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Shares of Capricor Therapeutics Inc. (NASDAQ: CAPR) are up Thursday after the company announced progress regarding one of its rare disease therapeutics. The biotech company’s stock jumped 18% immediately following the news.
What To Know: Capricor said it met with the U.S. Food and Drug Administration (FDA) to clarify the regulatory approval process for Deramiocel, the company’s investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD). The stock reached $7.32 on Thursday before pulling back a bit, according to Benzinga Pro.
The FDA sent a Complete Response Letter to the company in July outlining specific deficiencies in its current Biologics License Application for Deramiocel. Capricor met with the FDA after to outline how it could amend its application, including the submission of top-line data from a pivotal trial expected to be ready later this year.
The FDA said it requested an “additional study,” a requirement the two agreed that Deramiocel’s clinical trial could fulfill. Further, the FDA said it would “exercise further regulatory flexibility by reviewing data” from the trial. The Thursday announcement also reaffirmed that a majority of the company’s Biologics License Application did not have significant deficiencies or pre-licensing inspections.
“We are encouraged by the outcome of our discussions with the FDA, which provided clarity on our regulatory strategy and reinforced the opportunity to deliver HOPE-3 data as the basis for approval, should it meet regulatory requirements,” said Linda Marbán, Capricor’s CEO.
Capricor said in the release that it maintains a strong financial position to support the advancement of Deramiocel through regulatory review and toward potential launch. The company had approximately $122.8 million of cash, cash equivalents and marketable securities as of June 30.
CAPR Price Action: Capricor stock was up 5.49%, trading at $6.53 at the time of publication Thursday, according to Benzinga Pro.
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