BEYONTTRA™ (acoramidis), the First Near Complete TTR Stabilizer (≥90%), Approved by the European Commission to Treat ATTR-CM

Core Points - BridgeBio Pharma, Inc. has received marketing authorization from the European Commission for acoramidis, branded as BEYONTTRA™, for treating wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) [1][4] - Acoramidis is a selective small molecule that stabilizes transthyretin (TTR) by ≥90% and is administered orally [1][8] - Bayer will handle all commercial activities for acoramidis in the EU, with a launch planned for the first half of 2025 [4][5] Clinical Study Results - The approval is based on the pivotal ATTRibute-CM Phase 3 study, which involved 632 participants and demonstrated significant benefits in cardiovascular outcomes [3][7] - The study showed a 42% reduction in composite all-cause mortality (ACM) and recurrent cardiovascular-related hospitalizations (CVH) events at month 30 compared to placebo [7] - Acoramidis is the first and only approved treatment for ATTR-CM in the U.S. and EU with a label specifying near-complete stabilization of TTR [7] Financial Aspects - BridgeBio will receive a $75 million milestone payment from Bayer upon European Commission approval and will earn tiered royalties starting in the low-thirties percent on sales of acoramidis in the EU [5][7] - Since its U.S. approval in November 2024, BridgeBio has reported strong commercial momentum with 430 patient prescriptions written by 248 physicians [4][5] Future Prospects - Acoramidis is currently under review for approval by the Japanese Pharmaceuticals and Medical Devices Agency and the Brazilian Health Regulatory Agency [6]