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.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.