# BBP-418 (ribitol) PDUFA Event: Limb-girdle muscular dystrophy type 2I/R9

Canonical URL: https://biopharmsignal.com/pdufa-calendar/BBIO/bbp-418-lgmd2i-r9

Ticker: BBIO

Company: BridgeBio

Event date: 2026-11-27

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned a November 27, 2026 PDUFA target action date to the BBP-418 NDA.

## Event Timeline

### November 27, 2026 — FDA decision expected

FDA assigned a November 27, 2026 PDUFA target action date to the BBP-418 NDA.

[BridgeBio — NDA acceptance and PDUFA date](https://investor.bridgebio.com/news/news-details/2026/BridgeBio-Announces-FDA-Acceptance-and-Priority-Review-of-NDA-for-BBP-418-for-LGMD2IR9/default.aspx)

### May 27, 2026 — FDA accepted the NDA with Priority Review

FDA accepted the traditional-approval application and said it did not then plan an advisory committee meeting.

[BridgeBio — NDA acceptance and Priority Review](https://investor.bridgebio.com/news/news-details/2026/BridgeBio-Announces-FDA-Acceptance-and-Priority-Review-of-NDA-for-BBP-418-for-LGMD2IR9/default.aspx)

### March 11, 2026 — Additional FORTIFY results were presented

The Phase 3 interim analysis showed consistent efficacy across prespecified subgroups and improvement across key functional endpoints.

[BridgeBio — Detailed FORTIFY interim results](https://investor.bridgebio.com/news/news-details/2026/BBP-418-Demonstrates-Consistent-Efficacy-and-Favorable-Safety-Profile-in-Phase-3-FORTIFY-Interim-Analysis-in-LGMD2IR9/)

### October 27, 2025 — FORTIFY met all interim-analysis endpoints

The Phase 3 study met its primary and secondary interim endpoints, including measures of alpha-dystroglycan glycosylation, muscle damage, ambulatory function and pulmonary function.

[BridgeBio — Positive Phase 3 FORTIFY results](https://investor.bridgebio.com/news/news-details/2025/BridgeBio-Reports-Positive-Phase-3-Results-for-Small-Molecule-BBP-418-in-LGMD2IR9-FORTIFY-Study/default.aspx)

### May 31, 2023 — Phase 3 FORTIFY study started

The pivotal FORTIFY study began evaluating BBP-418 in patients with limb-girdle muscular dystrophy type 2I/R9.

[ClinicalTrials.gov — FORTIFY study record (NCT05775848)](https://clinicaltrials.gov/study/NCT05775848)

## Regulatory Designations

- Priority Review FDA: [BridgeBio — NDA acceptance and Priority Review](https://investor.bridgebio.com/news/news-details/2026/BridgeBio-Announces-FDA-Acceptance-and-Priority-Review-of-NDA-for-BBP-418-for-LGMD2IR9/default.aspx)

- Fast Track FDA: [BridgeBio — NDA acceptance and regulatory designations](https://investor.bridgebio.com/news/news-details/2026/BridgeBio-Announces-FDA-Acceptance-and-Priority-Review-of-NDA-for-BBP-418-for-LGMD2IR9/default.aspx)

- Orphan Drug FDA: [BridgeBio — NDA acceptance and regulatory designations](https://investor.bridgebio.com/news/news-details/2026/BridgeBio-Announces-FDA-Acceptance-and-Priority-Review-of-NDA-for-BBP-418-for-LGMD2IR9/default.aspx)

- Rare Pediatric Disease FDA: [BridgeBio — NDA acceptance and regulatory designations](https://investor.bridgebio.com/news/news-details/2026/BridgeBio-Announces-FDA-Acceptance-and-Priority-Review-of-NDA-for-BBP-418-for-LGMD2IR9/default.aspx)

- Orphan Drug EMA: [BridgeBio — NDA acceptance and regulatory designations](https://investor.bridgebio.com/news/news-details/2026/BridgeBio-Announces-FDA-Acceptance-and-Priority-Review-of-NDA-for-BBP-418-for-LGMD2IR9/default.aspx)

## Related Pages

- BBIO PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/BBIO.md

- BBIO company profile: https://biopharmsignal.com/company/BBIO.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

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