Deramiocel is an investigational cell therapy aimed at treating patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy.
Shares of Capricor Therapeutics ($CAPR) were up 8.41% up on Thursday after the rare diseases-focused biotech said it completed the submission of its Biologics License Application (BLA) for for Deramiocel to the U.S. Food and Drug Administration, lifting retail sentiment.
Deramiocel is an investigational cell therapy aimed at treating patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy.
“The submission of the BLA marks a pivotal step for Capricor and those impacted by DMD. This BLA is the culmination of a body of work that has been focused on bringing this potentially transformational therapy to those patients in need,” Linda Marbán, CEO of Capricor said in a statement. “We believe that the strength of this application is that deramiocel has shown in multiple clinical trials attenuation of the cardiac implications of DMD.”
In conjunction with this submission, Capricor said it will receive a milestone payment of $10 million from its distribution partner, Nippon Shinyaku Co. under the terms of its U.S. commercialization and distribution agreement, the company said.
Following the development, retail mood on Stocktwits jumped to ‘extremely bullish' from 'barish' a day ago. Message volumes also climbed into the 'high' zone.
Duchenne muscular dystrophy is a devastating genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles with mortality at a median age of approximately 30 years, according to Capricor.
Last month Capricor said it would raise about $75M in gross proceeds via a public offering.
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