Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
Hepcludex (Bulevirtide) was approved by the FDA on May 22, 2026 to treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis, the 16th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
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%
FDA record of the action: the FDA approved on May 22, 2026, per BLA 761468 ORIG-1 (FDA letter). The sponsor announced it on May 26, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Questions
Was Hepcludex (Bulevirtide) approved by the FDA?
Yes. The FDA approved the application for Hepcludex (Bulevirtide) on May 22, 2026, per the FDA's own record. The company announced it on May 26, 2026. The primary source is linked on this page.
Which company is behind Hepcludex (Bulevirtide)?
Hepcludex (Bulevirtide) is a Gilead Sciences Inc. (GILD) program. The FDA decision came on May 22, 2026; the FDA's own record of the decision is linked on this page.
How did GILD stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), GILD moved +8.1%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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