GILD · 8-K · 20260804PR000028
Regulatory Approval Milestones
GILEAD SCIENCES, INC. · 2026-08-04 · Importance 31 · Surprise 42 · In source text
The U.S. FDA accepted Gilead's supplemental New Drug Application for a potential once-weekly oral Yeztugo formulation for HIV PrEP, with a Prescription Drug User Fee Act target action date of February 2, 2027. The FDA granted accelerated approval for Hepcludex in adults with chronic HDV infection without cirrhosis or with compensated cirrhosis, making it the first FDA-approved HDV treatment in the United States. The FDA also approved Trodelvy for first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer under specified PD-1/PD-L1 eligibility conditions. The European Commission authorized Trodelvy as monotherapy for previously untreated metastatic triple-negative breast cancer, and the European Medicines Agency's committee issued a positive opinion for Trodelvy in combination with Keytruda in PD-L1-expressing tumors.
Key facts
- Gilead announced FDA acceptance of a supplemental NDA for Yeztugo 300-mg tablets for once-weekly oral PrEP with a PDUFA target action date of February 2, 2027 source
- Received FDA accelerated approval for Hepcludex for treatment of chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis, which is the first and only FDA-approved treatment for HDV in the U.S. source
- Received FDA approval of Trodelvy for first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer with specified single-agent and combination indications source
- Announced European Commission marketing authorization for Trodelvy as monotherapy for adult patients with unresectable locally advanced or mTNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1/PD-L1 inhibitor therapy source
- Three FDA approvals and three positive Phase 3 updates were achieved in the period referenced in the press release source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | Gilead announced FDA acceptance of a supplemental NDA for Yeztugo 300-mg tablets for once-weekly oral PrEP with a PDUFA target action date… |
| revenue | positive | probable | — | Received FDA accelerated approval for Hepcludex for treatment of chronic hepatitis delta virus infection in adults without cirrhosis or… |
| revenue | positive | probable | — | Received FDA approval of Trodelvy for first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer… |
| revenue | positive | probable | — | Announced European Commission marketing authorization for Trodelvy as monotherapy for adult patients with unresectable locally advanced or… |