Capricor Therapeutics Inc (NASDAQ:CAPR) shares are trading higher Tuesday after the company announced intent to file a biologics license application (BLA) for the full approval of Deramiocel for the treatment of Duchenne muscular dystrophy cardiomyopathy.
What To Know: Capricor said it determined its intent to file a BLA following recent meetings with the U.S. Food and Drug Administration.
Based on those meetings, Capricor plans to commence the filling in October, seeking full approval of deramiocel for the treatment of DMD-cardiomyopathy with full submission expected by the end of the year.
The company noted that the filing will be based on existing cardiac data from the Phase 2 HOPE-2 and HOPE-2 Open Label Extension trials. Capricor said it plans to combine Cohorts A and B of the Phase 3 clinical trial to serve as a post-approval study.
"There are currently no approved therapies for DMD cardiomyopathy, which is the leading cause of death in those with Duchenne. Based on the strength of our cardiac data, combined with the FDA's commitment to advancing therapeutics for the treatment of rare diseases, we are seeking approval for the cardiomyopathy associated with DMD and will look to expand the label for skeletal muscle myopathy post-approval," said Linda Marbán, CEO of Capricor Therapeutics.
"Deramiocel has shown in multiple clinical trials attenuation of the cardiac implications of DMD. Based on the totality of evidence of the safety and efficacy data deramiocel has shown, we believe this is the best path forward to potential approval."
Capricor shares are now up more than 55% over the past week. The stock has been in the spotlight since the company signed a European expansion deal with Nippon Shinyaku. Several analysts have raised price targets on the stock since. Here's a look at all of the analyst updates over the past week.
- HC Wainwright & Co. analyst Joseph Pantginis reiterated Capricor Therapeutics with a Buy and maintained a price target of $40.
- Maxim Group analyst Jason McCarthy reiterates Capricor Therapeutics with a Buy and maintained a price target of $12.
- Oppenheimer analyst Leland Gershell maintained Capricor Therapeutics with an Outperform and raised the price target from $14 to $15.
- Cantor Fitzgerald analyst Kristen Kluska reiterated Capricor Therapeutics with an Overweight and maintained a price target of $8.
Don't Miss: EXCLUSIVE: Capricor Therapeutics Inks European Expansion, Commercialization Pact For Lead Asset With Japanese Pharma Firm
CAPR Price Action: Capricor shares were up 27.1% at $7.63 at the time of publication, according to Benzinga Pro.
Photo: 3844328 from Pixabay.
