Capricor Therapeutics (CAPR) Q2 FY26 earnings call

Capricor Therapeutics is navigating a complex regulatory path for its lead asset, Deramiocel, following a disappointing FDA Advisory Committee vote on its initial cardiomyopathy indication. The company plans to submit an amendment to its BLA, focusing on an upper limb skeletal muscle indication, which the FDA has indicated it will review, extending the PDUFA date. While commercial readiness continues at a slower pace and other pipeline programs are on hold, the company maintains a strong cash position and is pursuing arbitration in its dispute with NS Pharma.