Bayer strengthens pharma portfolio with acquisition of EU rights to new cardiology drug acoramidis, for the treatment of patients suffering from ATTR CM.

Acoramidis is a highly potent and selective small molecule, orally administered transthyretin (TTR) stabilizer for the treatment of patients suffering from ATTR CM, a progressive fatal disease presenting as an infiltrative, restrictive cardiomyopathy resulting in heart failure.

In a placebo-controlled Phase III study in ATTR CM, acoramidis met all clinical endpoints by significantly reducing hospitalization burden, improved survival and preserved functional capacity and quality of life for patients in need. Marketing authorization application (MAA) with the European Medicines Agency (EMA) was filed in January 2024, after announcing that acoramidis successfully met the primary endpoint in the pivotal Phase III trial, confirming highly statistically significant efficacy and good tolerability in the trial population. New Drug Application (NDA) for acoramidis has also been submitted to FDA and accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024.

Under the terms of the agreement, BridgeBio and the affiliates will receive up to $310 million in upfront and near-term milestone payments and are eligible to receive additional undisclosed sales milestone payments and tiered-royalties beginning in the low-thirties percent.