BridgeBio Submits NDA to FDA for BBP-418 for Individuals Living with LGMD2I/R9
BridgeBio Pharma, Inc. (BBIO)
Last bridgebio pharma, inc. earnings: 3/2 08:29 am
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Source: GlobeNewswire
- Comprehensive submission includes interim Phase 3 FORTIFY data demonstrating BBP-418’s rapid, consistent treatment effect and favorable safety profile, with statistically significant and clinically meaningful improvements in ambulation and pulmonary function - Based on ongoing discussions with the FDA, BridgeBio anticipates approval with a U.S. launch anticipated in late 2026/early 2027 - If approved, BBP-418 has the potential to become the first and only therapy for individuals living with LGMD2I/R9 and may represent the first approved treatment for any form of LGMD PALO ALTO, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced the submission of its New Drug Application (NDA) to the FDA for oral BBP-418 for the treatment of individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). “This NDA submis
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News
- Mizuho Lifts PT on BridgeBio Pharma (BBIO) to $106 From $91 – Here's Why [Yahoo! Finance]Yahoo! Finance
- Acoramidis Significantly Reduces the Risk of All-Cause and Cardiovascular Mortality in Patients with ATTR-CM through Month 54GlobeNewswire
- BridgeBio Submits NDA to FDA for BBP-418 for Individuals Living with LGMD2I/R9 [Yahoo! Finance]Yahoo! Finance
- Will New Long-Term ATTRibute-CM Data on Acoramidis Shift BridgeBio Pharma's (BBIO) Narrative? [Yahoo! Finance]Yahoo! Finance
- BridgeBio to Present Long-Term Efficacy and Safety Data from the ATTRibute-CM OLE Trial at the ACC Annual Scientific SessionsGlobeNewswire
BBIO
Earnings
- 2/24/26 - Miss
BBIO
Sec Filings
- 4/2/26 - Form SCHEDULE
- 3/30/26 - Form 8-K
- 3/26/26 - Form SCHEDULE
- BBIO's page on the SEC website