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15 Jun 2026, 20:34 UTC · 2h ago

U.S. FDA Accepts Gilead's Application for Investigational Once-Weekly Oral Yeztugo, Potentially the First Long-Acting Pill for HIV Prevention

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U.S. FDA Accepts Gilead's Application for Investigational Once-Weekly Oral Yeztugo, Potentially the First Long-Acting Pill for HIV Prevention

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2 claims · each scored for market impact

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1
The FDA has accepted Gilead's supplemental New Drug Application (sNDA) for Yeztugo (lenacapavir) as a once-weekly oral PrEP for HIV prevention. — FDA acceptance is a critical regulatory milestone for a potential high-revenue product, though final approval is not yet guaranteed.
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2
The FDA has assigned a PDUFA action date of February 2, 2027, for the Yeztugo application. — The distant 2027 timeline delays potential revenue realization and market entry for this specific formulation.
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The FDA accepted a supplemental New Drug Application for a new oral HIV prevention formulation, representing a positive regulatory milestone.

Read original · https://www.businesswire.com/news/home/20260615875061/en/U.S.-FDA-Accepts-Gilead%E2%80%99s-Application-for-Investigational-Once-Weekly-Oral-Yeztugo-Potentially-the-First-Long-Acting-Pill-for-HIV-Prevention/

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U.S. FDA Accepts Gilead's… — GILD +0.80 | NewsImpactScreener

U.S. FDA Accepts Gilead's Application for Investigational Once-Weekly Oral Yeztugo, Potentially the First Long-Acting Pill for HIV Prevention

What matters in this story

How each ticker is affected

Lexeo Therapeutics, Inc. (LXEO) Shareholder/Analyst Call Transcript

U.S. FDA Accepts Gilead's Application for Investigational Once-Weekly Oral Yeztugo, Potentially the First Long-Acting Pill for HIV Prevention

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Lexeo Therapeutics, Inc. (LXEO) Shareholder/Analyst Call Transcript

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U.S. FDA Accepts Gilead's Application for Investigational Once-Weekly Oral Yeztugo, Potentially the First Long-Acting Pill for HIV Prevention

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Lexeo Therapeutics, Inc. (LXEO) Shareholder/Analyst Call Transcript

U.S. FDA Accepts Gilead's Application for Investigational Once-Weekly Oral Yeztugo, Potentially the First Long-Acting Pill for HIV Prevention

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Lexeo Therapeutics, Inc. (LXEO) Shareholder/Analyst Call Transcript

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