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

1. Ruemu Ejedafeta Birhiray, Maya Nicole Birhiray. Clinical research in the community. Hematology Am Soc Hematol Educ Program 2023; 2023 (1): 324–331. doi: https://doi.org/10.1182/hematology.2023000432.
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. 

SOUTH CAROLINA – September 17, 2026 – Iluminos Therapeutics, headquarterd in Phoenix, Arizona, is pioneering novel small-molecule pipeline programs to address profound unmet medical needs across central nervous system disorders and metabolic diseases. Its lead clinical candidate targets DYRK1A and its critical downstream pathways to deliver transformative, disease-modifying outcomes across four high-value indications: Alzheimer’s disease, related tauopathies, Down syndrome and Type 1 diabetes.

Solutions

Iluminos has engineered best-in-class small-molecule inhibitors that selectively inhibit and degrade DYRK1A, thereby addressing core drivers of neuroinflammation and proteinopathy. Its lead candidate significantly reduces aberrant tau and amyloid accumulation while dampening persistent neuroinflammation across robust mouse models of Alzheimer’s disease, frontotemporal dementia (FTD) and Down syndrome.

Demonstrating high oral bioavailability and exceptional safety, the compound features a wide therapeutic window and favorable safety margins across preclinical models. IND-enabling studies are actively underway to advance its lead candidate into first-in-human clinical trials.

Strengths

• Targeting a Key Regulator of Neurodegeneration: Iluminos directly targets DYRK1A, a central kinase driving key neuroinflammatory and neurodegenerative pathways.
• First-in-Class Dual Action: Iluminos’ best-in-class pipeline offers unmatched potency and selectivity. Unlike traditional inhibitors, its proprietary compounds both inhibit DYRK1A activity and induce its selective degradation.
• Robust, Defensible IP Position: Iluminos holds exclusive rights to a deep patent portfolio covering advanced small molecules, ensuring broad freedom to operate and commercial exclusivity.
• Multibillion-Dollar Opportunity in High-Unmet-Need Markets: Its lead clinical asset addresses Alzheimer’s disease, related tauopathies and Down syndrome, targeting disease-modifying therapies for more than 50 million underserved patients worldwide.

Meet the Team

From left to right:

Travis Dunckley, Ph.D. | Co-founder

Christopher Hulme, Ph.D. | Co-founder

The City of Rock Hill announced it is committing $250,000 from its economic development fund to York Technical College to help ensure local students have access to opportunities created by the region’s economic growth. The one-time investment will support the College’s efforts to develop programs and training aligned with emerging industries and future-focused careers, including life sciences.

“This investment is a shared commitment to ensuring the people who live here are prepared to participate in and benefit from the economic opportunities being created right here in York County,” said Dr. Stacey Moore, president of York Technical College. “The City of Rock Hill has been a valued partner and supporter of York Tech and our mission for decades. We are deeply grateful for that partnership and for the City’s continued belief in the importance of creating opportunities for our people and communities.” 

York Tech is developing South Carolina’s first life sciences training center and recently purchased the former Rock Hill Business Technology Center, which will serve as a site for life sciences training, health and human services programs, building construction trades, and other program areas aligned with local workforce needs. 

The investment comes at a critical time for Rock Hill and York County, as life sciences and other emerging industries bring new opportunities to the region. With Octapharma’s planned $1.5 billion biopharmaceutical manufacturing facility at the Palmetto Research Park, York Technical College is expanding its role in preparing the skilled workforce needed to support life sciences and biomanufacturing. The project is expected to create more than 1,500 jobs. 

“Our responsibility is to help people access opportunities that allow them to define and pursue success for themselves,” Dr. Moore said. “At the same time, we have a responsibility to the businesses and industries that are investing in our region to ensure they have the skilled workforce they need. This significant contribution from the City helps us continue doing both.” 

Rock Hill Mayor John Gettys emphasized the need to ensure that economic development creates opportunities for local residents, noting York Technical College’s long-standing role in preparing the community for what’s ahead.  

York Technical College’s workforce role extends beyond life sciences. The College serves as a regional workforce development partner for the Carolinas Grid Engine, a National Science Foundation-supported initiative spanning 36 counties in North and South Carolina. Through certificates, apprenticeships, and degree programs in industrial and engineering technologies, York Technical College will prepare workers for the modernization of the electric grid. 

Through innovation and strong collaboration with employers, community partners, and local leaders, the College will continue preparing the region and it’s people for what’s next.

The City of Rock Hill is also providing a $250,000 one-time gift to Winthrop University, recognizing the important role both institutions play in serving the Rock Hill community. 

About York Technical College 

As a public, two-year institution, York Technical College offers associate degrees, diplomas, and certificates in over 100 programs of study, as well as an award-winning program that will allow you to transfer to a four-year institution. Founded in 1964 with just 60 students, York Technical College now welcomes between 5,000 to 7,000 credit students each year at its main campus in Rock Hill, South Carolina, as well as its off-campus center in Chester, South Carolina.  

Media Contact: Amanda Kaufmann, Director of Strategic Communications and Marketing, York Technical College Email: AKaufmann@yorktech.edu Cell: 803-280-3242 

For every life sciences company, daily operating costs add up quickly. Lab supplies, personal protective equipment (PPE), staffing and other essential purchases are necessary to keep the business operating, but they also become a major expense.

Those costs are becoming harder to ignore. In fact, Deloitte’s 2026 Life Sciences Outlook found that almost four in 10 executives expected inflation, broader economic pressure and supply chain risks to shape the year.

That means that cost control is less about spending and more about finding ways to purchase the products and services the business needs.

Last year, PAI Pharma did exactly that through SCbioEdge, a savings and rewards program that gives members access to negotiated pricing on products and services, helping them lower costs without adding complexity to their purchasing process.

By the end of the year, the Greenville-based leader in pharmaceutical manufacturing saved nearly $1.9 million, with a significant portion of those savings coming from one strategic shift: moving its laboratory supplies and PPE purchasing to Fisher Scientific, a preferred SCbioEdge supplier.

PAI Pharma also implemented a Vendor Managed Inventory (VMI) system for PPE. Through the program, Fisher’s supply chain experts monitor, stock and replenish PAI Pharma’s PPE inventory, which helps prevent stockouts, reduce excess inventory and ease the administrative burden on PAI Pharma’s team.

“The success of the VMI program demonstrates the value of PAI Pharma’s relationship with Fisher Scientific and SCbio,” said Kristin Roosevelt, senior director of biotechnology at Thermo Fisher Scientific. “Together, we can support PAI’s growing organization with greater supply continuity, quality and compliance, and efficiency across the supply chain.”

The impact goes beyond the cost of the supplies themselves.

“We have what we need, on time, every week without concern, and our onsite storage is better utilized,” said Sarah Grabowski, vice president of supply chain with PAI Pharma.

With less time spent on monitoring inventory and managing routine purchasing, PAI Pharma’s team can stay focused on its core work: manufacturing and delivering essential medicines to patients.

How PAI Pharma Put SCbioEdge to Work

PAI Pharma’s experience shows how SCbio members can turn the collective purchasing power of SCbioEdge into measurable savings. Membership – SCbio

Through SCbio and MassBio, the program connects members with preferred suppliers offering negotiated pricing across a range of products and services. But making the most of that purchasing power comes with understanding where the opportunities can be put to use.

That was PAI Pharma’s first step.

As a leading developer, manufacturer, and distributor of pharmaceuticals serving hospitals, institutional and retail care settings nationwide, PAI Pharma has purchasing needs across many areas of its business.

Its team looked across departments, including Production, Laboratory, HR and IT, to identify areas of spend and determine where SCbioEdge could have the greatest immediate impact.

“Knowing where our greatest expenditure was allowed PAI Pharma to focus on immediate needs and match with the SCbio suppliers best suited to service those areas,” Grabowski said.

That approach gave PAI Pharma a practical way to prioritize the program. Rather than changing purchasing power across the organization all at once, the company focused first on the areas where negotiated pricing and preferred suppliers could deliver the most value.

The result was nearly $1.9 million in savings in one year.

More than Savings: The Extended Value of an SCbio Membership

PAI Pharma also found that getting started with SCbioEdge didn’t require a lengthy or complicated rollout. Grabowski encourages members to take a look at the program if they’ve not yet explored it. Getting started is as simple as contacting the team, and a representative will reach out directly.

“Those members not yet taking advantage of the buying power of SCbioEdge programs should know that the program is easy to adopt, and you can start saving quite immediately,” Grabowski said.

For PAI Pharma, however, the value of SCbio membership extends beyond SCbioEdge. The company used its membership to increase its visibility across South Carolina’s life sciences ecosystem, connect with industry partners through SCbio events and highlight its role as a major Upstate employer.

Together, those benefits demonstrate the broader value the company has found in its membership: stronger connections, greater visibility, and nearly $1.9 million in savings through SCbioEdge.

For other SCbio members, PAI Pharma’s experience offers a straightforward place to start: look at where the business is already spending the most, identify the SCbioEdge partners that serve those needs and see where the program’s purchasing power can make a difference.

About PAI Pharma

PAI Pharma (“PAI”) is a leading US-based developer, manufacturer, and distributor of pharmaceuticals, serving hospital, institutional, and retail care settings nationwide. Through its strong domestic manufacturing footprint, PAI manufactures and distributes a broad portfolio of essential generic medicines, including hospital-focused injectables, IV therapies, ready-to-use formulations, and oral liquid products. With more than five decades of experience, PAI is committed to quality, affordability, and strengthening the resilience of the U.S. pharmaceutical supply chain.

SCbio is pleased to welcome Jason Colgate, general partner at Coddle Creek Capital, to its Strategic Advisory Board.

Colgate brings more than 25 years of experience across venture capital, private equity, corporate investing and life sciences operations, with a passion for advancing innovative healthcare and life sciences companies.

At Coddle Creek Capital, Colgate helps lead a team of 12 life sciences investors and operators focused on advancing genomics-informed ventures. He is guiding the launch of CCC’s Venture Fund II, which targets up to $150 million and is supported by a strong portfolio performance and anchor commitments from limited partners and general partners that exceed half of the fund’s first-close goal.

Prior to joining CCC, Colgate held executive and clinical leadership roles at Boston Scientific and IQVIA and served as an institutional investor at Johnson & Johnson Development Corporation. He also led multibillion-dollar healthcare investments, buyouts and exits through Bourne Capital Partners and a Berkshire Hathaway-style family office, working alongside firms including Carlyle, TPG and Cerberus.

Based at the North Carolina Research Campus in greater Charlotte, Colgate and CCC work within one of the nation’s most concentrated genomics and precision nutrition hubs. Their investments include collaboration with Duke, the University of North Carolina, North Carolina State, Appalachian State and other North Carolina universities based there. CCC also owns Eremid Genomics Lab, a Contract Research Organization that provides specialized infrastructure for biotech and precision health companies.

Colgate and his team take an active-investor approach, serving as both capital and operating partners to help companies navigate critical stages of growth, reduce risk and accelerate value creation. They facilitate this model by being the embedded venture capital fund across the other Carolinas’ innovation hubs, having offices at The Pearl Innovation Center in Charlotte, the Innovation Quarter in Winston-Salem and Blue Sky Labs in Charleston. With another office in New York City, their network also provides a robust national dealflow from other major life sciences markets like Boston and California, which connects them to other leading research institutions such as Stanford, Cornell, MIT and Harvard.

Colgate holds a Master of Business Administration from UNC Chapel Hill’s Kenan-Flagler Business School and a Bachelor of Music in Cello Performance from Vanderbilt University under the Dinah Shore Scholarship. He has served on both private and nonprofit boards, including the Charlotte Symphony Orchestra, where he occasionally performs.

About SCbio

SCbio is the definitive, unifying leader in South Carolina’s life sciences sector, fostering authentic collaboration and innovation across academia, startups, government and established enterprises. As a member-driven economic development organization, SCbio represents an industry that generates $20.1 billion in annual economic impact and supports 63,000 jobs across South Carolina. Our members are unified by a mission to positively impact humanity through science across the ecosystem of advanced and specialty manufacturing; digital health and the data frontier; and cutting-edge health specializations. For additional information about SCbio and the life sciences industry, or to become a member, visit SCbio.org.