Acoramidis

Bayer AG received EU regulatory support for its cardiology drug acoramidis, aimed at treating transthyretin amyloidosis in adults with cardiomyopathy, as it seeks to mitigate the impact of upcoming patent expirations.

CHMP recommends EU approval for acoramidis, a treatment for ATTR-CM, based on Phase 3 study results showing a 42% reduction in mortality and hospitalization. Approved in the U.S. as Attruby™, final EU decision expected early 2025, with Bayer planning a European launch.

BridgeBio Pharma announced CHMP recommended EU approval of acoramidis for ATTR-CM, following Phase 3 ATTRibute-CM study results showing a 42% reduction in mortality and cardiovascular hospitalization events, and a 50% reduction in cumulative hospitalization events at Month 30. The drug was FDA-approved as Attruby™ in 2024, the first near-complete stabilization treatment for ATTR-CM in the US. Bayer plans to launch acoramidis in Europe in H1 2025.

CHMP recommended EU approval of acoramidis based on ATTRibute-CM Phase 3 study results, showing rapid benefits in ATTR-CM patients. Acoramidis, a near-complete TTR stabilizer, was FDA-approved as Attruby™ in 2024 for reducing cardiovascular death and hospitalization in ATTR-CM. European Commission approval expected soon, with Bayer planning a 2025 European launch.

The CHMP recommended EU approval for acoramidis, a TTR stabilizer, based on Phase 3 ATTRibute-CM study results showing significant cardiovascular benefits. FDA-approved as Attruby™ in the U.S., it's the first ATTR-CM treatment achieving near-complete TTR stabilization. Final EU decision expected soon, with Bayer planning a 2025 launch in Europe.

The CHMP recommended EU approval for acoramidis, a TTR stabilizer, following positive Phase 3 ATTRibute-CM study results. Acoramidis, approved in the U.S. as Attruby™, reduces cardiovascular death and hospitalization in ATTR-CM patients. Final EU approval is expected soon, with a European launch planned for 2025.

EU decision on marketing approval for 13 new products, including BridgeBio’s acoramidis, is imminent.

BofA increased BridgeBio's (BBIO) price target to $45, maintaining a Buy rating, following FDA approval of acoramidis (Attruby) for ATTR-CM, seen as a significant milestone for the company's commercial evolution.