Capricor Therapeutics (NASDAQ: CAPR) shares are up 30% after the company said the U.S. FDA has indicated it is willing to accept the company’s proposal to use the Performance of the Upper Limb as the basis for the primary efficacy endpoint for clinical studies of CAP-1002 for the treatment of muscular dystrophy. Official minutes from the company’s recent meeting with the regulatory agency also show support for submission of an Investigational New Drug (IND) application to clinically evaluate repeat intravenous administration of CAP-1002. “The FDA’s response to our proposed clinical development plan supports our near-term objective of submitting an IND for intravenous CAP-1002 as well as provides us with clarity on a path to potential product registration,” Capricor president and CEO Linda Marbán, Ph.D., stated in the news release.
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About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company developing first-in-class biological therapies. Capricor’s lead candidate, CAP-1002, is a cell-based candidate currently in clinical development for the treatment of Duchenne muscular dystrophy. Capricor is also exploring the potential of CAP-2003, a cell-free, exosome-based candidate, to treat a variety of disorders. For more information, visit www.capricor.com.
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