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Gilead (GILD) HIV Candidate Gets Positive CHMP Recommendation

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Gilead Sciences, Inc. GILD has announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency adopted a positive opinion for pipeline candidate lenacapavir.

Lenacapavir is Gilead’s potential first-in-class, investigational long-acting HIV-1 capsid inhibitor in development for the treatment of HIV-1 infection.

Gilead is seeking the European Commission’s (“EC”) approval of the candidate for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen.

The positive opinion is supported by data from the phase II/III CAPELLA trial, a double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of lenacapavir administered every six months as a subcutaneous injection, in combination with other antiretroviral(s), in heavily treatment-experienced people with multi-drug resistant HIV-1 infection.

We note that the EC generally takes CHMP opinion into account but is not bound by it.

Per the company, if authorized, lenacapavir could offer a new, every six-month treatment option for people with limited treatment choices.

A potential approval will strengthen Gilead’s HIV approval.

The stock has lost 12.7% so far in the year compared with the industry's decline of 21.7%.

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Earlier in the month, the FDA lifted the clinical hold placed on its investigational new drug application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP).

We note that the HIV franchise is the lead growth driver for Gilead propelled by the solid uptake of Biktravy.

Concurrently, Gilead is making efforts to develop its oncology business to diversify its revenue base as competition is stiff in the HIV business from the likes of GlaxoSmithKline GSK. Also, the loss of exclusivity for Truvada has hurt the company’s business.

Glaxo’s HIV franchise recorded 14% growth in the quarter.  Growth was driven by new HIV products Dovato, Cabenuva, Rukobia, Juluca and Apretude and phasing.

Gilead currently carries a Zacks Rank #3 (Hold).  A couple of better-ranked stocks are Alkermes ALKS and Geron Corporation GERN. While Alkermes sports a Zacks Rank #1 (Strong Buy), Geron has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Loss estimates for ALKS for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed estimates in all of the trailing four quarters, the average surprise being 350.48%.

Loss estimates for GERN for 2022 have narrowed by 6 cents in the past 60 days. Geron surpassed estimates in three of the trailing four quarters, the average surprise being 1.07%.




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