Sponsor reports acceptance for a once-weekly oral PrEP formulation, with a February 2, 2027 FDA target.
- Published
- Jun 15, 2026
- Retrieved
- 2026-10-30 02:09:48 UTC
Rx-GILD-2702 · February 2, 2027 sponsor target
Will the FDA approve Oral lenacapavir for HIV pre-exposure prophylaxis?
Sponsor reports acceptance for a once-weekly oral PrEP formulation, with a February 2, 2027 FDA target.
Open outcome workspaceA PDUFA goal date is not an approval determination or a trading cutoff. Application scope, delays and invalid-result terms require reviewed rules.
3 publications0 exact-program3 related3 context / correction notes
Publication and retrieval dates are shown separately. Market rules determine which evidence can resolve an outcome.
Sponsor reports acceptance for a once-weekly oral PrEP formulation, with a February 2, 2027 FDA target.
Sponsor presentation links lenacapavir to published small-molecule capsid-inhibitor research; it does not establish once-weekly approval.
This research candidate has no onchain question, committed rule hash or funded pool.
These terms require review and cannot resolve a market.
RESEARCH DRAFT / NOT FINAL RULES / NOT COMMITTED Program: Oral lenacapavir Sponsor: Gilead Sciences Indication under review: HIV pre-exposure prophylaxis Event: FDA marketing-approval decision Sponsor target: 2027-02-02 (date only, not a trading cutoff) YES: FDA approval of the exact application, formulation and eligible indication, established under a reviewed evidence hierarchy. Exact application/label scope requires review. NO: The approved market terms must specify treatment of a Complete Response Letter, withdrawal, extension and no decision by cutoff. No automatic NO outcome is inferred from the sponsor target date. INVALID: The approved terms must specify erroneous dates, ambiguous identity, unsupported evidence and withdrawal handling. No policy has been committed for this candidate. Cutoff and timezone: UNSET / OWNER APPROVAL REQUIRED. Evidence: FDA approval letter or other authoritative FDA record; sponsor disclosures require the corroboration specified in final rules. Oracle: assertion, dispute bond, liveness and final settlement require separately reviewed deployment settings. This draft cannot resolve a market or pay a claim. Publish reviewed canonical bytes and their keccak256 commitment before listing.
No question ID, approved deadline or UMA assertion exists for this research candidate. Sandbox claims have no redemption rights.