U.S. FDA Grants Priority Review of New Drug Application for Gilead’s Once-Daily HIV Treatment of Bictegravir Plus Lenacapavir
Gilead Sciences, Inc. (GILD)
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Source: Business Wire
– Novel Investigational Combination Pairs Bictegravir, Guideline-Recommended INSTI with High Barrier to Resistance, with Lenacapavir, a First-in-Class Capsid Inhibitor, Designed for Sustained Virologic Suppression for People Living with HIV –– If Approved, Combination will be Smallest Single-Tablet Regimen (STR) for HIV Treatment and First STR Studied in Adults with Virological Suppression on Complex Multi-Tablet Regimens – FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) – an investigational, once-daily single-tablet combination regimen for the treatment of HIV in adults who are virologically suppressed. The FDA has granted priority review of the application and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026.“This once-daily, single-tablet regimen brings together
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GILD
Earnings
- 2/10/26 - Beat
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Sec Filings
- 4/29/26 - Form SCHEDULE
- 4/29/26 - Form 4
- 4/28/26 - Form 144
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