.
• Imlunestrant inhibits both P-gp and BCRP. Avoid concomitant use unless otherwise recommended in the Prescribing Information for P-gp or BCRP substrates where minimal concentration changes may lead to serious adverse reactions.

Drug Interactions – Verzenio:

• CYP3A Inhibitors: Avoid concomitant use of ketoconazole. Reduce the Verzenio dose with concomitant use of other strong and moderate CYP3A inhibitors. Monitor for adverse reactions and follow the specific dose modification instructions located in the Prescribing Information. Patients should avoid grapefruit products.
• CYP3A Inducers: Avoid concomitant use of strong and moderate CYP3A inducers and consider alternative agents.

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment with Inluriyo in combination with Verzenio and for 3 weeks after the last dose of Verzenio or 1 week after the last dose of Inluriyo, whichever is longer.

For Inluriyo monotherapy, advise lactating women to not breastfeed during treatment with Inluriyo and for 1 week after the last dose.

Hepatic Impairment: With Inluriyo, reduce the dose in patients with moderate or severe hepatic impairment. The recommended dosage for patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment is 200 mg once daily. No dosage modification is recommended for patients with mild hepatic impairment (Child-Pugh A).

With Verzenio, reduce the dosing frequency to once daily in patients with severe hepatic impairment (Child-Pugh C). No dosage adjustments are necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B).

Inluriyo may impair fertility in females and males of reproductive potential.

Verzenio may impair fertility in males of reproductive potential.

Inluriyo (imlunestrant) is available as 200 mg tablets.

Verzenio (abemaciclib) is available as 50 mg, 100 mg, 150 mg, and 200 mg tablets.

Please click to access full Prescribing Information for Inluriyo and Verzenio.

IN VZ HCP ISI Combo+Mono APPR

Frequently Asked Questions

1. What is Inluriyo (imlunestrant)?

Inluriyo (imlunestrant) is an FDA-approved oral estrogen receptor antagonist also described as an oral selective estrogen receptor degrader, or oral SERD. It is designed to bind to the estrogen receptor (ER) and inhibit ER-driven signaling. In September 2025, Inluriyo (imlunestrant) was FDA-approved for treatment of adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer (MBC) with disease progression following at least one line of endocrine therapy. In September 2026, Inluriyo in combination with Verzenio was approved for the treatment of adults with ER+, HER2–, ESR1-mutated advanced or MBC, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

2. What is Verzenio (abemaciclib)?

Verzenio (abemaciclib) is approved to treat people with certain HR+, HER2– breast cancers in the adjuvant and advanced or metastatic setting. Verzenio is the first CDK4/6 inhibitor approved to treat node-positive, high risk early breast cancer (EBC) patients. In high risk EBC, Verzenio has shown a persistent and deepening benefit beyond the two-year treatment period in the monarchE trial, an adjuvant study designed specifically to investigate a CDK4/6 inhibitor in a node-positive, high risk EBC population. In metastatic breast cancer, Verzenio has demonstrated statistically significant overall survival in the Phase 3 MONARCH 2 study. Verzenio has shown a consistent and generally manageable safety profile across clinical trials. 

3. What are the clinical benefits of the Inluriyo (imlunestrant) and Verzenio (abemaciclib) combination?

In an analysis of the primary outcome data, Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) doubled progression-free survival [11.1 months versus 5.5 months with Inluriyo (imlunestrant) alone (HR=0.53 [95% CI, 0.35–0.80]) in patients with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer.

4. What type of FDA approval did Inluriyo in combination with Verzenio receive?

Inluriyo in combination with Verzenio received full approval from the FDA for the treatment of adults with ER+, HER2–, ESR1-mutated advanced or MBC based on the results of the Phase 3 EMBER-3 trial. Full approval is not contingent on confirmatory trial results, distinguishing it from accelerated approval, which the FDA grants based on a surrogate endpoint likely to predict clinical benefit and requires confirmatory trials to verify that benefit.

5. Do Inluriyo (imlunestrant) or Verzenio (abemaciclib) have any black box warnings?

Neither Inluriyo or Verzenio have boxed warnings.  

6. What is metastatic or locally advanced breast cancer?

Metastatic or advanced breast cancer (MBC) is defined as breast cancer that has spread from the breast to other parts of the body. Locally advanced breast cancer has grown beyond the breast to nearby tissue or lymph nodes, but has not spread to other parts of the body.¹ Of all high risk early-stage breast cancer cases diagnosed in the U.S., approximately 30% will become metastatic² and an estimated 6-10% are metastatic at diagnosis.³ Survival is lower among patients with a more advanced disease at diagnosis.⁴ The estimated five-year survival rates for people living with breast cancer are 99% for localized disease, 86% for regional/locally advanced disease, and 30% for metastatic or advanced disease.⁴ Other factors, such as tumor size, also impact five-year survival estimates.⁴

7. Why are estrogen receptors important in treating breast cancer?

Approximately 70% of breast cancers express the estrogen receptor (ER), which is a key driver of cancer growth and a common therapeutic target. Treatments that block, degrade, or interfere with ER signaling are designed to stop the growth signal the cancer cells need to grow and divide.

8. How does Inluriyo (imlunestrant) target the estrogen receptor?

Inluriyo (imlunestrant) is an estrogen receptor (ER) antagonist that works by binding to ER, switching off signals that tell cancer cells to grow, and triggering ER to be broken down, thus slowing cancer growth. Within the oncology community, this approach is often referred to as a selective estrogen receptor degrader (SERD).

9. Why are oral SERDs important for patients with treatment-resistant ER+ breast cancer?

Up to 50% of people with ER+, HER2– metastatic breast cancer previously treated with endocrine therapy may develop an ESR1 mutation that is difficult to treat with other endocrine therapies. Inluriyo (imlunestrant) is an estrogen receptor antagonist that works by binding to ER, switching off signals that tell cancer cells to grow, and triggering ER to be broken down, thus slowing cancer growth.

10. In which Phase 3 clinical trials is Inluriyo (imlunestrant) being studied?

Inluriyo is currently being studied in two clinical trials:

• EMBER-3 (NCT04975308) is a Phase 3, randomized, open-label study of Inluriyo (imlunestrant), investigator’s choice of endocrine therapy, and Inluriyo in combination with abemaciclib in patients with ER+, HER2– locally advanced or metastatic breast cancer (MBC), as detected by an FDA-authorized test, whose disease has recurred or progressed during or following an aromatase inhibitor (AI) therapy with or without a CDK 4/6 inhibitor. More information on the EMBER-3 study can be found on clinicaltrials.gov.
• EMBER-4 (NCT05514054) is a Phase 3, randomized, open-label study of adjuvant Inluriyo (imlunestrant) versus standard adjuvant endocrine therapy in patients with ER+, HER2– early breast cancer with an increased risk of recurrence following initial endocrine therapy, with or without a CDK4/6 inhibitor. More information on the EMBER-4 study can be found on clinicaltrials.gov.

11. What makes EMBER-4 different from other adjuvant breast cancer trials?

The Phase 3 EMBER-4 trial is the largest oral SERD study, enrolling more than 8,000 patients across 650+ sites in 30+ countries. The trial is studying Inluriyo (imlunestrant) in patients with ER+, HER2– early breast cancer at increased risk of recurrence, in the adjuvant (post-surgery) setting.

EMBER-4 was designed as a sequential trial: patients were enrolled following initial standard adjuvant endocrine therapy, including patients with or without prior CDK4/6 inhibitor treatment. This design mirrors how patients are actually treated today. It asks the question: can Inluriyo (imlunestrant) provide additional protection for patients who have already received initial standard of care hormone therapy with or without a CDK4/6 inhibitor, when risk of recurrence increases.

About Breast Cancer
Breast cancer is the second most commonly diagnosed cancer worldwide (following lung cancer), according to GLOBOCAN. The estimated 2.3 million new cases indicate that close to 1 in every 4 cancers diagnosed in 2022 is breast cancer. With approximately 666,000 deaths in 2022, breast cancer is the fourth-leading cause of cancer death worldwide.⁵ In the U.S., it is estimated that there will be more than 310,000 new cases of breast cancer diagnosed in 2024. Breast cancer is the second leading cause of cancer death in women in the U.S.⁶

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We’ve been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer’s disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

CMAT-44358 09/2026

© Lilly USA, LLC 2026. ALL RIGHTS RESERVED.

MSK Disclosure: Dr. Jhaveri has financial interests related to Eli Lilly and Company.

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ^® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company’s or their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Inluriyo in combination with Verzenio as a treatment for people with certain types of breast cancer and other conditions and reflects Lilly’s current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Inluriyo plus Verzenio will receive additional regulatory approvals, or that Inluriyo plus Verzenio will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, see Lilly’s Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Endnotes & References

1. André F, et al. Ann Oncol. 2021;32(2): 208-217.
2. O’Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. Oncologist. 2005;10 Suppl 3:20-9. PMID: 16368868 DOI: 10.1634/theoncologist.10-90003-20
3. Metastatic Breast Cancer Network. 13 Facts about Metastatic Breast Cancer. http://www.mbcn.org/13-facts-about-metastatic-breast-cancer/. Accessed September 2026.
4. American Cancer Society. Breast Cancer Facts & Figures 2022-2024. Atlanta: American Cancer Society, Inc. 2022. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/2022-2024-breast-cancer-fact-figures-acs.pdf. Accessed September 2026.
5. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263.
6. American Cancer Society. Cancer Statistics Center. http://cancerstatisticscenter.cancer.org. Accessed September 2026.

Refer to:	Michelle Webb;  michelle.webb@lilly.com; 463-206-4463 (Media)
	Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors)

FAYUVI is a highly anticipated, first-ever treatment option with the potential to stop or slow the devastating, irreversible neurologic progression and loss of function associated with Sanfilippo syndrome Type A

Ultragenyx’s UltraCare® program will support access, and commercial product is expected to be available to ship to Qualified Treatment Centers within 30-60 days

FAYUVI marks the second gene therapy approval, and sixth FDA approval overall, for Ultragenyx

The Company received a Priority Review Voucher upon FAYUVI approval

NOVATO, Calif., Sept. 2026 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) announced that the U.S. Food and Drug Administration (FDA) granted standard full approval of FAYUVI™ (rebisufligene etisparvovec-hopf), also known as UX111, for the treatment of pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome Type A). FAYUVI is the first-ever FDA-approved treatment for Sanfilippo syndrome Type A, a progressive and fatal neurodegenerative disease, and the second gene therapy approval for Ultragenyx. The Company received a Priority Review Voucher upon this approval.

“The approval of FAYUVI reflects years of research from scientists and developers, as well as unwavering support from so many families and patient organizations in the face of a devastating, universally fatal disease with no treatment options. This is a historic milestone for a community that has waited far too long, but has never given up hope,” said Emil D. Kakkis, M.D., Ph.D., chief executive officer and president of Ultragenyx. “We recognize the profound urgency of making this therapy available to families, and our focus now is on supporting timely access in the U.S. as we work closely with treatment centers and payers to support families on the gene therapy treatment journey. FDA approval is an important first step toward our long-term goal to bring this treatment option to families of children with Sanfilippo syndrome Type A around the world.”

“The U.S. FDA approval of FAYUVI is a milestone that the Sanfilippo syndrome Type A community spent decades fighting to achieve: the first-ever treatment for a disease that relentlessly steals a child’s abilities, independence, and future,” said Glenn O’Neill, president and co-founder of the Cure Sanfilippo Foundation, and Terri Klein, CNPM, MPA, president and chief executive officer of the National MPS Society. “This remarkable scientific achievement is the culmination of decades of advocacy, fundraising, collaboration, and perseverance across the Sanfilippo community along with researchers, clinicians, and industry partners who never lost faith that progress was possible. We celebrate by honoring every family who contributed and remembering the children we lost while waiting for this day. Together, we look ahead with renewed hope knowing that this treatment is now approved for children and families affected by this heartbreaking disease.”

About Sanfilippo Syndrome Type A and FAYUVI
Sanfilippo syndrome Type A is an ultra-rare, fatal lysosomal storage disease that primarily affects the brain and is marked by rapid, progressive neurodegeneration beginning in early childhood. Children with Sanfilippo syndrome Type A typically experience progressive global developmental delay, followed by the loss of cognitive, language, and motor function, ultimately leading to early death. Sanfilippo syndrome Type A is estimated to affect approximately 3,000 to 5,000 patients in commercially accessible geographies, with a median life expectancy of 15 years. The disease is caused by a deficiency of the sulfamidase (SGSH) enzyme, which results in the accumulation of heparan sulfate substrate in cells and progressive damage to the central nervous system. FAYUVI is a single-dose intravenous AAV9 gene therapy designed to deliver a functional copy of the deficient enzyme gene that can express and replace the SGSH enzyme.

“This gene therapy addresses a pressing unmet clinical need and offers families a promising therapeutic option,” said Kevin M. Flanigan, M.D., director of the Center for Gene Therapy at Nationwide Children’s Hospital and principal investigator on the study that led to its approval. “It is additionally gratifying in that this vector was first developed at Nationwide Children’s more than a decade ago, and its approval highlights our commitment to developing therapies that meaningfully impact children’s health.”

The final delivery of this therapy did not come without tremendous difficulties during its development, and the Company hopes this approval will revitalize the investment in other ultra-rare gene therapies. The therapy was developed by Haiyan Fu, PhD, and Doug McCarty, PhD, during their tenures at Ohio State University/Nationwide Children’s Hospital and was licensed to Abeona. When funding constraints arose despite positive clinical data, Abeona made the pivotal decision to out-license the asset to Ultragenyx, ensuring this vital treatment reached the finish line for patients. Ultragenyx thanks the researchers, the development and leadership team at Abeona, and so many families, patient advocacy groups, and investigators who worked tirelessly through so many obstacles over the many years to lead the Company to this moment of shared success.

Clinical Program Supporting FAYUVI
The approval of FAYUVI is supported by data from the pivotal Transpher A trial and long-term follow-up studies, which demonstrated clinical benefit relative to the decline observed in natural history, along with durable treatment effect across clinical assessments and multiple biomarkers while maintaining an acceptable safety profile. Clinical data now extend to up to nearly 8 years of follow-up.

Biochemical efficacy in replacing the missing enzyme was demonstrated by a reduction in accumulated cerebral spinal fluid (CSF) heparan sulfate (HS) levels throughout the study and across all age groups. Clinical efficacy was assessed based on patients’ mean change in Bayley-III Cognitive raw score from 24 to 60 months of age. FAYUVI-treated patients from the modified intention-to-treat (mITT) population (N=17) were compared to untreated patients with Sanfilippo syndrome Type A from an external, comparable natural history cohort (N=27). FAYUVI-treated patients (mITT) demonstrated a 23.5 point higher (p<0.0001) cognitive score over natural history during the period of study, providing the efficacy basis for standard full approval.

Enabling Access for Eligible Patients
Ultragenyx will provide support to help enrolled patients and caregivers navigate access to treatment through its UltraCare^® program, which now includes specially trained UltraCare^® Gene Therapy Guides to help understand insurance coverage, assist in obtaining treatment support, and answer questions about the treatment process. Dedicated in-house UltraCare Gene Therapy Guides are available Monday through Friday from 9 a.m. to 8 p.m. Eastern Time at 888-756-8657. More information is available at www.ultracaresupport.com. 

FAYUVI will be available through a network of Qualified Treatment Centers (QTCs), which are U.S.-based healthcare institutions with specialized expertise and training to administer gene therapy. Ultragenyx expects commercial product will be available for shipment to QTCs within 30-60 days.

FAYUVI is manufactured entirely within the U.S., at Ultragenyx’s Gene Therapy Manufacturing Facility in Bedford, Massachusetts, and Andelyn Biosciences in Columbus, Ohio.

Additional details, including information on the QTC network, will be available on fayuvi.com, which is expected to be live within the coming days.

Investor Conference Call
Ultragenyx will host a conference call today at 5:30 p.m. Eastern Time/2:30 p.m. Pacific Time to discuss the FAYUVI approval. The live and replayed webcast of the call will be available through the company’s website at https://ir.ultragenyx.com/events-presentations.

INDICATION
FAYUVI™ (rebisufligene etisparvovec-hopf) is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of neurologic manifestations of mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome type A) in pediatric patients with preserved neurodevelopmental function.’

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hepatotoxicity
Elevated liver enzymes (ALT, AST, and GGT) were observed in clinical studies of FAYUVI. Prior to FAYUVI infusion, assess liver function by clinical examination and laboratory testing (ALT, AST, GGT, and total bilirubin), and evaluate liver-related medical history. Administer corticosteroids to all patients before and after the FAYUVI infusion. If abnormalities are observed, adjust the corticosteroid treatment regimen, including increasing the dose and/or prolonging the corticosteroid taper period.

Closely monitor ALT, AST, GGT, and total bilirubin levels after FAYUVI administration until 2 weeks after the corticosteroid taper is complete and as clinically indicated. Continue to monitor liver function in all patients who develop elevated liver enzymes until levels return to baseline. 

Thrombocytopenia
Decreased platelet counts were observed in clinical studies of FAYUVI.
Prior to FAYUVI infusion, assess platelet counts. Monitor platelet counts weekly for the first 4 weeks, then monthly for 6 months following infusion. Continue monitoring as clinically indicated.

Thrombotic Microangiopathy
Thrombotic microangiopathy (TMA) has been reported in association with AAV gene therapies. While there have been no cases of TMA associated with FAYUVI in clinical studies, laboratory and clinical monitoring for TMA following FAYUVI infusion is recommended.

Monitor platelet counts closely within the first 4 weeks following FAYUVI infusion. Signs and symptoms of TMA may include, but are not limited to, thrombocytopenia, hemolytic anemia, easy bruising, hypertension, seizures, decreased urine output, and renal dysfunction. If TMA is suspected, immediately consult a pediatric hematologist and/or nephrologist for further evaluation and management as clinically indicated.

Hypersensitivity and Infusion Reactions
Infusion reactions, including hypersensitivity reactions and anaphylaxis, may occur with infusion of FAYUVI. Symptoms may include, but are not limited to, hypotension, pyrexia, palpitation, nausea, vomiting, chills, or headache.

Closely monitor patients for clinical signs and symptoms of infusion reactions, including hypersensitivity reactions, and monitor vital signs during and after completion of FAYUVI infusion as clinically indicated. In the event of an infusion reaction during administration, pause the infusion and provide supportive care according to clinical practice. If the infusion is paused and continued administration is appropriate, restart at a slower rate after the infusion reaction has resolved.

Risk of Malignancy
Malignancy may occur following treatment with FAYUVI due to potential integration of AAV vector DNA into the genome. 

In the event of a malignancy, contact Ultragenyx Pharmaceutical Inc. at
1-888-756-8657.

ADVERSE REACTIONS
The most common adverse reactions are (≥5%): liver enzyme increased (85%), vomiting (67%), abnormal behavior (56%), diarrhea (48%), pyrexia (41%), white cell count decreased (30%), Cushingoid features (30%), decreased appetite (22%), platelet count decreased (19%), anemia (19%), constipation (15%), nausea (11%), amylase increased (11%), alkaline phosphatase increase (11%), seizure (11%), hepatomegaly (11%), muscle spasticity (7%), hypokalemia (7%), gait disturbance (7%), and adrenal insufficiency (7%).

VACCINATIONS
Prior to FAYUVI administration, consider the patient’s vaccination status. Vaccines should be avoided 30 days prior to treatment with FAYUVI (and use of corticosteroids) and while on corticosteroid therapy.

PREGNANCY
There are no data on the use of FAYUVI in pregnant women.  Women who are pregnant or desire to become pregnant should not be treated with FAYUVI. A negative serum pregnancy test must be confirmed before administration of FAYUVI in females of childbearing potential.

VECTOR SHEDDING
Temporary vector shedding of FAYUVI occurs primarily through bodily fluids and waste. Advise patients and/or caregivers on proper handling of patient bodily fluids and waste, including hand hygiene after direct contact. These precautions should be followed for 3 months after FAYUVI infusion.

Report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Ultragenyx Pharmaceutical Inc. at 1-888-756-8657.
Please see the full Prescribing Information for FAYUVI.

About Ultragenyx
Ultragenyx is a biopharmaceutical company committed to bringing novel therapies to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved medicines and treatment candidates aimed at addressing diseases with high unmet medical need and clear biology, for which there are typically no approved therapies treating the underlying disease.

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.

For more information on Ultragenyx, please visit the company’s website at: www.ultragenyx.com.

Forward-Looking Statements and Use of Digital Media
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the commercial launch, availability, timing of shipment and market acceptance of FAYUVI; Ultragenyx’s ability to supply FAYUVI to Qualified Treatment Centers; patient access to FAYUVI, including insurance coverage and reimbursement; the safety, efficacy, durability and potential benefits of FAYUVI; the potential commercial opportunity for FAYUVI; and Ultragenyx’s ability to satisfy FDA requirements and maintain approval for FAYUVI, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.

Such forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks and uncertainties related to the commercial launch and market acceptance of FAYUVI; the ability to identify eligible patients and establish and support a network of Qualified Treatment Centers; uncertainty related to insurance coverage and reimbursement; risks related to serious or undesirable side effects, including risks associated with AAV gene therapy; manufacturing risks and the ability to manufacture and supply FAYUVI in sufficient quantities and in compliance with regulatory requirements; the risk that the FDA may modify the approved indication, impose additional requirements or withdraw approval if applicable requirements are not satisfied; smaller than anticipated market opportunities; competition from other therapies or products; product liability; regulatory scrutiny; and other matters that could affect the availability or commercial potential of Ultragenyx’s products and product candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements.

For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Ultragenyx in general, see Ultragenyx’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2026, and its subsequent periodic reports filed with the SEC.

In addition to its SEC filings, press releases and public conference calls, Ultragenyx uses its investor relations website and social media outlets to publish important information about the company, including information that may be deemed material to investors, and to comply with its disclosure obligations under Regulation FD. Financial and other information about Ultragenyx is routinely posted and is accessible on Ultragenyx’s Investor Relations website (https://ir.ultragenyx.com/) and LinkedIn website (https://www.linkedin.com/company/ultragenyx-pharmaceutical-inc-/).

Ultragenyx Contacts

Investors
Joshua Higa
ir@ultragenyx.com

Media
Jess Rowlands
media@ultragenyx.com

Overture Therapeutics, headquartered in Waltham, M.A., is developing antibody medicines for obesity and cardiometabolic disease. Its lead program, OVT-109, is a potential first-in-class antibody: a selective, long-acting antagonist of an emerging GPCR whose loss-of-function protects against obesity. OVT-109 is designed to recapitulate its metabolic benefits, including reduced weight and adiposity. Overture is advancing OVT-109 toward nonhuman primate studies in Q4 2026.

Solutions

OVT-109 targets an emerging GPCR whose naturally occurring loss-of-function protects against obesity, lower body weight and reduced adiposity. This fully human antibody is designed for potent, selective, durable receptor blockade with potential for infrequent dosing.

In vivo, OVT-109 recapitulated key benefits of the protective genetic phenotype, reducing diet-induced weight gain and improving glucose homeostasis. Combined with semaglutide, OVT-109 produced 13.8% greater weight reduction and 25.9% greater fat-mass reduction compared with semaglutide alone, without significantly greater lean-mass loss or reduced food intake.

These findings support OVT-109 as a genetically validated lever of human metabolism with potential across monotherapy, combination and long-term weight management.

Strengths

• Genetic Evidence: Overture is targeting an untapped lever of human metabolism supported by compelling human genetics, with naturally occurring loss-of-function associated with a 54% lower obesity risk, lower body weight, and reduced adiposity.
• Native GPCR Discovery: Overture’s native cell-based discovery approach targets physiologically relevant receptor conformations, enabling antibody discovery against complex GPCRs without relying on engineered recombinant antigens or conventional small-molecule binding pockets.
• Translational Readiness: OVT-109 is a fully human, highly specific, and potent antagonist with native-receptor engagement, cynomolgus cross-reactivity, multi-pathway functional blockade, and in vivo metabolic activity. These characteristics support advancement into nonhuman primate studies and IND-enabling development.
• Differentiated Pipeline: Overture is expanding beyond OVT-109 through engineered antibody-peptide conjugates and fusion proteins designed to combine complementary mechanisms in single molecules and create differentiated multi-modal therapies for obesity and cardiometabolic disease.

Meet the Team

From left to right:

Russell Beckerman  | Co-founder + CEO

Patrick J. Krohl, Ph.D. | Co-founder, President + CSO

Update Supports Broader Access to IMDELLTRA in Community Settings for People Living with Extensive-Stage Small Cell Lung Cancer

THOUSAND OAKS, Calif., September 2026 /PRNewswire/ — Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) approved an update to the IMDELLTRA^® (tarlatamab-dlle) Prescribing Information that substantially reduces the recommended monitoring time for the first two doses of treatment in an appropriate healthcare setting.

This approval means that patients receiving IMDELLTRA should now be monitored for 6 to 8 hours from the start of their first two infusions, compared with the previously recommended 22 to 24 hours. Patients will also receive a follow-up assessment, including vital signs, the day after each of these first two doses.

For people living with extensive-stage small cell lung cancer (ES-SCLC), the change could mean substantially less time spent in a healthcare setting during the initial treatment period. The updated requirement may also reduce treatment complexity for community oncology practices, where an estimated 80% to 85% of U.S. cancer patients receive care.¹

“People being treated for small cell lung cancer are already navigating an aggressive and difficult-to-treat disease, and the time required to receive and monitor treatment can add to that burden for both patients and care centers,” said Jay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data at Amgen. “This approval is an important step in simplifying care for people living with and treating ES-SCLC. Reducing monitoring to 6-8 hours for the initial doses may help address practical barriers associated with administering IMDELLTRA and enable more patients to receive care closer to home. We continue to work closely with the healthcare community to ensure appropriate educational support for navigating IMDELLTRA treatment is available to providers, patients and care partners.”

“In community oncology, we care for patients where they live, and for people living with small cell lung cancer, that matters,” said David M. Waterhouse, MD, MPH, FASCO, medical oncologist/hematologist at Oncology Hematology Care in Cincinnati, OH. “These patients are often very sick, and traveling long distances or spending extended time in a healthcare setting can be difficult for them and their families. Reducing the required monitoring period may make IMDELLTRA more feasible to administer in community practices, helping more patients receive treatment in their local care network and spend less time away from their support systems.”

ES-SCLC is an aggressive form of lung cancer in which most patients experience disease progression following first-line treatment.² The scope of the label update was limited to the first two doses, which now recommends only 6 to 8 hours of monitoring from the start of infusion in an appropriate healthcare setting. Beyond the update to the first two doses and the addition of a patient assessment following those initial doses, the monitoring and supportive care recommendations remain unchanged: 6-8 hours of monitoring following the third dose (Cycle 1 Day 15) and throughout Cycle 2, decreasing to 3-4 hours for Cycles 3-4 and 2 hours for Cycle 5 and subsequent doses. It is recommended that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. Patients will also receive a follow-up assessment, including vital signs, the day after each of these first two doses on Cycle 1, Days 2 and 9.

The updated monitoring requirements represent an important evolution in the administration of IMDELLTRA and reinforce Amgen’s commitment to advancing treatments while addressing the real-world needs of people living with cancer.

Amgen recently announced landmark positive topline overall survival data from the Phase 3 DeLLphi-305 study in first-line ES-SCLC. Reduced post-infusion monitoring timing is being evaluated in several ongoing studies across indications and lines of therapy which will continue to inform the potential to further reduce monitoring approaches in the future.

About Small Cell Lung Cancer (SCLC)
SCLC is one of the most aggressive and devastating forms of solid tumor cancer. Each year, SCLC accounts for approximately 13-15% of more than 2.6 million cases of lung cancer diagnosed worldwide.^2-4 Despite initial high response rates to first-line platinum-based chemotherapy, most patients quickly relapse within months and require subsequent treatment options.² 

About IMDELLTRA^® (tarlatamab-dlle)
IMDELLTRA is a first-in-class targeted immunotherapy engineered by Amgen researchers to bind to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.^5,6 DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.^7,8

U.S. INDICATION
IMDELLTRA^® (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

• Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA^®. Initiate IMDELLTRA^® using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA^® until CRS resolves or permanently discontinue based on severity.
• Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA^®. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA^® until ICANS resolves or permanently discontinue based on severity.

WARNINGS AND PRECAUTIONS

• Cytokine Release Syndrome (CRS): IMDELLTRA^® can cause CRS including life-threatening or fatal reactions. In the pooled safety population, CRS occurred in 57% (268/473) of patients who received IMDELLTRA^®, including 39% Grade 1, 15% Grade 2, 1.7% Grade 3 and 0.2% Grade 4. Recurrent CRS occurred in 24% of IMDELLTRA^®-treated patients including 20% Grade 1 and 3.4% Grade 2; one patient experienced recurrent Grade 3.
   
  Among the 268 patients who experienced CRS, 73% had CRS after the first dose, 60% had CRS after the second dose, and 15% had CRS following the third or later dose. Following the Cycle 1 Day 1, Day 8, Day 15 infusions, 24%, 8%, and 1% of patients experienced Grade ≥ 2 CRS, respectively. From Cycle 2 onwards, 1.5% of patients experienced Grade ≥ 2 CRS. Of the patients who experienced CRS, 31% received steroids and 10% required tocilizumab. The median time to onset of all grade CRS from most recent dose of IMDELLTRA^® was 16 hours (range: start of infusion to 15 days). The median time to onset of Grade ≥ 2 CRS from most recent dose of IMDELLTRA^® was 15 hours (range: start of infusion to 15 days).
  
  Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).
  
  Administer IMDELLTRA^® following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA^® infusions as described in Table 3 of the Prescribing Information (PI) to reduce the risk of CRS. Administer IMDELLTRA^® in an appropriate healthcare facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA^®.
   
  Closely monitor patients for signs and symptoms of CRS during and after treatment with IMDELLTRA^®. At the first sign of CRS during treatment, immediately discontinue IMDELLTRA^® infusion. If CRS occurs during or after treatment, evaluate the patient for hospitalization and manage based on severity. Withhold or permanently discontinue IMDELLTRA^® based on severity. Counsel patients and caregivers to seek immediate medical attention should signs or symptoms of CRS occur after discharge.
   
• Neurologic Toxicity, Including ICANS: IMDELLTRA^® can cause life-threatening or fatal neurologic toxicity, including ICANS. In the pooled safety population, neurologic toxicity occurred in 65% of patients who received IMDELLTRA^®, with Grade 3 or higher events in 7% of patients including fatal events in 0.2%. The most frequent neurologic toxicities were dysgeusia (34%), headache (17%), peripheral neuropathy (9%), dizziness (9%), and insomnia (8%). The incidence of signs and symptoms consistent with ICANS was 10% in IMDELLTRA^®-treated patients including events with the preferred terms: ICANS (4.7%), muscular weakness (3.2%), cognitive disorder (0.6%), aphasia (0.6%), depressed level of consciousness (0.4%), seizures (0.4%), encephalopathy (0.4%), and leukoencephalopathy (0.2%). There was one fatal reaction of ICANS. Recurrent ICANS occurred in 1.5% of patients. Of the patients who experienced ICANS, most experienced the event following Cycle 1 Day 1 (2.5%) and Cycle 1 Day 8 (3.6%). Following Day 1, Day 8, and Day 15 infusions, 1.3%, 1.3% and 0.4% of patients experienced Grade ≥ 2 ICANS, respectively. ICANS can occur several weeks following administration of IMDELLTRA^®. The median time to onset of ICANS from the first dose of IMDELLTRA^® was 16 days (range: 1 to 862 days). The median time to resolution of ICANS was 4 days (range: 1 to 40 days).
   
  The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.
   
  Patients receiving IMDELLTRA^® are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until neurologic symptoms resolve.
   
  Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment with IMDELLTRA^®. At the first sign of ICANS, immediately discontinue the infusion, evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRA^® or permanently discontinue based on severity.
  
  Cytopenias: IMDELLTRA^® can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, based on laboratory data, decreased neutrophils occurred in 16% of patients, including 9% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased neutrophil count was 41 days (range: 2 to 306 days). Decreased platelets occurred in 30% including 2.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 67 days (range: 3 to 420 days). Decreased hemoglobin occurred in 56% of patients, including 4.7% Grade 3 or 4. Febrile neutropenia was reported as an adverse event in 1.5% of patients treated with IMDELLTRA^®.
   
  Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with all doses of IMDELLTRA^®, up through Cycle 5 Day 15 and then prior to administration on Day 1 of each cycle starting with Cycle 6. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue IMDELLTRA^®.
   
• Infections: IMDELLTRA^® can cause serious infections, including life-threatening and fatal infections.
   
  In the pooled safety population, infections, including opportunistic infections, occurred in 43% of patients who received IMDELLTRA^®, including 14% Grade 3 or 4. The most frequent infections were pneumonia (11%), urinary tract infection (9%), COVID-19 (6%), upper respiratory tract infection (4.7%), respiratory tract infection (4%), candida infection (2.1%), oral candidiasis (2.1%), and nasopharyngitis (2.1%).
   
  Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRA® and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRA^® based on severity.
   
• Hepatotoxicity: IMDELLTRA^® can cause hepatotoxicity. In the pooled safety population, based on laboratory data, elevated ALT occurred in 39% of patients who received IMDELLTRA^®, including 2.5% with Grade 3 or 4 ALT. Elevated AST occurred in 43% of patients, including 3.2% Grade 3 or 4. Elevated bilirubin also occurred in 16% of patients, including 1.3% Grade 3 or 4. Liver enzyme elevation can occur with or without concurrent CRS.
   
  Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRA^®, and as clinically indicated. Withhold IMDELLTRA^® or permanently discontinue based on severity.
    
• Hypersensitivity: IMDELLTRA^® can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with IMDELLTRA^® and manage as clinically indicated. Withhold or consider permanent discontinuation of IMDELLTRA^® based on severity.
   
• Embryo-Fetal Toxicity: Based on its mechanism of action, IMDELLTRA^® may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA^® and for 2 months after the last dose.

ADVERSE REACTIONS

• The pooled safety population reflects exposure to intravenous IMDELLTRA^®, as a single agent, at the recommended dosage of IMDELLTRA^® 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8 and 15, and then every 2 weeks until disease progression or intolerable toxicity in 473 patients with small cell lung cancer enrolled in three clinical trials: DeLLphi-300, DeLLphi-301 and DeLLphi-304. Among 473 patients who received IMDELLTRA^®, 40% were exposed for 6 months or longer and 19% were exposed for greater than one year.
• The most common (≥ 20%) adverse reactions were CRS (57%), fatigue (48%), decreased appetite (38%), dysgeusia (34%), pyrexia (33%), constipation (31%), musculoskeletal pain (31%), and nausea (25%).
• The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (43%), decreased sodium (12%), decreased total neutrophils (9%), and increased uric acid (6%).

DOSAGE AND ADMINISTRATION: Important Dosing Information

• Administer IMDELLTRA^® as an intravenous infusion over 1 hour.
• Administer IMDELLTRA^® according to the step-up dose in the IMDELLTRA^® PI (Table 1) to reduce the incidence and severity of CRS.
• Evaluate complete blood count, liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA^® up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA^® on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary if clinically indicated.
• For Cycle 1, administer recommended concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA^® infusions to reduce the risk of CRS reactions as described in the PI (Table 3).
• IMDELLTRA^® should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS.
• Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRA^® infusion for 6 to 8 hours following Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
• Perform patient assessment including vital signs check on Cycle 1 Days 2 and 9.
• Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA^® following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver.
• Inform both the patient and the caregiver on the signs and symptoms of CRS and ICANS prior to discharge.
• Ensure patients are well hydrated prior to administration of IMDELLTRA^®.

Please see IMDELLTRA^® full Prescribing Information, including BOXED WARNINGS.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.

More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, inflammatory conditions, rare diseases, heart disease and obesity and obesity-related conditions.

Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average^®, and it is also part of the Nasdaq-100 Index^®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads.

Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd.), the performance of Otezla^® (apremilast), our acquisitions of ChemoCentryx, Inc., Dark Blue Therapeutics, Ltd. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon’s business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

Any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

CONTACT: Amgen, Thousand Oaks
Brianna Wilkins, 513-284-9807 (media)
Casey Capparelli, 805-447-1746 (investors)

REFERENCES

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2. Oronsky B, Abrouk N, Caroen S, et al. A 2022 update on extensive stage small-cell lung cancer (SCLC). J Cancer. 2022;13(9):2945-2953. doi:10.7150/jca.75622.
3. International Agency for Research on Cancer. Trachea, bronchus and lung fact sheet. Global Cancer Observatory: Cancer Today. Published 2024. Accessed September 2, 2026. https://gco.iarc.who.int/today/en/fact-sheets-cancers/15/trachea-bronchus-and-lung.
4. Sabari JK, Lok BH, Laird JH, et al. Unravelling the biology of SCLC: implications for therapy. Nat Rev Clin Oncol. 2017;14(9):549-561. doi:10.1038/nrclinonc.2017.71.
5. Giffin MJ, Cooke K, Lobenhofer EK, et al. AMG 757, a half-life extended, DLL3-targeted bispecific T-cell engager, shows high potency and sensitivity in preclinical models of small-cell lung cancer. Clin Cancer Res. 2021;27(5):1526-1537. doi:10.1158/1078-0432.CCR-20-2845.
6. Baeuerle PA, Kufer P, Bargou R. BiTE: Teaching antibodies to engage T-cells for cancer therapy. Curr Opin Mol Ther. 2009;11(1):22-30.
7. Ahn MJ, Cho BC, Felip E, et al. Tarlatamab for patients with previously treated small-cell lung cancer. N Engl J Med. 2023;389(22):2063-2075. doi:10.1056/NEJMoa2307980/.
8. Rojo F, Corassa M, Mavroudis D, et al. International real-world study of DLL3 expression in patients with small cell lung cancer. Lung Cancer. 2020;147:237-243. doi:10.1016/j.lungcan.2020.07.026.

Plan outlines community-driven strategies to improve health outcomes across the Upstate

Bon Secours has launched a new, three-year Community Health Improvement Plan (CHIP), designed to address the health priorities identified by residents, community organizations and public health leaders across the region.

Developed through the months-long Community Health Needs Assessment (CHNA) process, the plan reflects feedback from community members and local stakeholders, combined with health data and community trends, to identify the issues having the greatest impact on health and well-being throughout the region.

Over the next three years, Bon Secours will focus its efforts on four priority areas: housing insecurity, food insecurity, mental and behavioral health as well as access to care. The CHNA process highlighted a growing shortage of truly affordable housing in Greenville County and, for the first time in the health system’s CHNA process, identified food insecurity as a critical community issue.

“Addressing food and housing insecurity, mental and behavioral health, and access to care for older adults and under-resourced communities is essential to building a healthier, more resilient Greenville, because every neighbor deserves the stability, dignity and opportunity to thrive,” said Sean Dogan, director of community health, Bon Secours.

The Community Health Improvement Plan outlines strategies and investments across all four priority areas identified by the community. Achieving meaningful progress will require collaboration across the community. Bon Secours will work alongside affordable housing-related organizations, Greenville County and independent recreation centers, local faith communities and nonprofit organizations to align resources, strengthen support networks and improve access to critical social and health services for residents throughout the region.

A key example of how the CHIP is already being put into action is Bon Secours’ participation in the federal Moving to Work program, led locally by the Greenville Housing Authority. Through the initiative, Bon Secours associates connect participants with partner organizations that aid medical and social determinants of health needs, helping individuals and families move toward greater self-sufficiency. The health system also supports affordable housing through investments in organizations like Habitat for Humanity.

The CHIP for the Bon Secours – Greenville market is one of 11 plans recently launched across Bon Secours Mercy Health. While each plan reflects the unique needs of its local community, all reinforce the ministry’s commitment to improving health outcomes, advancing health equity and addressing the social and economic factors that influence health and well-being.

“Community health is about looking beyond the walls of our hospitals and understanding the factors that shape health in people’s everyday lives,” said Gina Hemenway, system director of Community Health, Bon Secours Mercy Health. “This work challenges us to think differently about how we support our patients, families and communities and to build partnerships that can address barriers to health in meaningful, lasting ways.”

The Community Health Improvement Plan for Bon Secours is available at: https://www.bonsecours.com/about-us/community-commitment/community-health-needs-assessment

About Bon Secours Mercy Health 

Bon Secours Mercy Health (BSMH) is a global Catholic health ministry in the United States, Ireland and the Philippines. A $14 billion organization, BSMH delivers care and health services through 47 hospitals and a network of approximately 60,000 associates, including 3,000 providers. BSMH is one of the largest health systems in the United States and the largest not-for-profit private healthcare provider in Ireland. Its diverse portfolio of companies includes advisory and technology-enabled solutions that strengthen clinical quality, operations, data capabilities and financial performance. Rooted in the compassionate ministry of Jesus, BSMH is committed to improving health and well-being and bringing good help to those most in need, especially people who are poor, dying and underserved. Through community investment, access initiatives and efforts to address social drivers of health, the ministry extends its impact beyond its facilities. Through Global Ministries, BSMH also partners locally to support underserved communities in Haiti, Peru, South Sudan and the Philippines, strengthening health, resilience and opportunity. For more information, visit bsmhealth.org(opens in new tab) and follow Bon Secours Mercy Health on social media. 

About Bon Secours 

Bon Secours serves communities across Virginia and South Carolina through a network of hospitals, medical practices and care sites, delivering high-quality, coordinated care that improves outcomes and expands access. Through its integrated approach, Bon Secours strengthens the long-term sustainability of care delivery and extends its impact beyond the walls of its facilities. Bon Secours is part of Bon Secours Mercy Health (BSMH), a global Catholic health ministry operating across the United States, Ireland and the Philippines. Rooted in the compassionate ministry of Jesus, Mercy Health is committed to improving health and well-being throughout our communities, especially those most in need who are poor, dying and underserved. Across its ministry, Bon Secours Mercy Health provides more than $415 million in community benefit each year, supporting programs and initiatives that address social drivers of health and strengthen communities. For more information, visit bonsecours.com(opens in new tab) and follow Bon Secours on social media.