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# BridgeBio Filing NDA for Acoramidis
- URL: https://www.fdaweb.com/bridgebio-filing-nda-for-acoramidis/
- Published: 2023-11-13T12:00:00.000Z
- Updated: 2026-09-14T14:16:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155775

BridgeBio Pharma says it will submit by 12/31 an NDA for acoramidis after releasing Phase 3 data from its ATTRibute-CM study of acoramidis in transthyretin amyloid cardiomyopathy (ATTR-CM). The study of the next-generation, small molecule stabilizer of transthyretin (TTR) demonstrated that it “improved clinical outcomes for ATTR-CM patients, even in the contemporary care setting,” the company says. “The early and sustained benefit on survival and cardiovascular-related hospitalization is remarkable and builds evidence towards the therapeutic hypothesis that near-complete TTR stabilization may improve clinical outcomes for ATTR-CM patients.” BridgeBio also says acoramidis was well-tolerated, and no safety signals of potential clinical concern were identified in the study.