GILD · 10-Q · 2026Q3 · Full report
Regulatory Approval Milestones
GILEAD SCIENCES, INC. · 2026-10-30 · Importance 34 · Surprise 42 · In source text
Gilead received FDA approval for Bixlenvo for adults with HIV who are virologically suppressed on a stable antiretroviral regimen, and FDA accelerated approval for Hepcludex for chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis. The FDA accepted Yeztugo’s supplemental NDA for a potential once-weekly oral HIV pre-exposure prophylaxis formulation, with a PDUFA target action date of February 2, 2027. In oncology, Trodelvy received European Commission marketing authorization and FDA approval for first-line treatment of specified patients with locally advanced or metastatic triple-negative breast cancer; Tecartus received FDA full approval for adults with relapsed or refractory mantle cell lymphoma. The filing provides no quantified financial impact for these regulatory actions.
Key facts
- The FDA accepted Gilead’s supplemental NDA for a potential once-weekly oral 300-mg Yeztugo formulation for HIV PrEP; the PDUFA target action date is February 2, 2027. source
- The FDA accepted Gilead’s BLA for anito-cel in 4L+ R/R multiple myeloma, with a PDUFA target action date of December 23, 2026. source
- Gilead received FDA accelerated approval for Hepcludex for chronic HDV in adults without cirrhosis or with compensated cirrhosis; it is the first and only FDA-approved HDV treatment in the U.S. source
- Gilead received European Commission marketing authorization for Trodelvy with Keytruda for first-line locally advanced or metastatic triple-negative breast cancer in adults whose tumors express PD-L1 (CPS≥10). source
- Gilead received FDA approval of Trodelvy for first-line locally advanced or metastatic TNBC, as monotherapy for patients not candidates for PD-(L)1 inhibitor therapy or with Keytruda or Keytruda Qlex for patients whose tumors express PD-L1 (CPS ≥10). source
- Gilead received EC marketing authorization for Trodelvy monotherapy for first-line unresectable locally advanced or metastatic TNBC in adults who are not candidates for PD-(L)1 inhibitor therapy. source
- Gilead received FDA full approval for Tecartus in adults with R/R mantle cell lymphoma, following accelerated approval in July 2020; the label now includes Cohort 3 ZUMA-2 data for patients R/R after one or more therapy lines and BTK-inhibitor-naïve. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | The FDA accepted Gilead’s supplemental NDA for a potential once-weekly oral 300-mg Yeztugo formulation for HIV PrEP; the PDUFA target… |
| revenue | positive | probable | — | The FDA accepted Gilead’s BLA for anito-cel in 4L+ R/R multiple myeloma, with a PDUFA target action date of December 23, 2026. |
| revenue | positive | probable | — | Gilead received FDA accelerated approval for Hepcludex for chronic HDV in adults without cirrhosis or with compensated cirrhosis; it is… |
| revenue | positive | probable | — | Gilead received European Commission marketing authorization for Trodelvy with Keytruda for first-line locally advanced or metastatic… |
| revenue | positive | probable | — | Gilead received FDA approval of Trodelvy for first-line locally advanced or metastatic TNBC, as monotherapy for patients not candidates… |
| revenue | positive | probable | — | Gilead received EC marketing authorization for Trodelvy monotherapy for first-line unresectable locally advanced or metastatic TNBC in… |
| revenue | positive | probable | — | Gilead received FDA full approval for Tecartus in adults with R/R mantle cell lymphoma, following accelerated approval in July 2020; the… |