Will the FDA approve tinlarebant in Stargardt disease type 1 before 30 April 2027?
deadline 2027-04-30
confidence medium
tier 4 evidence
71%PolySignal estimate
Resolution criterion
Yes if the FDA approves the NDA by 30 April 2027 (Drugs@FDA or a Belite Bio release). A complete response letter, a postponement of the PDUFA date, or the absence of a decision by that date count as no.
Verified starting state
NDA accepted with priority review, PDUFA date 12 February 2027. The DRAGON trial showed a 35.7% reduction in the growth rate of atrophic retinal lesions versus placebo. No treatment is approved to date for STGD1. The FDA has in the past declined to see clinical benefit in an anatomical endpoint without a functional correlate. (11 August 2026)
What pushes it up
- NDA accepted with priority review and a PDUFA decision date of 12 Feb 2027 set by the FDA (tier 1)
What pushes it down
- FDA has previously declined to consider anatomical endpoints without functional benefit, and the DRAGON trial only showed lesion‑growth reduction (tier 1)
What would move this number most
Whether the FDA will deem the anatomical endpoint sufficient to grant approval
How this number is built
| Deadline | 2027-04-30 |
| Base rate | 64% |
| Best evidence | tier 4 · 0 article(s) used |
| Independent runs | 70 · 72 (spread 2 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-09-21 22:25 |
| Model | openai/gpt-oss-120b (Groq) |
Probability history
2026-09-21 22:25 71% 13 article(s) on file · openai/gpt-oss-120b (Groq)
Reasons not recorded for this revision (detailed history has only been kept since recently).
2026-09-19 07:42 72% 11 article(s) on file · gemini-3.5-flash
Reasons not recorded for this revision (detailed history has only been kept since recently).