Will the FDA approve encaleret in autosomal dominant hypocalcemia type 1 before 15 June 2027?
deadline 2027-06-15
confidence medium
tier 3 evidence
57%PolySignal estimate
Resolution criterion
Yes if the FDA approves the NDA by 15 June 2027 (Drugs@FDA or a BridgeBio 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 under standard review, PDUFA date 8 May 2027. The FDA has indicated it does not plan an advisory committee. This would be the first treatment designed specifically for ADH1. An ultra-rare disease, with an application resting on biochemical endpoints whose clinical translation remains to be established. (22 July 2026)
What pushes it up
- The FDA indicated it does not plan to convene an advisory committee, showing no immediate need for external panel deliberation [tier 1].
- Encaleret targets an ultra-rare condition (ADH1) with high unmet medical need and no approved targeted therapies, where the FDA frequently exercises regulatory flexibility [tier 1].
What pushes it down
- The PDUFA date is 8 May 2027, leaving only about five weeks before the 15 June 2027 deadline; any standard three-month review extension triggered by major data amendments would push the decision past the cutoff and trigger a negative resolution [tier 1].
- The application relies on biochemical endpoints whose clinical translation remains to be fully established, creating regulatory uncertainty on efficacy validation [tier 1].
- First-cycle reviews remain vulnerable to complete response letters driven by manufacturing, product quality, or clinical validation issues [tier 3].
What would move this number most
Whether the FDA accepts the biochemical surrogate endpoints as sufficient evidence of clinical benefit without requiring additional clinical outcome data or extending the review timeline.
How this number is built
| Deadline | 2027-06-15 |
| Base rate | 64% |
| Best evidence | tier 3 · 1 article(s) used |
| Independent runs | 56 · 58 (spread 2 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-09-27 09:10 |
| Model | gemini-flash-latest |
Sources consulted
Probability history
2026-09-27 09:10 57% 52 article(s) on file · gemini-flash-latest
- What pushes it up. The FDA indicated it does not plan to convene an advisory committee, showing no immediate need for external panel deliberation [tier 1].
- What pushes it up. Encaleret targets an ultra-rare condition (ADH1) with high unmet medical need and no approved targeted therapies, where the FDA frequently exercises regulatory flexibility [tier 1].
- What pushes it down. The PDUFA date is 8 May 2027, leaving only about five weeks before the 15 June 2027 deadline; any standard three-month review extension triggered by major data amendments would push the decision past the cutoff and trigger a negative resolution [tier 1].
- What pushes it down. The application relies on biochemical endpoints whose clinical translation remains to be fully established, creating regulatory uncertainty on efficacy validation [tier 1].
- What pushes it down. First-cycle reviews remain vulnerable to complete response letters driven by manufacturing, product quality, or clinical validation issues [tier 3].
- What would move this number most. Whether the FDA accepts the biochemical surrogate endpoints as sufficient evidence of clinical benefit without requiring additional clinical outcome data or extending the review timeline.
2026-09-26 09:17 72% 50 article(s) on file · openai/gpt-oss-120b (Groq)
- What pushes it up. NDA accepted and PDUFA date set for 8 May 2027, indicating FDA expects to complete review by then [tier 1]
- What pushes it up. FDA has indicated it does not plan an advisory committee, reducing procedural delay risk [tier 1]
- What pushes it down. Drug relies on biochemical endpoints in an ultra‑rare disease, which historically carries higher uncertainty for approval [tier 1]
- What pushes it down. Clinical data gaps are a common cause of complete response letters (27% of CRLs) in similar cases [tier 3]
- What pushes it down. No specific FDA communication confirming approval of encaleret has been issued yet, only general approvals of other products [tier 1]
- What would move this number most. Whether the FDA will issue a complete response letter or otherwise delay the decision beyond the PDUFA date
2026-09-21 22:24 72% 44 article(s) on file · openai/gpt-oss-120b (Groq)
Reasons not recorded for this revision (detailed history has only been kept since recently).
2026-09-20 09:01 81% 37 article(s) on file · gemini-3-flash-preview
Reasons not recorded for this revision (detailed history has only been kept since recently).