Gilead Sciences, Inc. GILD
Gilead Sciences, Inc. (Nasdaq: GILD) is an infectious disease drug developer. Its lead program, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), is in Phase 3 for HIV-1 infection. Its next catalyst on record is anito-cel: FDA action on BLA (PDUFA) (December 23, 2026).
Upcoming catalysts
- December 23, 2026anito-cel — FDA action on BLA (PDUFA)
target action date of December 23, 2026
- February 2, 2027lenacapavir weekly oral — FDA action on sNDA (PDUFA)
PDUFA") target action date of February 2, 2027
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Biktarvy | HIV | small molecule | Approved |
| Yeztugo (lenacapavir) | HIV PrEP | small molecule | Approved |
| Trodelvy | TNBC/UC | antibody | Approved |
| Livdelzi | PBC | small molecule | Approved |
| Yescarta/Tecartus | lymphoma/ALL | cell therapy | Approved |
| bictegravir/lenacapavir | HIV (virologically suppressed) | small molecule | Phase 3 |
| anito-cel | 4L+ R/R multiple myeloma | cell therapy | Phase 3 |
Recent results and decisions
- Feb 23, 2026accepted FDA accepted the anito-cel BLA for 4L+ R/R multiple myeloma with a PDUFA date of December 23, 2026 (disclosed in Gilead's Arcellx acquisition release).
has been accepted by the U.S. Food and Drug Administration with an anticipated Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 infectious disease companies
- GSK plc GSK
- Moderna, Inc. MRNA
- Vaxcyte, Inc. PCVX
- Vir Biotechnology, Inc. VIR
- Novavax Inc NVAX
- Sinovac Biotech Ltd SVA
- CorMedix Inc. CRMD
- Valneva SE VALN
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.