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
73%PolySignal estimate
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 indicated it does not plan to hold an advisory committee, which simplifies the review process and decreases the risk of late-stage delays [starting state].
- BBP-418 would be the first approved treatment for any form of LGMD, addressing a high unmet medical need [starting state].
What pushes it down
- The deadline of December 15, 2026, is only 18 days after the PDUFA date of November 27, 2026, meaning any standard three-month extension for a major amendment would push the decision past the deadline [starting state].
- The NDA relies on a surrogate biomarker (alpha-dystroglycan glycosylation) for accelerated approval, which carries inherent regulatory risks and potential for closer scrutiny [starting state].
What would move this number most
Whether the FDA will require additional analyses that trigger a major amendment and a three-month PDUFA extension, or issue a Complete Response Letter.
How this number is built
| Deadline | 2026-12-15 |
| Base rate | 73% |
| Best evidence | tier 4 · 4 article(s) used |
| Independent runs | 68 · 78 (spread 10 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-09-21 22:20 |
| Model | gemini-3.5-flash |
Sources consulted
Probability history
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).