FDA Puts Gilead’s Lenacapavir Injection on Clinical Hold

Gilead Sciences, Inc. (GILD) revealed that the U.S. Food and Drug Administration has put the use of lenacapavir injection, designed to treat HIV, on clinical hold. However, oral dosage of lenacapavir will continue.

The hold has been placed on the grounds of rising concerns about the compatibility of vials made of borosilicate glass with lenacapavir solution. The combination is said to create sub-visible glass particles in the solution of lenacapavir.

As a result of this move, the company will not be able to screen and enroll study participants or use the injection across all lenacapavir studies. Gilead seeks to solve the vial quality hurdle and remains optimistic about its future potential.

Chief Medical Officer of Gilead Sciences, Merdad Parsey, MD, PhD, said, “We are committed to working diligently with FDA to resolve this glass vial compatibility quality issue and resume injectable lenacapavir dosing in the affected studies in a timely fashion.”

Wall Street’s View

Last week, BMO Capital analyst Evan Seigerman maintained a Buy rating on the stock with a price target to $85 (18.3% upside potential). 

Meanwhile, the Street is cautiously optimistic about the stock and has a Moderate Buy consensus rating, based on 10 Buys and 6 Holds. The Gilead stock price prediction of $77.62 implies 8.1% upside potential.

Increased Hedge Fund Activity

TipRanks’ Hedge Fund Trading Activity tool shows that confidence in Gilead is currently Very Positive, as the cumulative change in holdings across all 12 hedge funds that were active in the last quarter was an increase of 8.2 million shares.

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