Name in SEC filings: GILEAD SCIENCES, INC.
| Program | Event | Stage | Stated timing | Filing |
|---|---|---|---|---|
| anito-cel | target date (company stated) | PDUFA | December 23, 2026 | SEC filing · |
| lenacapavir oral 300-mg | PDUFA target date (company stated) | PDUFA | February 2, 2027 | SEC filing · |
Source: ORION, orionbiotechai.com/company/GILD, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/GILD
anito-cel · PDUFA target date (company stated) · December 23, 2026
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
relapsed or refractory multiple myeloma after at least three prior therapies
PDUFA target date (company stated)December 23, 2026
Stage: PDUFASEC filing · “PDUFA target action date”
Public float: $103,200,000,000 · as of · SEC filing
PDUFA target action date of December 23, 2026
SEC filing · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
HIV pre-exposure prophylaxis
PDUFA target date (company stated)February 2, 2027
Stage: PDUFASEC filing · “PDUFA”) target action date”
Public float: $103,200,000,000 · as of · SEC filing
Prescription Drug User Fee Act (“PDUFA”) target action date of February 2, 2027
SEC filing · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-02)
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| anito-celFDA decision | December 23, 2026“PDUFA target action date of December 23, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| lenacapavir oral 300-mgFDA decision | February 2, 2027“Prescription Drug User Fee Act (“PDUFA”) target action date of February 2, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| lenacapavir oral 300-mgFDA decision | February 2, 2027“Prescription Drug User Fee Act target action date of February 2, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| anito-celFDA decision | December 23, 2026“PDUFA target action date of December 23, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| anito-celFDA decision | December 23, 2026“PDUFA target action date of December 23, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| anito-celFDA decision | December 23, 2026“Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
Historical summaries and source dates are retained separately from the SEC timing quotes above. Earlier publications were collected retrospectively.
Historical catalog checked .
Source published · Original announcement
Retained timing label: Second half of 2024
Retained summary: Gilead expected a Phase 3 PURPOSE 1 update in the second half of 2024. The presentation described timing estimates, not a guaranteed efficacy outcome.
Source published · Original announcement
Retained summary: Gilead published results from a PURPOSE 1 interim analysis and reported a committee recommendation to stop the blinded phase. This interim announcement was earlier than the previously indicated update window; it was not final regulatory approval.
Original ClinicalTrials.gov record · Open the selected study
These are selected linked records and dated source metadata, not a live registry recheck or the company’s full pipeline. Company announcements and the selected registry study are separate evidence sets. No stage or event timing is borrowed between them.
Coverage and identity checksSuggest an SEC timing statement to add for GILD. You can include the original filing link in your note. The founder reads each request by hand.
Or email ORION.
See GILD in the calendar · Review labels and methodology