Capricor: Maintaining 'Hold' Rating On Randomized Phase 3 HOPE-3 Trial Win With Deramiocel

2025-12-07 08:21:00 ET

The last time I wrote about Capricor Therapeutics ( CAPR ) it was with respect to a Seeking Alpha article entitled " Capricor: Maintaining Hold Rating In Light of Deramiocel Complete Response Letter ". With respect to that article, I noted that the company had received a Complete Response Letter [CRL] from the FDA for its lead drug candidate, Deramiocel, for the treatment of cardiomyopathy in patients with Duchenne Muscular Dystrophy [DMD]. At that time, I believed that there was still a path forward based on two key items that were rapidly approaching. The first item of which was that the company was already gearing up to release results from the phase 3 HOPE-3 study using Deramiocel to treat these patients with DMD with cardiomyopathy around Q3/Q4 of 2025. The second item is that the company had requested a Type A meeting with the FDA to discuss a possible path forward. In essence, what exactly would be needed to gain U.S. marketing approval of this drug for the treatment of these specific DMD patients?...

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