FDA approves BBP-418 for limb-girdle muscular dystrophy type 2I/R9 on or before the disclosed PDUFA goal date of 2026-11-27

The proposition

What was claimed

The FDA takes an approval action on BridgeBio Pharma's New Drug Application for oral BBP-418 for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), with an approval action date on or before 2026-11-27, the PDUFA target action date disclosed in BridgeBio's Form 8-K filed 2026-08-31.

Authority

US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)

Target rungA step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung

Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc.

Forecast classThe group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates

FDA action by goal date

Scope

Limb-girdle muscular dystrophy type 2I/R9

The clock

Dates that constrain the record

resolution window

Today

Evidence cutoff2026-09-26 Registered2026-09-26 Window opens2026-09-27 Deadline2026-11-27

Evidence cutoff

2026-09-26

Registered

2026-09-26

Window opens

2026-09-27

Deadline

2026-11-27

Evidence cutoff

2026-09-26
Nothing after this date informed the estimate.

Registered

2026-09-26
Frozen and hashed.

Resolution window

2026-09-27 → 2026-11-27
When the adjudicator can read the outcome.

Event by

2026-11-27
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar

ledger 56a534eeec5d40e039a81e7783a01a2d1661afbbb6bb11f9b30d64fd36dbdf25 Copy · operator record jc-1790461082259-3f5083f6

Resolution

The rule that settles the forecast

The application number was not public at the cutoff, and no archived source gives an FDA established name for BBP-418; BridgeBio's own filings identify its compound as ribitol (SRC-004). The adjudicator therefore identifies the application by its indication plus its ingredient or its applicant, never by a name the adjudicator infers: the qualifying application is an NDA whose Drugs@FDA approval letter or label names limb-girdle muscular dystrophy type 2I/R9 (also written LGMD2I, LGMD R9 or FKRP-related limb-girdle muscular dystrophy) in its indication, and whose active ingredient is ribitol or whose applicant is BridgeBio Pharma or a BridgeBio subsidiary, under any proprietary name. Resolves YES if such an application appears in the openFDA Drugs@FDA endpoint, located by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ribitol%22, with an ORIG submission whose submission_status is AP and whose submission_status_date is on or before 2026-11-27. An approval for a narrower LGMD2I/R9 population than the applicant sought (by age or genotype, for example) still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2026-11-27: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-27 resolves NO as occurred_after_deadline. 2026-11-27 is a Friday. Read no earlier than 2026-12-11. If openFDA has not refreshed by then, or the query returns nothing, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name ribitol or by the applicant) governs, under the same identification test. Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands.

Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ribitol%22, https://www.accessdata.fda.gov/scripts/cder/daf/

Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far.

What this record will show once it resolves

Frozen covariatesThe facts about the evidence and the authority's process that were frozen with the forecast at its cutoff

The state of the record at the cutoff

Recorded as they stood on 2026-09-26, including the 2 fields whose values were unknown then. Those are left unknown rather than filled in.

review pathway

Priority Review (SRC-001, SRC-002); Orphan Drug, Fast Track and Rare Pediatric Disease designations (SRC-002)

submission type

original NDA; oral small molecule, identified by BridgeBio as ribitol (SRC-004); application number not public

evidence class

placebo-controlled phase 3 trial, FORTIFY, at a pre-specified 12-month interim analysis (SRC-002, SRC-003)

pivotal n

unknown — not stated in the archived sources

endpoint type

unknown in the archive — FORTIFY met all pre-specified primary and secondary endpoints at interim, which the archived sources do not name; the drug is meant to restore alpha-dystroglycan glycosylation (SRC-002)

approved competitors in class

none — BridgeBio states BBP-418 would be the first approved therapy for LGMD2I/R9 and for any form of LGMD (SRC-002)

months since last guideline revision

not applicable — no guideline is the subject of this proposition

panel cycle position

not applicable — the act is an FDA approval action

sponsor request status

NDA accepted for filing with Priority Review on 2026-05-27 (SRC-002)

odac referral

none planned — FDA said at filing it was not currently planning an advisory committee meeting; restated 2026-08-10 (SRC-002, SRC-003)

sponsor state change

none recorded in the archived sources since NDA acceptance