Capricor Therapeutics Inc (NASDAQ:CAPR)
Shares of Capricor Therapeutics Inc (NASDAQ:CAPR) rallied by 98.57% in Monday’s trading session, after the company received a Rare Pediatric Disease Designation (PDD) from the U.S. Food and Drug Administration (FDA). The PDD is in relation to the company’s candidate treatment for Duchene muscular dystrophy, CAP-1002.
The stock of Capricor Therapeutics Inc (NASDAQ:CAPR) gapped higher on Monday following the positive FDA news. The stock has underperformed the overall industry after it traded at highs of $3.43 a share a year ago.
Capricor Therapeutics Inc (NASDAQ:CAPR) is a clinical stage biotechnology company focused on the development of first class biological therapies. The company discovers, develops, and commercializes regenerative medicines for the treatment of various diseases with a focus on cardiovascular diseases.
CAP-1002 is the company’s lead product currently in clinical development. The company is also working on CAP-2003, a cell-free exosomes candidate for the treatment of various disorders.
The Rare Pediatric Disease Designation as well as Orphan Drug Designation (ODD) means CAP-1002 stands to receive Rare Pediatric Disease Priority Review that should accelerate its review process. The voucher can be used to obtain a priority review for New Drug Application or Biologic Licenses Application. The voucher can be sold or transferred unlimited number of times.
CAP-1002 FDA’s designation adds to a previous Orphan Drug Designation for the treatment of Duchene Muscular Dystrophy. The designation, according to Chief Executive Officer Linda Marban, underscores the urgent need for the drug in the treatment of the rare disease.
“We believe CAP-1002 has the potential to provide meaningful clinical benefit to patients. We look forward to commencing our next clinical trial in DMD, for which design will be relevant to the overall registration plan for this candidate,” said Madam Marban.
Capricor Therapeutics Inc (NASDAQ:CAPR) announced positive results in Phase I/II Hope Clinical trial of CAP-1002 in patients struggling with DM. The company is currently in discussions with the FDA to discuss potential product registration strategies.
There are also plans to commence randomized double-blind placebo-controlled clinical trial in boys and young men struggling with Duchene. The trials could commence in the second half of the year subject to regulatory approval.
Separately, Capricor Therapeutics Inc (NASDAQ:CAPR) reported a net loss of $3.7 million for the first three months of the year. Revenues in the quarter totaled $880,000.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.