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Tinlarebant / FDA decision

Research only

Rx-BLTE-2702 · February 12, 2027 sponsor target

Event question

Will the FDA approve Tinlarebant for Stargardt disease type 1?

Sponsor reports NDA acceptance for tinlarebant in Stargardt disease and a February 12, 2027 FDA target.

Open outcome workspace
Sponsor target
February 12, 2027
Source published
Aug 11, 2026
Research snapshot
Oct 28, 2026
Trading status
Research / unlisted

A PDUFA goal date is not an approval determination or a trading cutoff. Application scope, delays and invalid-result terms require reviewed rules.

Published evidence

2 publications0 exact-program2 related2 context / correction notes

Review publications

Sources

Publication and retrieval dates are shown separately. Market rules determine which evidence can resolve an outcome.

sponsor-releasebelitebio.gcs-web.com
Sponsor reports NDA acceptance for tinlarebant in Stargardt disease and a February 12, 2027 FDA target.
Published
Aug 11, 2026
Retrieved
2026-10-30 02:09:48 UTC
sponsor-programbelitebio.com
Sponsor describes tinlarebant as an oral small-molecule RBP4 antagonist.
Published
Not supplied
Retrieved
2026-10-30 02:09:48 UTC
clinical-trial-registryclinicaltrials.gov
Registry identifies the associated compound, condition and sponsor; trial completion is separate from FDA action.
Published
Not supplied
Retrieved
2026-10-30 02:09:48 UTC

Resolution not committed

This research candidate has no onchain question, committed rule hash or funded pool.

Draft outcome criteria

These terms require review and cannot resolve a market.

YES
Approval of the exact application, formulation and eligible indication, established under the reviewed evidence hierarchy. Application and label scope still require review.
NO
Final terms must specify a Complete Response Letter, withdrawal, extension and no decision by cutoff. The sponsor’s target date alone cannot establish NO.
INVALID
Final terms must specify ambiguous identity, erroneous dates and unsupported evidence. No policy has been committed for this candidate.
Read the full research draft
RESEARCH DRAFT / NOT FINAL RULES / NOT COMMITTED

Program: Tinlarebant
Sponsor: Belite Bio
Indication under review: Stargardt disease type 1
Event: FDA marketing-approval decision
Sponsor target: 2027-02-12 (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.