BridgeBio Announces FDA Acceptance Of NDA For Acoramidis

(RTTNews) - Monday, BridgeBio Pharma, Inc. (BBIO) announced that the FDA has accepted the Company's New Drug Application or NDA for acoramidis, an investigational drug for treating ATTR-CM.

The company stated that the application was supported by positive results from ATTRibute-CM, the Company's Phase 3 study assessing the effectiveness and safety. Acoramidis is an investigational, next-generation, orally administered, highly potent, small-molecule stabilizer of transthyretin.

The FDA has established a November 29, 2024, action date under the PDUFA.

Additionally, the company said that its Marketing Authorization Application with the European Medicines Agency has been accepted, and preparations are underway for further global regulatory submissions.