BeOne Medicines Ltd.

Gilead is buying the global rights to an oral cancer drug from Genhouse Bio, a China-based biotech that filed for an IPO on the Hong Kong Stock Exchange last month. The California drugmaker is dishing out $80 million upfront for GH31, a MAT2A-targeted synthetic lethality drug for select solid tumors. MAT2A plays a role in metabolic regulation and can be overexpressed in cancer cells. Genhouse could get up to $1.45 billion in biobucks, the company announced Friday on WeChat. A Gilead spokesperson confirmed the deal terms to Endpoints News. The deal gives Gilead access to another oral cancer treatment, after it inked pacts with Kymera and Repare in recent months. Much of the biotech’s oncology focus in recent years, though, has been in cell therapy, antibody-drug conjugates and other antibody-based medicines. Genhouse’s GH31 has gotten clinical trial clearance in both the US and China. The biotech planned to start a Phase 1 in China in the first quarter of this year, it said in its IPO paperwork last month. “The addition of GH31 reflects our disciplined approach to expanding Gilead’s oncology pipeline through innovative science and strong partnerships,” Jackson Egen, Gilead’s SVP of oncology research, said in Genhouse’s announcement. Gilead’s oncology revenues shrank about 2% from 2024 to 2025, the company disclosed during earnings earlier this week. HIV remains its biggest unit. “Unlike the Gilead of 2019, business development is not make-or-break for the story,” BMO analysts wrote in a note after earnings this week. “We’d like to see investment in core areas: liver disease, oncology, and inflammation (although this one seems to be less of a focus recently).” A few drugmakers are working in the MAT2A area, including BeOne Medicines and Ideaya Biosciences. GSK previously partnered with Ideaya on a MAT2A program but pulled out from it in 2022. Going to China Gilead’s Genhouse pact marks at least the 17th deal between a China-based drug developer and a Western biopharma so far this year, according to an Endpoints tally. Gilead has made fewer deals with China-based biotechs than its large pharma peers, some of which have done multiple licensing and collaboration pacts in the region. Last October, Gilead’s cell therapy unit Kite Pharma agreed to a $120 million upfront and up to $1.52 billion biobucks deal with Shenzhen-based Pregene Biopharma in the hot area of in vivo cell therapies. In 2024, Gilead made an antibody deal with Biocytogen Pharmaceuticals for undisclosed terms. That same year, Gilead split from its cell therapy joint venture with Fosun Pharma in China. Genhouse’s pipeline is focused on oncology. Its most advanced drug, GH21, inhibits SHP2. A Phase 3 trial in China is slated for 2027. It aims to gain conditional approval in 2028 for patients with KRAS G12C inhibitor resistance, according to its IPO pitch. The biotech’s pipeline also includes oral small molecule cancer medicines going after the targets ERK1/2, PRMT5, KIF18A, WRN and DHX9. Genhouse disclosed a 300 million RMB (about $43 million) crossover financing last month. The content above comes from the network. if any infringement, please contact us to modify.

TRENTON, N.J., Feb. 12, 2026 /PRNewswire/ -- On February 5 at the Hilton East Brunswick, BioNJ hosted its 33rd Annual Dinner Meeting and Innovation Celebration, featuring an Opening Address by New Jersey Governor Mikie Sherrill and showcasing the innovation and leadership driving the State's life sciences sector. During the event, the organization announced the election of its 2026 Officers and Board Members, bringing together hundreds of industry executives to celebrate collective achievements, honor outstanding contributions and connect through an evening of networking and awards. Newly elected officers include Chair Christopher Cozic, Executive Vice President & Chief People Officer, Genmab; Vice Chair Michael Schoen, Senior Vice President, Head, Government Affairs & Special Assistant to the CEO, BeOne Medicines; Treasurer Christopher Mortko, Ph.D., MBA, Vice President & Head, HQ Search & Evaluation, Merck Corporate Licensing; and Secretary Susan L. Levinson, Ph.D., CEO, BioAegis Therapeutics. Mr. Cozic was unanimously elected by the BioNJ Board as Chair, succeeding Emer Leahy, Ph.D., MBA, President & CEO, PsychoGenics, who now assumes the role of Immediate Past Chair. "We are deeply grateful for Dr. Leahy's stewardship and unwavering commitment to BioNJ over these past two years," said Debbie Hart, President and CEO of BioNJ. "During her chairpersonship, she strengthened our voice, expanded our reach and championed innovation and Patient needs that drove tangible policy and legislative progress across New Jersey. Dr. Leahy's contributions leave a lasting impact that will continue to benefit BioNJ, the life sciences community and, most importantly, Patients." "We look forward to working with incoming Chair Chris Cozic to support our Members during this pivotal time for the industry — one that demands unity, resilience and bold leadership to advance progress for Patients," added Hart. "Mr. Cozic's talent for inspiring others and building strong, mission‑driven teams will be invaluable as we work together to strengthen New Jersey's life sciences ecosystem and advance our mission — to help our Members help Patients." "It's an honor to serve as Chair of BioNJ, a community that represents the heart of New Jersey's biotech and pharmaceutical industry," said Chris Cozic. "Working alongside the Board, the BioNJ Team, our members and partners across the State, I look forward to championing BioNJ's strategic priorities, advancing the life sciences innovation ecosystem, supporting the creation and retention of high-quality jobs and strengthening collaboration across industry, government and academia. By bringing people together around shared goals, we can ensure New Jersey remains a global leader in life sciences innovation ― bringing new, life-saving medicines to Patients around the world." Newly elected to the Board are Mary Elizabeth Blake, MBA, MPH, Chief Corporate Affairs Officer, Amicus Therapeutics; Kevin Hamill, President, Immunology, Johnson & Johnson Innovative Medicine; Christine Kingsbury, MBA, Vice President & Head , U.S. Marketing, Ascendis Pharma; Allyson McMillan-Youngblood, Senior Vice President & Head, Rare Disease Franchise, Acadia Pharmaceuticals; and Martin Whalen, MBA, Senior Vice President, Global Policy & Government Affairs, Bristol Myers Squibb. The following Board Members were re-elected for another two-year term: Alexandra Gruener, Senior Vice President, US Bladder Cancer & Oncology Portfolio Marketing Lead, Pfizer; Matthew B. Klein, M.D., M.S., FACS, CEO, PTC Therapeutics; and Robert Zamboldi, MBA, Site Head, Real Estate & Facility Services, Novartis. Bios for Newly Elected Board Members: Mary Elizabeth Blake, MBA, MPH, Chief Corporate Affairs Officer, Amicus Therapeutics Ms. Blake serves as the Chief Corporate Affairs Officer where she leads communications and policy globally. Previously, she was with Merck & Co. for 30 years, most recently as Vice President, Global Communications. There, she led communications for Merck's global, $50 billion human health business. Ms. Blake has broad experience across therapeutic areas in U.S. and global health, including rare disease, oncology, infectious diseases and vaccines. She is an accomplished corporate affairs leader with expertise in corporate and executive communications, brand and reputation management, product launches, public policy, business-driving product and scientific communications, crisis management, financial/M&A communications, corporate responsibility and leading organizational and cultural change. Kevin Hamill, President, Immunology, Johnson & Johnson Innovative Medicine Mr. Hamill leads the U.S. Immunology business at Johnson & Johnson Innovative Medicine, responsible for unlocking its new era of innovation and growth. He is focused on maximizing the portfolio, ensuring competitiveness of the business and brands, and preparing for future launches in gastroenterology, psoriatic and autoantibody diseases. Mr. Hamill's strong personal drive and deep expertise are invaluable in building on the organization's long legacy of pioneering innovation in immune-mediated inflammatory disease. His background includes leadership roles and experience in primary care, specialty care, biosimilars, ultra-orphan products, lifecycle planning, mature brand management, market access and business development at Johnson & Johnson and AstraZeneca. Mr. Hamill places a strong focus on developing talent, fostering a culture where people can excel and emphasizing the importance of executional excellence for reaching more Patients. Christine Kingsbury, MBA , Vice President & Head, U.S. Marketing , Ascendis Pharma Ms. Kingsbury is a senior biopharmaceutical executive with more than two decades of experience leading commercial strategy for rare disease franchises, and driving organizational impact across global pharma, biotech and consulting. She is recognized for her collaborative, mission-driven leadership and deep commitment to the Patient experience. At Ascendis Pharma, Ms. Kingsbury oversees the multi‑brand U.S. portfolio, providing strategic leadership for enterprise‑level strategy development, U.S. launch readiness, lifecycle planning and cross‑functional collaboration across commercial, medical and regulatory teams. She plays a leadership role in advancing Ascendis Pharma's rare disease franchises and driving commercial performance in fast-evolving therapeutic areas. Previously, Ms. Kingsbury led rare disease launches at Recordati Rare Diseases, achieving sustained growth while strengthening the commercial model and deepening engagement with Patient advocacy groups, global partners and key opinion leaders. Allyson McMillan-Youngblood, Senior Vice President & Head, Rare Disease Franchise, Acadia Pharmaceuticals Ms. McMillan-Youngblood leads commercial strategy for innovative therapies addressing significant unmet Patient needs. She brings more than 20 years of experience in the global pharmaceutical industry, with leadership roles across sales, marketing and franchise management in therapeutic areas, including oncology, immunology and cardiovascular/metabolic disease. Prior to Acadia, Ms. McMillan-Youngblood served as Senior Vice President and Head of U.S. Oncology at Bristol Myers Squibb, where she led a complex, multi-brand portfolio and drove sustained market leadership. She has professional experience in several industries beyond pharmaceuticals that include medical devices and consumer package goods. Ms. McMillan-Youngblood is committed to advancing mission-driven initiatives and supporting community-based organizations, with a particular focus on expanding opportunity for underserved communities. Martin Whalen, MBA, Senior Vice President, Global Policy & Government Affairs, Bristol Myers Squibb Mr. Whalen oversees BMS's government affairs function and leads the development of its global policy strategy, playing a pivotal role in advancing the company's objectives within an increasing complex global landscape. Previously, Mr. Whalen served in Stockholm as General Manager for BMS's European Union Cluster, overseeing the full portfolio and business operations across 15 countries. Since joining the organization in 2014, Mr. Whalen has held various commercial roles spanning market access, marketing and sales, with a strong focus on Oncology and Hematology. Throughout his tenure, he has successfully led the launch and expansion of numerous medicines and indications. Prior to this, Mr. Whalen spent 17 years at Pfizer, beginning in sales and advancing through commercial roles in managed care, marketing and general management. The complete 2026 Board of Trustees is as follows: ( Click here for full bios for BioNJ's Board Members.) Officers: Chair Christopher Cozic, Executive Vice President & Chief People Officer, Genmab; Immediate Past Chair Emer Leahy, Ph.D., MBA, President & CEO, PsychoGenics; Vice Chair Michael Schoen, Senior Vice President, Head, Government Affairs & Special Assistant to the CEO, BeOne Medicines; Debbie Hart, President & CEO, BioNJ; Treasurer Christopher Mortko, Ph.D., MBA, Vice President & Head, HQ Search & Evaluation, Merck Corporate Licensing; and Secretary Susan L. Levinson, Ph.D., CEO, BioAegis Therapeutics. Board Members: Sol J. Barer, Ph.D., former Chair & CEO, Celgene Corporation & Chair of the Board, Teva Pharmaceutical; Mary Elizabeth Blake, MBA, MPH, Chief Corporate Affairs Officer, Amicus Therapeutics; Carrie Brown, Head, U.S. Communications, Sanofi; Alexandra Gruener, Senior Vice President, US Bladder Cancer & Oncology Portfolio Marketing Lead, Pfizer; Kevin Hamill, President, Immunology, Johnson & Johnson Innovative Medicine; Christine Kingsbury, MBA, Vice President & Head , U.S. Marketing, Ascendis Pharma; Matthew B. Klein, M.D., M.S., FACS, CEO, PTC Therapeutics; John Maki, CEO, Serotonix; Anthony S. Marucci, MBA, Founder, President, CEO & Director, Celldex Therapeutics; Allyson McMillan-Youngblood, Senior Vice President & Head, Rare Disease Franchise, Acadia Pharmaceuticals; Scott Megaffin, President & CEO, Adiso Therapeutics; Brent Ragans, President, Ferring Pharmaceuticals; Christopher J. Schaber, Ph.D., Chair, President & CEO, Soligenix; Sonia Sequeira, Ph.D., CEO, VITRUVIAE; Martin Whalen, MBA, Senior Vice President, Global Policy & Government Affairs , Bristol Myers Squibb; and Robert Zamboldi, MBA, Site Head, Real Estate & Facility Services, Novartis. About BioNJ For more than 33 years, BioNJ, the State's largest and most influential life sciences trade association, has represented over 400 research-based organizations across the healthcare ecosystem — from the world's leading biopharmaceutical companies to early-stage start-ups — while championing Patients and advancing New Jersey's renowned life sciences industry. Because Patients Can't Wait®, BioNJ is dedicated to ensuring a vibrant life sciences community where Science is Supported, Companies are Created, Drugs are Developed and Patient Access to Lifesaving Medicines is Protected. As a respected thought leader and sought-after convener of the life sciences community, BioNJ works with policymakers in Trenton and Washington, D.C., to advance the industry, foster medical innovation, and promote healthcare affordability. With innovation as the driving force behind medical breakthroughs, BioNJ's mission is to help our Members help Patients by providing transformative resources, including access to government and industry leaders, capital and State incentives, timely educational programs, skilled talent and a value-driven purchasing program. For more information about BioNJ, please visit . Contact Randi Bromberg Sr. Vice President, Communications and Marketing O) 609-890-3185 C) 609-955-1067 [email protected] SOURCE BioNJ 21% more press release views with Request a Demo

First and Only CD19-Targeted Therapy Approved in Europe for Adults with anti-AChR+ and anti-MuSK+ gMG UPLIZNA Demonstrates Durable Disease Control with Twice-Yearly Dosing* THOUSAND OAKS, Calif., Feb. 12, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the European Commission (EC) has approved UPLIZNA® (inebilizumab) as an add-on treatment to standard therapy for adults living with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. The approval offers patients a new, targeted treatment option with the potential for long-term disease control through twice-yearly maintenance dosing, following two initial loading doses. Generalized myasthenia gravis is a rare, unpredictable, chronic, B-cell-mediated autoimmune disease that causes fluctuating muscle weakness and can impact quality of life.1-3 It is a subtype of myasthenia gravis (MG), which affects an estimated 56,000-123,000 people in Europe.4 "This approval represents an important advancement for adults with gMG in Europe, helping address debilitating symptoms and potentially reduce the long-term use of steroids where clinically appropriate," said Cesar Sanz Rodriguez, vice president of Medical Affairs at Amgen. "With convenient twice-yearly dosing and durable efficacy in people with anti‑AChR and anti‑MuSK antibody positive gMG, UPLIZNA brings a new first-in-class approach to managing this complex disease." The EC approval is supported by data from the Myasthenia Gravis Inebilizumab Trial (MINT), the largest Phase 3 biologic study to include both AChR+ and MuSK+ patients, and the first to successfully incorporate a structured steroid-tapering protocol. Patients receiving steroids at baseline began tapering at Week 4 with a goal of reaching prednisone 5 mg per day by Week 24. By Week 26, 87.4% of patients taking UPLIZNA and 84.6% of those taking placebo had reduced their steroid dose to 5 mg or less per day.5 "UPLIZNA offers a new approach to treating gMG by selectively targeting CD19-positive B cells, which play a key role in disease pathology," said John Vissing, MD, DMSci, professor of neurology and director of the Copenhagen Neuromuscular Center, Rigshospitalet, at the University of Copenhagen. "The approval provides both clinicians and patients a valuable new treatment option with the potential for long-term efficacy while addressing the challenges of long-term steroid exposure." The approval in gMG builds on UPLIZNA's established efficacy in rare autoimmune conditions, including its November 2025 EC approval as the first and only treatment for adults living with active immunoglobulin G4-related disease (IgG4-RD),6 a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs.7,8 UPLIZNA was also previously approved as a monotherapy for adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.6 UPLIZNA has received regulatory approvals across multiple indications from the U.S. Food and Drug Administration, Health Canada, and the Brazilian Health Regulatory Agency (ANVISA), among others. About the MINT Trial MINT is a randomized, double-blind, placebo-controlled, parallel-group trial (NCT04524273) designed to evaluate the efficacy and safety of UPLIZNA in adults with gMG. The trial enrolled 238 adults with gMG, including 190 patients who are AChR+ and 48 patients who are MuSK+.5 Eligibility criteria at screening and randomization included a Myasthenia Gravis Foundation of America (MGFA) classification of II, III or IV disease, MG-ADL score between 6 and 10 with greater than 50% of this score attributed to non-ocular items, or an MG-ADL score of at least 11, and a Quantitative Myasthenia Gravis (QMG) score of at least 11.5 Participants had to have been receiving a stable dose of steroids and/or nonsteroidal immunosuppressive therapy (or both) at the time of randomization.5 The primary endpoint was change from baseline in MG-ADL score at Week 26 in the combined study population.5 Key secondary endpoints included change from baseline in QMG scores in the combined study population; change from baseline in MG-ADL score at Week 26 for the AChR+ cohort and separately the MuSK+ cohort; and change from baseline in QMG score at Week 26 for the AChR+ cohort and separately the MuSK+ cohort.5 MINT also includes an optional three-year open-label treatment period. Key findings from MINT include5: Primary Endpoint: A 1.9-point difference in the MG-ADL score for UPLIZNA (-4.2) compared to placebo (-2.2) (p<0.0001) at Week 26 for the combined study population. Key Secondary Endpoints: A 2.5-point difference in the QMG score for UPLIZNA (-4.8) compared to placebo (-2.3) (p=0.0002) at Week 26 for the combined treated population. A 1.8-point difference in the MG-ADL score for UPLIZNA (-4.2) compared to placebo (-2.4) (p=0.0015) at Week 26 for the AChR+ population. A 2.5-point difference in the QMG score for UPLIZNA (-4.4) compared to placebo (-2.0) (p=0.0011) at Week 26 for the AChR+ population. A 2.2-point difference in the MG-ADL score for UPLIZNA (-3.9) compared to placebo (-1.7) (p=0.0297) at Week 26 for the MuSK+ population. A 2.3-point difference in the QMG score for UPLIZNA (-5.2) compared to placebo (-3.0) (p=0.1326) at Week 26 for the MuSK+ population; this difference was not statistically significant. Additional Exploratory Endpoints: A 2.8-point difference (95% CI: −3.9 to −1.7) in the MG-ADL score for UPLIZNA (-4.7) compared with placebo (-1.9) at Week 52 for the AChR+ population. A 4.3-point difference (95% CI: −5.9 to −2.8) in the QMG score for UPLIZNA (-5.8) compared with placebo (-1.4) at Week 52 for the AChR+ population. 87.4% of UPLIZNA patients and 84.6% of those taking placebo reduced their steroid dose to 5 mg or less per day by Week 26. MG-ADL scale, which assesses the impact of gMG on daily functions of 8 signs or symptoms that are typically affected in gMG. Each item is assessed on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. The total MG-ADL score ranges from 0 to 24, with higher scores indicating more impairment. The QMG score is a 13-item categorical grading system that quantitively measures disease impairment by mainly assessing muscle weakness. Each item is assessed on a 4-point scale where a score of 0 represents no impairment weakness and a score of 3 represents severe impairment weakness. A total possible score ranges from 0 to 39, where higher scores indicate more severe impairment. About Generalized Myasthenia Gravis (gMG) Generalized myasthenia gravis (gMG) is a rare, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause muscle weakness, trouble breathing, difficulty swallowing and impaired speech and vision.1-3 Approximately 85% of patients with myasthenia gravis have the generalized form, or gMG.9,10 The prevalence and incidence of gMG are increasing worldwide.10 There are an estimated 56,000 to 123,000 people with myasthenia gravis in Europe, with prevalence rates in different countries varying significantly.4 Approximately 85% of patients with myasthenia gravis have detectable antibodies against AChR, and approximately 7% have detectable antibodies against MuSK.11 Global prevalence is estimated at 2-36 cases per 100,000.4 The disease is more frequently seen in young women (age 20-30) and men aged 50 years and older.4,10 B cells are central to the pathogenesis of gMG. The disease is thought to be primarily driven by pathogenic CD19+ plasmablasts and plasma cells that target critical proteins in the neuromuscular junction.1-3 About UPLIZNA® (inebilizumab) UPLIZNA is a humanized monoclonal antibody (mAb) that causes targeted and sustained depletion of key cells that contribute to the underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). The precise mechanism by which UPLIZNA exerts its therapeutic effects is unknown. After two initial infusions, patients need one maintenance dose of UPLIZNA every six months. 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, heart disease, inflammatory conditions, rare diseases 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. Amgen 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. or Kyowa Kirin Co., 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. 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. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. 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. 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, 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. CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media) Annik Allen, 917-288-9136 (media) Casey Capparelli, 805-447-1746 (investors) References *After two initial loading doses. Yi JS, Guptill JT, Stathopoulos P, Nowak RJ, O'Connor KC. B cells in the pathophysiology of myasthenia gravis. Muscle Nerve. 2018;57(2):172-184. Willcox HN, Newsom-Davis J, Calder LR. Cell types required for anti-acetylcholine receptor antibody synthesis by cultured thymocytes and blood lymphocytes in myasthenia gravis. Clin Exp Immunol. 1984;58:97-106. Stathopoulos P, Kumar A, Nowak RJ, O'Connor KC. Autoantibody-producing plasmablasts after B cell depletion identified in muscle-specific kinase myasthenia gravis. JCI Insight. 2017;2(17):e94263. Bubuioc AM, Kudebayeva A, Turuspekova S, Lisnic V, Leone MA. The epidemiology of myasthenia gravis. J Med Life. 2021;14(1):7-16. Nowak R, Benatar M, Ciafaloni E, et al. A phase 3 trial of inebilizumab in generalized myasthenia gravis. N Engl J Med. 2025;392(23):2309-2320. European Medicines Agency. First treatment recommended for rare immunoglobulin-related autoimmune disease. Available at: . Accessed: February 2026. Stone JH, Khosroshahi A, Zhang W, et al. Inebilizumab for Treatment of IgG4-Related Disease. N Engl J Med. 2025;392(12):1168-1177. Perugino CA, Stone JH. IgG4-related disease: an update on pathophysiology and implications for clinical care. Nat Rev Rheumatol. 2020;16(12):702-714. Lazaridis K, Tzartos SJ. Autoantibody specificities in myasthenia gravis: implications for improved diagnostics and therapeutics. Front Immunol. 2020;11:212. Dresser L, Wlodarski R, Rezania K, Soliven B. Myasthenia gravis: epidemiology, pathophysiology and clinical manifestations. J Clin Med. 2021;10(11):2235. Hehir MK, Silvestri NJ. Generalized myasthenia gravis: classification, clinical presentation, natural history, and epidemiology. Neurol Clin. 2018;36:253-260. Logo - 21% more press release views with Request a Demo