Will the FDA approve tinlarebant in Stargardt disease type 1 before 30 April 2027?
deadline 2027-04-30
confidence medium
tier 4 evidence
58%Asturna estimate
⚠ Evidence cap applied: the model proposed 55%, brought back to 58% for lack of sources solid enough to justify the departure from the base rate.
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
- The FDA accepted the NDA with priority review, indicating the drug addresses a significant unmet need [1]
- The Phase 3 DRAGON trial met its primary endpoint, showing a 35.7% reduction in atrophic retinal lesion growth [1]
- There are currently no approved treatments for Stargardt disease type 1 (STGD1) [1]
What pushes it down
- The FDA has historically been skeptical of anatomical endpoints, such as lesion growth, without a corresponding functional correlate like visual acuity [1]
- A Complete Response Letter (CRL) or a request for additional functional data would prevent approval before the April 2027 deadline [1]
What would move this number most
The primary uncertainty is whether the FDA will accept the reduction in atrophic retinal lesion growth as a sufficient surrogate for clinical benefit in the absence of functional data.
How this number is built
| Deadline | 2027-04-30 |
| Base rate | 64% |
| Best evidence | tier 4 · 2 article(s) used |
| Independent runs | 56 · 60 (spread 4 pts) |
| Confidence | medium |
| Evidence cap | applied: 55% brought back to 58% |
| Last revised | 2026-10-07 09:09 |
| Model | gemini-3-flash-preview |
Sources consulted
Probability history
2026-10-07 09:09 58% 18 article(s) on file · gemini-3-flash-preview
- What pushes it up. The FDA accepted the NDA with priority review, indicating the drug addresses a significant unmet need [1]
- What pushes it up. The Phase 3 DRAGON trial met its primary endpoint, showing a 35.7% reduction in atrophic retinal lesion growth [1]
- What pushes it up. There are currently no approved treatments for Stargardt disease type 1 (STGD1) [1]
- What pushes it down. The FDA has historically been skeptical of anatomical endpoints, such as lesion growth, without a corresponding functional correlate like visual acuity [1]
- What pushes it down. A Complete Response Letter (CRL) or a request for additional functional data would prevent approval before the April 2027 deadline [1]
- What would move this number most. The primary uncertainty is whether the FDA will accept the reduction in atrophic retinal lesion growth as a sufficient surrogate for clinical benefit in the absence of functional data.
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).