Gilead Sciences acquires our drug for first-in-progress T cell engagement program for autoimmune diseases

FOSTER CITY, Calif.–( BUSINESS WIRE )–Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has entered into a definitive agreement to acquire Oro Pharmaceuticals, a privately held biotechnology company focused on developing T cell-mediated therapies for autoimmune diseases.

“This acquisition underscores our commitment to developing transformative therapies for people living with serious autoimmune diseases,” said Dietmar Berger, MD, PhD, Gilead’s chief medical officer.

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The acquisition adds OM336 (gamgertamig), a clinical-stage BCMAxCD3 T cell inhibitor, to Gilead’s growing inflammatory portfolio. OM336 is designed to induce rapid and profound B cell depletion after a limited subcutaneously administered treatment course. In ongoing Phase 1/2 clinical studies, OM336 has demonstrated a reversible efficacy and distinct safety profile after one cycle of treatment in antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the US FDA for the treatment of AIHA and ITP and is expected to enter registration studies in 2027.

“This acquisition underscores our commitment to developing transformative therapies for people living with serious autoimmune diseases,” said Dietmar Berger, MD, PhD, Gilead’s chief medical officer. “BCMA is a validated target with emerging data showing potentially transformative outcomes in autoimmune diseases. BCMA-targeted T cell inhibitors offer a differentiated approach with the potential to promote sustainable disease control. This new framework complements our expanding inflammation pipeline and reflects our strategy to invest in innovative standard science that may advance care.”

BCMA-targeted T cell activators are being investigated as a precise approach to acute inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. By transferring a patient’s own T cells to BCMA-expressing plasma cells, clinical data suggest that these agents may reduce inflammation, improve organ-level disease, and, in some cases, activate immune reconstitution marked by sustained, drug-free immunity without persistent immunosuppression. T cell attractors represent an important model for patients with Gilead’s portfolio of CAR-T assets.

“From the beginning, we saw the potential of gamagratamig to redefine the standard of care for immune-mediated diseases,” said Jaideep Dodhani, Ph.D., co-founder and CEO of Overo Medicines. “Since then, we have taken meaningful steps to advance this vision, with multiple trials now underway. With the support of Gilead and Galapagos, we can build on a strong early foundation – leveraging a proven track record in late-stage development, launch, and commercialization to accelerate our programs and help deliver on the promise of keeping gamgertamig for patients with early-onset disease. Bioscience.”

Terms of Transaction

Under the terms of the agreement, Gilead will acquire all Oro Pharmaceuticals outstanding for an upfront cash consideration of $1,675 million, subject to customary adjustments, payable at closing, and up to $500 million in milestone payments. The closing of the transaction is subject to the expiration or termination of certain regulatory filings and other customary conditions.

Strategic cooperation with Galapagos

Gilead is currently in advanced discussions with Galapagos regarding a potential research and development collaboration on the acquired Oro Pharmaceutical assets. The arrangement between Gilead and Galapagos is thought to include the following key terms:

  • Galapagos will pay 50% of the advance care and 50% of any milestone payments payable to Oro Pharmaceuticals shareholders.

  • Galapagos will absorb substantially all of Oro Pharmaceuticals’ operating assets and retain its employees.

  • Gilead and Galapagos will collaborate on the development of OM336, with Galapagos responsible for development costs through initiation of registration studies. The costs of the registration study will be shared equally between the parties.

  • Gilead will retain exclusive worldwide commercialization rights (except in Greater China where Chemed Biosciences has commercialization rights) and Gilead will pay Galapagos royalties of 20%-23% of net sales.

  • Amended Legacy Galapagos Option License and Cooperation Agreement (“OLCA”) to allow up to $500 million of Galapagos’ current cash to be freely used by Galapagos, including up to $150 million for potential share repurchases.

Centreview Partners LLC and TD Cowen are acting as financial advisors to Gilead. Goldman Sachs & Co. LLC serves as the exclusive financial advisor to Oro Pharmaceuticals. Morgan Stanley & Company, LLC is acting as financial advisor to Galapagos. Covington & Burling LLP, Mayer Brown LLP, and Arnold & Porter Kaye Scholer LLP are serving as legal counsel to Gilead. Goodwin Procter LLP is acting as legal counsel for our pharmaceuticals. Paul Weiss LLP and Linklaters LLP are serving as legal counsel to Galapagos.

About OM336

OM336 is an investigational BCMAxCD3-specific T cell engineered for the treatment of autoantibodies in immune-mediated diseases. OM336 has been granted Orphan Drug Designation and Fast Track Designation by the US Food and Drug Administration for certain autoimmune diseases. OM336 is under open IND in the US and is expected to enter registration studies in 2027. OM336 is licensed by Oro Pharmaceuticals from Klima Biosciences, which has the rights to develop this program in Greater China.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades with the goal of creating a healthier world for all. The company is committed to developing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

About fire medicine

Oro Pharmaceuticals is a clinical-stage biotechnology company dedicated to developing immune-reset therapies for people living with immune-mediated diseases. Oro’s approach focuses on exploiting T cell involvement in B cell-mediated diseases to achieve an immune reset that produces persistent immunity without permanent immunity. Based in San Francisco and launched in 2025, Oro was founded by Monograph Capital in partnership with GSK. Oro is also backed by leading investors TPG, NEA and Norvest. For more information visit www.ouromedicines.com or follow us on LinkedIn.

Gilead Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Filing Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Oro Pharmaceuticals to complete the acquisition transaction on time or at all; the possibility that various closing conditions to the acquisition transaction may not be satisfied or waived, including the possibility that a government agency may withhold, delay or refuse to grant approval for the consummation of the acquisition transaction; uncertainties related to the timing or outcome of any filings and approvals related to the acquisition transaction; Gilead’s ability to negotiate and enter into the proposed collaboration with Galapagos, including on the terms described herein and on a timely basis or at all; difficulties or unexpected costs in connection with the merger of the companies, including the impact of the acquisition transaction and the proposed cooperation with regard to relations with employees, other business partners or government agencies; The risk that Gilead may not realize the expected benefits of this acquisition transaction. Gilead’s ability to develop its product pipeline and successfully commercialize product candidates following the acquisition; the ability of the parties to initiate and complete clinical trials involving the same product candidate on the currently estimated schedule or at all; the possibility of unfavorable results from one or more such trials involving the same product candidate; uncertainties related to regulatory applications and related filing and approval schedules, including the risk that the FDA may not approve such product candidates in the expected indications or timelines or at all, and any marketing approvals, if granted, may have significant limitations on their use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2025. As filed with the United States Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those indicated in the forward-looking statements. All statements other than statements of historical fact are statements that may be considered forward-looking statements. The reader is cautioned that any forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intention to update such forward-looking statements.

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