Bridgebio Pharma to submit NDA to FDA in 3Q
BridgeBio Pharma (Nasdaq: BBIO) has announced plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2026 for one of its investigational therapies. This follows recent regulatory milestones for two of its key drug candidates, acoramidis and BBP-418, both of which have demonstrated significant clinical potential in treating rare genetic diseases.
In February 2024, the FDA accepted the NDA for acoramidis, an oral therapy for transthyretin amyloid cardiomyopathy (ATTR-CM), with PDUFA action date November 29. The application was supported by positive results from the Phase 3 ATTRibute-CM trial, which showed an 81% absolute survival rate and a marked reduction in cardiovascular-related hospitalizations. The European Medicines Agency (EMA) also accepted the Marketing Authorization Application for acoramidis, with additional global regulatory submissions planned.
In May 2026, the FDA accepted the NDA for BBP-418, an oral therapy for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), with PDUFA target action date of November 27, 2026. The FDA granted Priority Review for BBP-418, underscoring the unmet medical need for this rare and severe condition. The Phase 3 FORTIFY trial demonstrated strong and consistent efficacy across all prespecified subgroups, with treated individuals showing improvement on key endpoints while placebo recipients declined.
BridgeBio’s upcoming NDA submission in 3Q 2026 reflects the company’s continued progress in its pipeline of therapies for genetically driven diseases. The company has adopted a decentralized, hub-and-spoke model to accelerate drug development and regulatory approval, with addressing conditions where treatment options remain limited.
As BridgeBio advances its regulatory strategy, investors will be closely monitoring the FDA’s review timelines and the potential for commercialization of these therapies. The company’s recent successes with acoramidis and BBP-418 highlight its commitment to developing transformative medicines for underserved patient populations.
