Deal strengthens BMS’s leadership in cell therapy and adds next-generation RNA platform for in vivo CAR-T development
Bristol Myers Squibb (NYSE: BMY) announced it will acquire Orbital Therapeutics, a privately held biotechnology company pioneering RNA medicines designed to reprogram the immune system in vivo. The $1.5 billion all-cash deal expands BMS’s industry-leading cell therapy portfolio with Orbital’s proprietary RNA technology and its lead preclinical candidate, OTX-201, a next-generation CAR T-cell therapy for autoimmune diseases.
Orbital’s OTX-201 uses circular RNA encoding a CD19-targeted CAR, delivered via lipid nanoparticles (LNPs), to trigger in vivo expression of CAR T-cells — effectively transforming the patient’s own body into a CAR T-cell manufacturing system. This approach could significantly reduce treatment burden and broaden accessibility compared to traditional ex vivo CAR T-cell therapies.
The transaction, subject to customary closing conditions and regulatory review under the Hart-Scott-Rodino Act, marks Bristol Myers Squibb’s first major acquisition of 2025. The company has been seeking to diversify beyond mature blockbusters such as Eliquis and Revlimid, reinforcing investor confidence in its long-term growth trajectory through next-generation therapies.
“This agreement with Bristol Myers Squibb, a recognized leader in global medicine, marks a transformational moment for Orbital and the advancement of RNA medicine,” said Ron Philip, Chief Executive Officer of Orbital Therapeutics. “The promising early data from our lead program underscore the potential of our integrated RNA technologies to deliver simpler, safer, and more accessible treatments.”
“With the acquisition of Orbital Therapeutics and its next-generation RNA platform, we have an incredible opportunity to make CAR T-cell therapy more efficient and accessible to more patients,” added Lynelle B. Hoch, President of BMS’s Cell Therapy Organization.
Orbital’s RNA platform integrates circular and linear RNA engineering, advanced LNP delivery, and AI-driven design to enable programmable RNA therapies that can be tailored to a wide range of diseases. Beyond its autoimmune focus, the technology could have broad applications across oncology and other immune-mediated disorders.
This move positions BMS alongside other major pharmaceutical companies racing to develop in vivo cell therapies. AbbVie acquired Capstan Therapeutics in a $2.1 billion deal in June, Gilead’s Kite Pharma purchased Interius BioTherapeutics for $350 million in August, and AstraZeneca made a $1 billion buyout of EsoBiotec earlier this year.
BMS has been steadily building its cell therapy capabilities since its 2019 acquisition of Celgene, which brought in CAR T programs from bluebird bio and Juno Therapeutics. Earlier this year, it also acquired 2seventy bio for $286 million, consolidating full ownership of Abecma, a CAR T therapy for multiple myeloma.
Founded in 2022 and backed by Arch Venture Partners and other investors, Orbital Therapeutics raised $270 million in 2023 to advance its RNA platform under the leadership of former Spark Therapeutics CEO Ron Philip. The company identified in vivo CAR T-cell therapies as its first clinical focus — a vision that now aligns with BMS’s strategy to drive innovation in autoimmune and cell-based therapies.
Transaction expands Runway’s healthcare and life sciences footprint and strengthens its specialty finance platform
Runway Growth Finance Corp. (Nasdaq: RWAY) announced it has entered into a definitive merger agreement to acquire SWK Holdings Corporation (Nasdaq: SWKH) in a net asset value (“NAV”)-for-NAV transaction valued at approximately $220 million, based on SWK’s June 30, 2025 financials and estimated transaction expenses. The deal combines two specialty finance firms with complementary portfolios and shared focus on non-dilutive, growth-oriented capital solutions.
Under the terms of the agreement, consideration to SWK stockholders will include $75.5 million in Runway Growth shares valued at closing NAV per share and approximately $145 million in cash, subject to final NAV adjustments prior to closing. In addition, Runway Growth Capital LLC, Runway’s external investment adviser and an affiliate of BC Partners Advisors L.P., will contribute $9 million in cash to SWK stockholders, separate from the primary merger consideration.
Strategic Expansion in Healthcare and Life Sciences
The merger significantly enhances Runway’s exposure to the healthcare and life sciences sectors. Upon completion, healthcare investments will comprise approximately 31% of Runway’s portfolio, up from 14% as of June 30, 2025. The combined company will have an estimated $1.3 billion in total assets, providing greater scale, diversification, and a broader investment platform for future growth.
SWK Holdings specializes in providing minimally dilutive financing to small- and mid-sized, commercial-stage healthcare companies through structured debt, royalty monetization, and asset-based transactions. Integrating SWK’s portfolio and experienced life sciences team will expand Runway’s deal sourcing and underwriting capabilities in one of the fastest-growing areas of specialty finance.
Enhanced Financial Profile and Growth Opportunities
Runway expects the transaction to be accretive to net investment income (NII) by the first full quarter post-closing, generating mid-single-digit run-rate NII accretion, while improving dividend coverage and return on equity (ROE). The company also anticipates a pro forma leverage ratio increase, expanding its nominal borrowing capacity and supporting continued risk-adjusted returns.
“This transaction meaningfully advances our strategy to diversify and optimize our portfolio by adding SWK’s high-quality investments in healthcare and life sciences,” said David Spreng, Founder and CEO of Runway Growth Finance. “We’re enhancing our earnings power while reinforcing portfolio strength and positioning for long-term value creation. With the support of BC Partners, we continue to pursue both organic and inorganic growth opportunities as a permanent capital vehicle backed by the $10 billion BC Partners Credit platform.”
A Repeatable Blueprint for Growth
Runway described the merger as a non-dilutive, repeatable model for future transactions within the venture and growth lending ecosystem. The company expects to benefit from both expanded scale and greater market visibility through the issuance of Runway Growth shares to SWK stockholders, broadening its shareholder base and trading liquidity.
Company Overviews
Runway Growth Finance Corp. is a specialty finance company providing flexible debt and structured financing to late- and growth-stage companies seeking an alternative to equity dilution. The company operates as a closed-end investment fund regulated as a business development company (BDC) under the Investment Company Act of 1940 and is externally managed by Runway Growth Capital LLC.
SWK Holdings Corporation is a life sciences-focused specialty finance company that partners with small- and mid-sized healthcare firms to fund the development and commercialization of medical technologies. Its customized financing solutions typically range from $5 million to $25 million and are designed to support long-term value creation while minimizing equity dilution.
Novo Nordisk is making another bold move in the metabolic disease space with its latest agreement to acquire Akero Therapeutics for up to $5.2 billion, marking one of the year’s largest biotech takeovers. The deal strengthens Novo Nordisk’s expanding presence in liver and metabolic disorders, while delivering significant value to Akero’s shareholders.
Under the terms of the agreement announced Thursday, Akero investors will receive $54 per share in cash at closing, plus a contingent value right (CVR) worth up to an additional $6 per share. The CVR payment would be triggered upon full U.S. regulatory approval of Akero’s lead drug candidate, efruxifermin (EFX), for treating compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) by June 2031.
The acquisition values Akero at roughly $4.7 billion upfront, representing a 42% premium to its pre-rumor share price earlier this year. If all conditions are met, the total value could reach $5.2 billion — a 57% premium compared to Akero’s May 2025 valuation.
For Novo Nordisk, the deal builds on its leadership in GLP-1–based therapies and signals a deepening commitment to addressing complex metabolic diseases. Akero’s EFX program, designed to treat MASH, a condition historically known as NASH (nonalcoholic steatohepatitis), complements Novo Nordisk’s existing pipeline of cardiometabolic treatments. EFX’s potential to reverse fibrosis and improve liver function positions it as a promising therapy for millions of patients with few available options.
MASH has become a growing global health concern, closely linked to obesity and type 2 diabetes—areas where Novo Nordisk already dominates through blockbuster drugs like Ozempic and Wegovy. Integrating Akero’s research could help the Danish pharmaceutical giant extend its reach beyond diabetes and into liver health, strengthening its competitive advantage as demand for metabolic therapies surges worldwide.
Industry analysts see the deal as part of a broader wave of consolidation among biotechs developing metabolic and inflammatory treatments. Major pharmaceutical companies are increasingly acquiring smaller firms with advanced-stage assets to accelerate innovation and diversify revenue streams.
Akero’s ongoing Phase 3 SYNCHRONY trials have shown encouraging signs that EFX can reduce fibrosis and resolve MASH, potentially transforming the standard of care. The company’s holistic approach — improving both liver health and cardiovascular risk factors — aligns well with Novo Nordisk’s long-term goal of offering comprehensive solutions for metabolic dysfunction.
Following the acquisition, Akero’s operations will be integrated into Novo Nordisk’s global research network, with plans to advance EFX through late-stage trials and prepare for commercial launch. The transaction, unanimously approved by Akero’s board, is expected to close by year-end pending shareholder and regulatory approvals.
Financial advisors for the deal include Morgan Stanley and J.P. Morgan Securities, with Kirkland & Ellis LLP serving as legal counsel to Akero.
The acquisition underscores Novo Nordisk’s strategy to expand beyond diabetes and obesity treatments into adjacent metabolic diseases with large unmet medical needs. If EFX achieves approval and commercial success, the deal could mark a defining moment in the evolution of liver disease therapeutics—and another milestone in Novo Nordisk’s transformation into a powerhouse across metabolic health.
STAFFORD, Texas, Oct. 02, 2025 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Belgium.
The Company’s application to European regulators has been formally approved, adding Belgium as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, and the US.
According to the latest data collected by the European Cancer Information System (click here), a total of 11,366 new cases of breast cancer were diagnosed in Belgium in 2022, which is the most common cancer diagnosed in women, representing approximately 33% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Belgium with 2,324 deaths in 2022.
The Company is collaborating with Patrick Neven, MD, PhD, at UZ Leuven, who will be serving as the national principal investigator in Belgium for FLAMINGO-01. Dr Neven is Full Professor at the Department of Gynecological Oncology, University Hospitals Leuven, and is a staff member of the Multidisciplinary Breast Centre. His research focuses on breast oncology, particularly endocrine therapy and quality of life. He has served as principal investigator in multiple clinical trials, published over 300 peer-reviewed papers, and lectured widely at international meetings. He is president of the Belgian Society of Senology, active in several scientific societies, and has mentored numerous doctors and PhD students in breast cancer care.
CEO Snehal Patel commented, “We thank our steering committee for introducing us to Dr. Neven and look forward to working with him and his colleagues. We are planning start-up activities in Leuven in the coming month. Leuven is centrally located in Belgium and is an ideal location to cover large parts of the country, including Brussels and Antwerp.”
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com
CERRITOS, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) — The Oncology Institute (NASDAQ: TOI), a pioneer in value-based community oncology care, today announced that Dr. Daniel Virnich, Chief Executive Officer, and Rob Carter, Chief Financial Officer, will participate in the Noble Capital Markets Emerging Growth Virtual Equity Conference, on October 8, 2025, including a presentation at 11:00am ET.
Interested parties can access a webcast of the presentation by registering at the link listed on the Investor Relations section of the Company’s websites at https://investors.theoncologyinstitute.com/.
Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.
CERRITOS, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) — The Oncology Institute (NASDAQ: TOI), a pioneer in value-based community oncology care, is pleased to announce a new partnership with Protocol Behavioral Health, a leading provider of evidence-based mental health care for cancer patients. This collaboration underscores TOI’s commitment to delivering whole-person care by integrating behavioral health services directly into the cancer care journey.
Research shows that approximately 30% of cancer patients experience significant depression or anxiety, and oncologists widely agree that behavioral health support can benefit nearly every patient. Through this partnership, TOI patients will gain timely access to mental health services that are tailored specifically to the emotional and psychological challenges of cancer, with no waitlists and full integration into the patient’s care team, and the added benefit of services offered in multiple languages to support our diverse patient population.
“Anxiety and depression can greatly threaten a patient’s outcome by affecting their ability to complete treatment in the recommended time,” said Yale Podnos, MD, Chief Medical Officer at The Oncology Institute. “By embedding behavioral health services directly into our care model, we’re closing a critical gap in oncology and ensuring our patients have access to the support they need, exactly when they need it.”
Key Benefits of the Partnership:
Integrated Care Delivery: Protocol clinicians collaborate with TOI providers using the Collaborative Care Model (CoCM), an evidence-based framework proven to improve outcomes through team-based care.
Improved Access: Patients receive behavioral health support without delays, removing a major barrier to care in traditional mental health systems.
Specialized Expertise: Protocol’s behavioral health care managers and psychiatric providers are trained specifically to support oncology patients through diagnosis, treatment, survivorship, and beyond.
Improved Patient Outcomes: Studies link integrated behavioral health care to better treatment adherence, quality of life, and patient satisfaction.
“We founded Protocol to meet a clear need in oncology,” said Cara Bohon, PhD, Chief Clinical Officer of Protocol Behavioral Health. “Through this partnership, we’re ensuring that mental health care is not a luxury or an afterthought; it’s a core part of the patient’s treatment plan from day one.”
Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.
Protocol Behavioral Health provides timely, evidence-based mental health care tailored to the unique needs of cancer patients. Using the Collaborative Care Model, Protocol integrates behavioral health managers and psychiatric providers directly into oncology care teams. This model ensures seamless coordination, personalized support, and better outcomes for patients experiencing depression, anxiety, and other behavioral health challenges.
Danish biotechnology company Genmab (Nasdaq: GMAB) has agreed to acquire Dutch oncology firm Merus (Nasdaq: MRUS) in an all-cash transaction valued at roughly $8 billion, a move that significantly expands Genmab’s late-stage pipeline and accelerates its push toward a fully owned operating model.
Under the terms of the deal, Genmab will pay $97.00 per share for all outstanding common shares of Merus, representing a premium of more than 40% over Merus’ most recent closing price. The boards of both companies have unanimously approved the transaction, which is expected to close by the first quarter of 2026 pending regulatory and shareholder approvals.
The acquisition brings Merus’ lead asset, petosemtamab, into Genmab’s pipeline. The bispecific antibody therapy, currently in Phase 3 clinical trials, has received two Breakthrough Therapy Designations from the U.S. Food and Drug Administration for treatment of head and neck cancers. Recent Phase 2 data presented at the 2025 ASCO meeting indicated promising efficacy, with outcomes surpassing standard of care benchmarks.
The addition of petosemtamab is expected to bolster Genmab’s transition to a fully owned model, reducing reliance on partnerships and collaborations. By 2027, Genmab anticipates four proprietary programs reaching the commercial stage, positioning the company for multiple new product launches within oncology.
Petosemtamab’s potential launch as early as 2027 could deliver significant commercial impact, with projections suggesting annual sales of $1 billion by 2029 and the possibility of multi-billion-dollar revenues in the longer term. Genmab expects the acquisition to become accretive to EBITDA before the end of the decade.
The $8 billion consideration will be financed through a combination of cash on hand and approximately $5.5 billion in debt, backed by commitments from Morgan Stanley Senior Funding. Genmab stated it remains committed to deleveraging, with a target of reducing gross leverage below three times within two years of closing.
A tender offer for Merus shares will launch in the coming weeks. If successful, the transaction will result in Merus becoming a wholly owned subsidiary of Genmab. Shareholders who do not tender their shares are expected to receive equivalent value through statutory buy-out proceedings in the Netherlands.
The deal highlights the intense competition among biotech companies to secure late-stage oncology assets with strong regulatory momentum. By integrating Merus’ multispecific antibody expertise, Genmab gains not only a promising drug candidate but also a platform that complements its own antibody development technologies.
For Merus, the acquisition provides the scale and resources of a global biotechnology leader to advance petosemtamab through late-stage development, regulatory review, and potential commercialization.
With a strong balance sheet, an expanded pipeline, and an emphasis on proprietary innovation, Genmab is positioning itself to compete more directly with larger global oncology players in the second half of the decade.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
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Milestone in Findhelp partnership. SelectQuote announced that it has referred more than 200,000 low-income seniors to Findhelp, with nearly 50,000 of those individuals accessing free or reduced-cost services. The milestone demonstrates SelectQuote’s role in addressing the needs of Medicare-eligible consumers.
Partnership connects consumers to critical support. Findhelp is a closed-loop referral management software platform that connects individuals with community resources such as food, housing, transportation, and financial aid. SelectQuote has partnered with Findhelp for several years, directing seniors to assistance programs. The initiative does not generate revenue, but it extends SelectQuote’s Medicare distribution model by providing tangible value to consumers.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Pfizer Inc. (NYSE: PFE) has announced plans to acquire Metsera, Inc. (NASDAQ: MTSR), a clinical-stage biopharmaceutical company developing next-generation obesity and cardiometabolic treatments. The all-cash deal, valued at $47.50 per share, represents an enterprise value of approximately $4.9 billion, with the potential for an additional $22.50 per share in contingent milestone payments tied to clinical and regulatory approvals.
The acquisition marks Pfizer’s most significant push yet into the rapidly growing obesity treatment market, an area forecasted to reach hundreds of billions in value globally over the coming decade. With over 200 health conditions linked to obesity, pharmaceutical companies are racing to develop therapies that offer stronger efficacy, fewer side effects, and more convenient dosing schedules.
Metsera brings to Pfizer a diverse pipeline of incretin and amylin programs, including both injectable and oral formulations designed to improve weight loss outcomes. Its lead candidates include:
MET-097i, a weekly and monthly injectable GLP-1 receptor agonist currently in Phase 2 trials.
MET-233i, a monthly amylin analog in Phase 1 development, being tested both as monotherapy and in combination with MET-097i.
Two oral GLP-1 receptor agonist candidates expected to begin clinical trials in the near term.
Additional preclinical nutrient-stimulated hormone therapeutics under development.
Preliminary clinical data for MET-233i presented at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) indicated a potentially best-in-class profile, with strong durability and tolerability supporting less frequent injections.
Pfizer expects to leverage its global clinical, manufacturing, and commercial infrastructure to accelerate the development of Metsera’s portfolio. The acquisition aligns with the company’s broader strategy of expanding into high-growth therapeutic areas where demand is accelerating.
Under the agreement, Metsera shareholders will receive $47.50 in cash upon closing, with the possibility of an additional $22.50 per share through contingent value rights (CVRs). These CVRs include:
$5 per share upon the initiation of a Phase 3 trial for the MET-097i + MET-233i combination.
$7 per share upon U.S. FDA approval of MET-097i as a monthly monotherapy.
$10.50 per share upon FDA approval of the monthly MET-097i + MET-233i combination.
If all milestones are achieved, the transaction value could exceed $7 billion.
The deal has been unanimously approved by both companies’ boards of directors and is expected to close in the fourth quarter of 2025, subject to regulatory approval and shareholder consent.
With this acquisition, Pfizer joins competitors such as Eli Lilly and Novo Nordisk in intensifying the race to dominate the obesity treatment market. By combining Metsera’s innovative science with Pfizer’s scale, the company aims to deliver next-generation weight management solutions to millions of patients worldwide.
Eli Lilly (NYSE: LLY) announced plans to invest $6.5 billion in a new manufacturing facility in Houston, Texas, designed to expand production of its pipeline of small molecule medicines, including the company’s highly anticipated oral obesity pill, orforglipron.
The facility will be the second of four new U.S.-based plants Lilly intends to open over the next five years, following a February pledge of at least $27 billion in domestic manufacturing investments. This adds to more than $23 billion the company has already spent since 2020 to scale operations in response to soaring demand for obesity and diabetes therapies.
The Houston site will play a critical role in Eli Lilly’s efforts to maintain its competitive lead in the rapidly expanding market for GLP-1 drugs. Unlike existing weekly injectable treatments, orforglipron is designed as an oral pill, offering patients a simpler alternative without food or water restrictions. Analysts believe the convenience factor could make orforglipron a blockbuster treatment if approved by regulators.
The race to scale production has become increasingly urgent. Both Eli Lilly and rival Novo Nordisk have faced supply challenges as demand for weight-loss medications surged across the United States. By boosting capacity, Lilly aims to ensure orforglipron can be manufactured at scale and delivered to tens of millions of patients worldwide.
The Houston facility will also support manufacturing of other small molecule medicines across a range of therapeutic areas, including cardiometabolic disease, oncology, immunology, and neuroscience. Small molecule drugs, which are typically produced in pill form, are generally easier and cheaper to manufacture than injectables, making them more accessible for patients and more efficient to scale globally.
In addition to strengthening its supply chain, Eli Lilly highlighted the economic impact of the new site. The project is expected to create 615 permanent jobs in the Houston area, spanning roles such as engineers, scientists, operations staff, and lab technicians. During construction, the facility will generate more than 4,000 temporary jobs, further supporting the region’s economy.
The company also emphasized that the move supports broader U.S. efforts to re-shore pharmaceutical manufacturing. In recent years, political pressure has mounted to reduce reliance on overseas drug production. By expanding its domestic footprint, Lilly positions itself as a leader in bringing pharmaceutical manufacturing back to the U.S. while meeting escalating global demand for obesity treatments.
With four new U.S. plants scheduled to be operational within five years, Eli Lilly is positioning itself at the forefront of the next generation of obesity and metabolic care. The Houston facility is expected to serve as a cornerstone of that strategy, ensuring supply can keep pace with demand in one of the fastest-growing markets in modern medicine.
Practice earns maximum quality points on avoidable ED visits and admissions, saving more than $3,500 per episode
CERRITOS, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) — The Oncology Institute of Hope and Innovation (NASDAQ: TOI), a leading value-based oncology practice, achieved $1.1 million in Medicare savings during Performance Period 2 of the Centers for Medicare & Medicaid Services’ Enhancing Oncology Model (EOM) through its California professional corporation, with savings equating to more than $3,500 per patient episode. TOI earned the maximum score on avoidable emergency department visits and hospital admissions. Results were driven by our High Value Cancer Care program conducted by Health Care Coaches and 24/7 symptom management support that helped patients stay on treatment and out of the hospital.
EOM is a voluntary total-cost-of-care model created by the CMS Innovation Center to advance high-quality, person-centered, and equitable cancer care for Medicare Fee-for-Service beneficiaries.
“These results again prove that our proactive navigation and real-time symptom management reduce unnecessary hospital visits and keep patients on treatment,” said Dr. Yale D. Podnos, Chief Medical Officer and President of Practice. “Patients across all our markets have access to these proven best practices to ensure each patient receives the right care at the right time.”
“This performance reinforces TOI’s leadership in value-based oncology,” said Dan Virnich, Chief Executive Officer. “By delivering measurable savings while improving quality, we continue to demonstrate that high-value cancer care is both clinically superior and financially sustainable.”
TOI’s success in EOM builds on its track record in CMS’s prior Oncology Care Model, where the organization exceeded quality standards and generated multi-million-dollar savings for Medicare.
About The Oncology Institute (www.theoncologyinstitute.com): Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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OCU400 Licensing Completed. Ocugen has announced the completion of a licensing agreement for Korea with Kwangdong Pharmaceutical, Co., Ltd., a diversified pharmaceutical company in the Republic of South Korea. This finalizes the term sheet announced in August with the 2Q25 business update. We have based our revenue expectations on US and Europe, with the Korea agreement adding additional cash upon the signing and downstream royalties.
Agreement Provides Cash, Milestones, and Royalties. The terms provide Ocugen with signing and near-term milestones of $7.5 million. Under the agreement, Ocugen will manufacture and supply OCU400 in exchange for a royalty of 25% of Net Sales plus sales milestones of $1 million for every $15 million in Net Sales, or roughly 32% per $15 million in sales. There are an estimated 7,000 retinitis pigmentosa (RP) patients in Korea, with an estimated market of about $180 million over the first 10 years of sales. We estimate these potential payments at about $65 million to Ocugen.
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CHATHAM, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the successful completion of a Type B Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of TNX-102 SL (sublingual cyclobenzaprine HCl) for the treatment of major depressive disorder (MDD). The Company received positive feedback from the FDA and plans to pursue a supplemental new drug application (sNDA) to expand the therapeutic indication of TNX-102 SL to include MDD, based on exploratory findings suggesting that improving sleep quality may positively impact depressive symptoms.
“We are pleased with the outcome of our Pre-IND meeting with the FDA and appreciate their thoughtful guidance,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “This marks a significant step forward in our efforts to develop TNX-102 SL as a novel treatment for MDD, a condition that affects millions and remains underserved by current therapies that are often difficult to tolerate.”
“We believe bedtime TNX-102 SL has the potential to be a first-in-class treatment that is designed to target the reduced quality and quantity of slow wave sleep associated with depression,” said Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “TNX-102 SL is a tertiary amine tricyclic that is designed for transmucosal absorption to bypass first pass hepatic metabolism. In contrast, FDA-approved tertiary amine tricyclic antidepressants are swallowed pill formulations, that are largely metabolized by first-pass to longer-lived secondary amine tricyclics. Also, the FDA-approved tertiary amine tricyclic antidepressants are only active in treating MDD at more than ten times the dose employed with TNX-102 SL and can adversely impact weight, blood pressure, cognition, and sexual function.”
The FDA provided constructive feedback during the Pre-IND meeting for TNX-102 SL in MDD and found the proposed long-term safety data collection plan generally reasonable, potentially streamlining the development path.
An IND filing is planned for Q4 2025, positioning the program to enter Phase 2 clinical trials shortly thereafter. TNX-102 SL is FDA approved for the treatment of fibromyalgia, under the brand name Tonmya™. In the Phase 3 RESILIENT study of fibromyalgia patients, the TNX-102 SL – treated group had activity on improving depression over placebo by the Beck Depression Inventory (BDI), with an uncorrected p-value < 0.05. The biological relationship between depressed symptoms in fibromyalgia and those in MDD is not understood.
About TNX-102 SL TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride that enables rapid transmucosal absorption and reduces production of the long half-life active metabolite, norcyclobenzaprine, by bypassing first-pass hepatic metabolism. As a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. It is currently approved in the U.S. as a once-daily bedtime treatment for fibromyalgia in adults. TNX-102 SL is also in development as a daily bedtime treatment for acute stress reaction/acute stress disorder. Tonix also holds active IND’s for the following indications for TNX-102 SL: Long COVID (post-acute sequelae of COVID-19), PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary composition. These patents are expected to provide Tonmya with U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044.
Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix recently received FDA approval for Tonmya™, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology and infectious diseases. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures. Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established. Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
