03:21 PM EDT, 06/18/2025 (MT Newswires) -- Gilead Sciences ( GILD ) said Wednesday the US Food and Drug Administration approved Yeztugo, its twice-yearly injectable for HIV prevention.

The approval, granted under priority review, makes Yeztugo the first FDA-approved pre-exposure prophylaxis option in the US administered every six months, the company said.

The subcutaneous treatment showed high efficacy and a consistent safety profile in phase 3, Purpose 1 and 2 trials, with about 99.9% of participants remaining HIV negative.

Gilead said it is working to ensure broad insurance coverage for Yeztugo in the US and has submitted or is preparing regulatory filings in markets including Europe, Canada, Latin America, Australia, and South Africa.

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