Will Capricor’s latest move give deramiocel new life?

Capricor hopes that refocusing the indication for deramiocel can shift FDA’s focus back to the primary endpoint of its Phase III HOPE-3 trial and at last bring its DMD cell therapy to patients. A BLA for deramiocel was one of several ensnared by controversy during the tenure of Marty Makary; it was then derailed by an FDA advisory committee vote that focused on the trial’s secondary endpoint.

Capricor Therapeutics Inc. (NASDAQ:CAPR) announced on a conference call late Thursday that it will amend its BLA for deramiocel to seek approval to improve limb function in Duchenne muscular dystrophy patients. The shift, from the prior indication in DMD cardiomyopathy, lifted Capricor shares 58% to $6.65 on Friday, bringing the company’s market cap close to $400 million — and where they were before the biotech received a complete response letter for deramiocel a little over a year ago. That’s still well below levels reached after Phase III data in December. ...