The U.S. Food and Drug Administration has lifted the partial clinical hold order on Gilead Sciences, Inc.’s (GILD) blood cancer drug combination trials. The hold was initially placed on five trials in January 2022.
FDA revoked the hold after conducting a review of safety data from each trial. Now that the partial hold has been lifted, Gilead can start taking participants in the U.S. to check the efficacy of magrolimab in combination with azacitidine in treating myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).
Further, the company will begin enrollment for the magrolimab studies that were placed on a voluntary hold outside of the U.S. However, the FDA is yet to revoke the partial clinical hold on studies evaluating magrolimab in diffuse large B-cell lymphoma and multiple myeloma.
Gilead also informed the public that despite the clinical hold, patients already enrolled in the magrolimab studies continued to be treated. Moreover, since the company had reached a satisfactory enrollment threshold for one of the studies, Phase 3 ENHANCE study, it expects to report the first interim analysis as scheduled in 2023.
Merdad Parsey, MD, PhD, Chief Medical Officer at Gilead Sciences, said, “This is a significant milestone for Gilead and, more importantly, for patients diagnosed with these cancers. We look forward to continuing our work developing magrolimab and advancing this potential cancer treatment option.”
Analyst Recommendation
RBC Capital analyst Brian Abrahams maintained a Buy rating on Gilead with a price target of $77, implying 24.4% upside potential from current levels.
The rest of the Street is cautiously optimistic about the stock, with a Moderate Buy consensus rating based on eight Buys, nine Holds, and one Sell. The average Gilead price forecast of $70.59 implies 14% upside potential from current levels.
Hedge Fund Trading Activity
TipRanks’ Hedge Fund Trading Activity tool shows that confidence in Gilead is currently Very Negative, as hedge funds cumulatively sold 3.4 million shares of the stock in the last quarter.
Takeaway
Shares of Gilead have dropped almost 15% so far this year. Faltering confidence of hedge funds and involvement in legal issues might continue to weigh on Gilead stock. However, positive news on these trials and encouraging performance in the upcoming quarterly release may help woo investors.
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