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BridgeBio Announces FDA Acceptance and Priority Review of NDA for BBP-418 for LGMD2I/R9
BridgeBio Announces FDA Acceptance and Priority Review of NDA for BBP-418 for
About this update from Bridgebio Pharma, Inc.
[{"type":"text","content":"- Accepted for Priority Review with PDUFA target action date of November 27, 2026, and poised to launch upon approval; being granted Priority Review by the FDA reiterates the serious unmet need for treatment options for the LGMD2I/R9 community- If approved, BBP-418 would be the first and only therapy for individuals living with LGMD2I/R9 and would represent the first approved treatment for any form of LGMD- BBP-418 demonstrated strong, consistent efficacy across all prespecified subgroups with treated individuals improving on every key endpoint while placebo recipients declined, reflecting both the natural progression of this devastating disease and the meaningful potential impact for those on treatment PALO ALTO, Calif., May 27, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the FDA has accepted for filing its New Drug Application (NDA) with Priority Review for oral BBP-418 for the treatment of individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026, and BridgeBio is poised to launch BBP-418 upon approval. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application. “LGMD2I/R9 is a relentless and life-shortening disease. Patients progressively lose the ability to walk, face serious cardiovascular complications, and ultimately die from respiratory failure,” said Christine Siu, Chief Executive Officer of BridgeBio Neuromuscular. “With today's acceptance of our NDA, we are one step closer to the potential FDA approval of a treatment that could potentially change the progression of this disease. The compelling data from FORTIFY give us confidence that BBP-418 can make a meaningful difference in how this disease progresses, and we will work with urgency to bring it to the patients and families who have been waiting.” In the Phase 3 FORTIFY trial, BBP-418 met all primary and secondary endpoints at the pre-specified 12-month interim analysis, showing treated individuals improving while placebo recipients declined across every key measure. These results were presen...