Cantor Fitzgerald reiterates Overweight on Gilead Sciences

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Key Highlights

Cantor Fitzgerald analyst Carter Gould has reiterated an Overweight rating on Gilead Sciences, maintaining a price target of $155.

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Cantor Fitzgerald analyst Carter Gould has reaffirmed an Overweight rating for Gilead Sciences, maintaining a price target of $155. The reiteration signals continued confidence in the pharmaceutical company's stock performance.

The rating and price target were issued by Cantor Fitzgerald, covering Gilead Sciences (NASDAQ: GILD). The $155 target provides a reference point for investors regarding the stock's potential valuation.

Firm Analyst Rating Price Target
Cantor Fitzgerald Carter Gould Overweight $155
Disclaimer: This article is AI-generated using data from ViewTrade. ScanX is not liable for any inaccuracies.

What upcoming clinical trial results could significantly influence Gilead's stock performance?

How might recent regulatory changes impact Gilead's revenue projections?

What are the potential risks to achieving the $155 price target?

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Gilead seeks FDA approval for once-weekly oral HIV pill

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Reviewed by
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Key Highlights

Gilead Sciences announced that the FDA accepted its sNDA for Yeztugo (lenacapavir) 300-mg tablet as a once-weekly oral PrEP, setting a PDUFA action date of February 2, 2027. Supported by PURPOSE 1 and 2 trials, the investigational formulation aims to offer the first long-acting oral PrEP option. Chief Medical Officer Dietmar Berger highlighted the company's commitment to expanding HIV prevention options.

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Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for Yeztugo as a potential once-weekly oral formulation for HIV prevention. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027, to review the application for the 300-mg tablet used as pre-exposure prophylaxis (PrEP).

The submission is supported by the clinical profile of lenacapavir, the active ingredient in Yeztugo. Data from the PURPOSE 1 and PURPOSE 2 trials demonstrated high efficacy in HIV prevention across diverse populations, including cisgender women, cisgender men, and gender-diverse people. If approved, this once-weekly oral option could become the first long-acting oral PrEP available.

Dietmar Berger, Chief Medical Officer at Gilead Sciences, stated that the filing reflects the company's commitment to advancing new HIV prevention options. He noted that nearly one year after the approval of twice-yearly Yeztugo, the company aims to extend the impact of its long-acting innovation into new formulations to broaden how HIV prevention is delivered.

Currently, lenacapavir oral tablets are approved within the Yeztugo regimen as an initial loading dose and as bridge therapy when administration of the every-six-month injections is delayed. The once-weekly oral formulation for PrEP remains investigational and is not approved anywhere globally.

About Lenacapavir

Lenacapavir is approved in multiple countries as PrEP to reduce the risk of sexually acquired HIV in adults and adolescents at risk of acquisition. It is also approved for the treatment of multi-drug-resistant HIV in adults in combination with other antiretrovirals. The drug features a multi-stage mechanism of action designed to inhibit HIV at multiple stages of its lifecycle, with no known cross-resistance to other existing drug classes in vitro.

Feature Description
Current Approval PrEP and treatment of multi-drug-resistant HIV
Mechanism Multi-stage inhibition of HIV lifecycle
Investigational Use Once-weekly oral PrEP
Disclaimer: This article is AI-generated using data from ViewTrade. ScanX is not liable for any inaccuracies.

How might the introduction of a once-weekly oral PrEP option impact the current market dominance of daily oral pills and biannual injections?

What pricing strategies will Gilead likely employ to ensure broad accessibility for the weekly formulation compared to existing PrEP options?

Could the convenience of a weekly oral regimen significantly improve adherence rates among populations that struggle with daily or biannual dosing schedules?

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