GILD · 10-Q · 2026Q2 · Full report
Regulatory Approval Milestones
GILEAD SCIENCES, INC. · 2026-08-06 · Importance 47 · Surprise 60 · In source text
The FDA accepted Gilead’s supplemental NDA for a once-weekly oral Yeztugo formulation for HIV pre-exposure prophylaxis, with a PDUFA target action date of February 2, 2027. FDA also granted accelerated approval for Hepcludex, the first and only FDA-approved treatment for hepatitis delta virus in the United States. FDA accepted the bictegravir and lenacapavir NDA under priority review, with a PDUFA target action date of August 27, 2026, while Trodelvy received FDA approval for first-line locally advanced or metastatic triple-negative breast cancer. The European Medicines Agency issued a positive opinion and the European Commission granted marketing authorization for specified first-line Trodelvy uses, and FDA granted full approval for Tecartus in relapsed or refractory mantle cell lymphoma.
Key facts
- FDA accepted a supplemental NDA for Yeztugo 300-mg tablet with a PDUFA target action date of February 2, 2027. source
- FDA accepted an NDA for bictegravir and lenacapavir for virologically suppressed people with HIV under priority review with a PDUFA target action date of August 27, 2026. source
- BLA for anito-cel in 4L+ R/R multiple myeloma accepted by FDA with PDUFA target action date of December 23, 2026. source
- FDA granted accelerated approval for Hepcludex for treatment of chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis, making it the first and only FDA-approved treatment for HDV in the U.S. source
- Received a positive EMA CHMP opinion for Trodelvy in combination with Keytruda for first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer with PD-L1 CPS≥10. source
- FDA approved Trodelvy for first-line treatment of adult patients with locally advanced or mTNBC as either a single agent for patients not candidates for PD-(L)1 inhibitor therapy or in combination with Keytruda or Keytruda Qlex for tumors expressing PD-L1 (CPS ≥10). source
- European Commission granted 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-(L)1 inhibitor therapy. source
- Received FDA full approval for Tecartus in adult patients with relapsed or refractory mantle cell lymphoma, and Tecartus label now includes data from Cohort 3 of ZUMA-2 study. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | FDA accepted a supplemental NDA for Yeztugo 300-mg tablet with a PDUFA target action date of February 2, 2027. |
| revenue | positive | probable | — | FDA accepted an NDA for bictegravir and lenacapavir for virologically suppressed people with HIV under priority review with a PDUFA target… |
| revenue | positive | probable | — | BLA for anito-cel in 4L+ R/R multiple myeloma accepted by FDA with PDUFA target action date of December 23, 2026. |
| revenue | positive | probable | — | FDA granted accelerated approval for Hepcludex for treatment of chronic hepatitis delta virus infection in adults without cirrhosis or… |
| revenue | positive | probable | — | Received a positive EMA CHMP opinion for Trodelvy in combination with Keytruda for first-line treatment of adult patients with… |