Will the FDA approve BBP-418 in limb-girdle muscular dystrophy type 2I/R9 before 15 December 2026?
deadline 2026-12-15
confidence medium
tier 4 evidence
81%Asturna estimate
⚠ Evidence cap applied: the model proposed 85%, brought back to 81% for lack of sources solid enough to justify the departure from the base rate.
Resolution criterion
Yes if the FDA approves the NDA by 15 December 2026 (Drugs@FDA or a BridgeBio release). A complete response letter, a postponed PDUFA date, or no decision by that date all count as no.
Verified starting state
NDA accepted with priority review, PDUFA date 27 November 2026. The FDA has indicated it does not plan an advisory committee. This would be the first approved treatment for any form of LGMD, on a surrogate biomarker (alpha-dystroglycan glycosylation). (27 May 2026)
What pushes it up
- The FDA has granted priority review and set a PDUFA date of November 27, 2026, which is before the deadline [1]
- The FDA has indicated it does not plan to hold an advisory committee meeting, which typically suggests a straightforward review process [1]
- Recent Phase 3 interim data (October 2026) showed positive results in clinical endpoints including ambulation, pulmonary function, and cardiac data [0, 3]
- BBP-418 addresses a significant unmet need as the first potential treatment for any form of LGMD [1]
What pushes it down
- The approval relies on a surrogate biomarker (alpha-dystroglycan glycosylation), which carries inherent regulatory risk compared to hard clinical endpoints [1]
- Any standard three-month PDUFA extension would push the decision date past the December 15, 2026 deadline
What would move this number most
The primary uncertainty is whether the FDA finds the surrogate biomarker data sufficiently predictive of clinical benefit to support approval.
How this number is built
| Deadline | 2026-12-15 |
| Base rate | 73% |
| Best evidence | tier 4 · 4 article(s) used |
| Independent runs | 81 · 81 (spread 0 pts) |
| Confidence | medium |
| Evidence cap | applied: 85% brought back to 81% |
| Last revised | 2026-10-10 09:10 |
| Model | gemini-3-flash-preview |
Sources consulted
Probability history
2026-10-10 09:10 81% 12 article(s) on file · gemini-3-flash-preview
- What pushes it up. The FDA has granted priority review and set a PDUFA date of November 27, 2026, which is before the deadline [1]
- What pushes it up. The FDA has indicated it does not plan to hold an advisory committee meeting, which typically suggests a straightforward review process [1]
- What pushes it up. Recent Phase 3 interim data (October 2026) showed positive results in clinical endpoints including ambulation, pulmonary function, and cardiac data [0, 3]
- What pushes it up. BBP-418 addresses a significant unmet need as the first potential treatment for any form of LGMD [1]
- What pushes it down. The approval relies on a surrogate biomarker (alpha-dystroglycan glycosylation), which carries inherent regulatory risk compared to hard clinical endpoints [1]
- What pushes it down. Any standard three-month PDUFA extension would push the decision date past the December 15, 2026 deadline
- What would move this number most. The primary uncertainty is whether the FDA finds the surrogate biomarker data sufficiently predictive of clinical benefit to support approval.
2026-10-06 09:17 81% 12 article(s) on file · openai/gpt-oss-20b (Groq)
- What pushes it up. NDA accepted with priority review and a PDUFA date of 27 Nov 2026 indicates a high likelihood of approval before 15 Dec 2026 [tier 1]
- What pushes it down. No evidence of safety or efficacy concerns that could delay the review; the only potential downside is the possibility of unforeseen issues arising during the review process, but no such signals are present
- What would move this number most. Unforeseen safety or efficacy findings that could trigger a review delay or rejection
2026-09-21 22:20 73% 5 article(s) on file · gemini-3.5-flash
Reasons not recorded for this revision (detailed history has only been kept since recently).
2026-09-19 07:34 90% 5 article(s) on file · gemini-3-flash-preview
Reasons not recorded for this revision (detailed history has only been kept since recently).