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Gilead Statement on Magrolimab Studies in Solid Tumors

Foster City, Calif., February 15, 2024 – Gilead Sciences, Inc. today announced that it has paused enrollment globally in the magrolimab solid tumor studies.  The U.S. Food and Drug Administration (FDA) subsequently requested a partial clinical hold on these trials. This request is in addition to the previously announced full clinical hold on all magrolimab studies in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) requested by the FDA.  Gilead is reviewing the benefit-risk of magrolimab across all ongoing trials and will provide an update on this assessment as soon as possible.

Patients already enrolled in the Gilead-sponsored ELEVATE solid tumor studies and deriving clinical benefit may continue to choose receiving magrolimab following reconsenting to the study with their healthcare provider.

The Gilead-sponsored ELEVATE solid tumor studies impacted by the partial clinical hold include:

  • Phase 2 study in head and neck squamous cell carcinoma (NCT04854499)
  • Phase 2 study in solid tumors (NCT04827576)
  • Phase 2 study in triple-negative breast cancer (NCT04958785)
  • Phase 2 study in colorectal cancer (NCT05330429)

The enrollment hold also applies to Investigator Sponsored Studies with magrolimab in solid tumors.

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 people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead Forward-Looking Statements
This statement includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional trials, including those involving magrolimab; uncertainties relating to regulatory applications and related filing and approval timelines including the risk that FDA may not remove the partial or full clinical holds placed on studies involving magrolimab; the possibility that Gilead may make a strategic decision to discontinue development of magrolimab and that, as a result, magrolimab may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such 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 intent to update any such forward-looking statements.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com, 
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1-650-574-3000.