pdufa.bio
HomeDecisions › GILD 2026-05-26

GILD FDA decision — May 26, 2026

✓ APPROVED

Gilead Sciences Inc. — Hepcludex (Bulevirtide) - (MYR301) · Hepatitis delta virus (HDV).

Run-up into the decision (T-120 → T+5)

PDUFA 5/26/26$155.8$118.312/9/25
Daily close, T-120 (12/9/25) through T+5. Run-up high $155.8 on 2/16/26, low $118.3 on 1/9/26 (T-120 to T-1). FDA decision 5/26/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-05-26
OutcomeApproved
Drug / candidateHepcludex (Bulevirtide) - (MYR301)
CompanyGilead Sciences Inc.
120-day run-up (T-120→T-1)+8.1%