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Gilead (GILD) Magrolimab Studies' Partial Clinical Hold Removed

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Gilead Sciences, Inc. (GILD - Free Report) recently announced that the FDA has lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with Vidaza.

Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor. It is being developed in several hematologic cancers, including myelodysplastic syndrome (MDS) and solid tumor malignancies.

The regulatory body decided to remove the hold following a review of the comprehensive safety data from each trial.

The FDA placed the hold in January 2022 due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms.

With the hold removed, Gilead can resume enrollment in the studies evaluating magrolimab in combination with Vidaza in MDS and acute myeloid leukemia (AML) in the United States

The company is also planning to re-open enrollment in the magrolimab studies placed on a voluntary hold outside of the United States. Gilead is also working with the FDA regarding the remaining partial clinical hold affecting studies evaluating magrolimab in diffuse large B-cell lymphoma and multiple myeloma. The ongoing clinical studies evaluating magrolimab in solid tumors were not subject to the clinical hold.

We remind investors that magrolimab was granted a Breakthrough Therapy designation for the treatment of newly diagnosed MDS by the FDA in 2020.

Patients enrolled in the affected magrolimab studies, including the late-stage ENHANCE study, continued receiving treatment during the hold tenure. Prior to the trial hold, Gilead had already met the pre-specified enrollment threshold required for the first interim analysis of the ENHANCE study. Gilead continues to expect a readout for the first interim analysis in 2023.

Gilead’s stock has lost 4.3% in the year so far compared with the industry's decline of 28.2%.

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The decline in its legacy HCV business and increasing competition in the HIV business propelled Gilead to diversify into the lucrative oncology space, which promises great potential despite fierce competition.

To that end, Gilead has made good progress of late.

Gilead entered into a collaboration and supply agreement with pharma giant Merck (MRK - Free Report) .

Gilead and Merck have collaborated to evaluate the combination of the former’s Trop-2 targeting antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) and the latter’s anti-PD-1 therapy Keytruda in the first-line setting in patients with metastatic TNBC and, in the first quarter 2022, in patients with non-small cell lung cancer.

Gilead’s HIV therapy Biktarvy continues to drive growth despite the ongoing impact of the pandemic, and the momentum should continue. However, the loss of exclusivity of Truvada and Atripla has affected the HIV franchise’s performance.

Competition is intense in the HIV market from GlaxoSmithKline (GSK - Free Report) and others. Glaxo has a strong HIV portfolio comprising Dovato, Juluca, Rukobia and Cabenuva.

Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is VistaGen Therapeutics (VTGN - Free Report) , which carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Loss estimates for VTGN have narrowed to 22 cents from 26 cents for 2022 in the past 60 days. Earnings of VistaGen surpassed estimates in two of the trailing four quarters and missed the same twice.


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