Capricor Therapeutics Inc (NASDAQ:CAPR)

Capricor Announces Positive Outcomes from Comprehensive Multidisciplinary Meeting with FDA
GlobeNewswire•January 22, 2019

FDA Provides Positive Feedback on Design for HOPE-2 Clinical Trial

LOS ANGELES, Jan. 22, 2019 (GLOBE NEWSWIRE) -- Capricor Therapeutics (CAPR), a clinical-stage biotechnology company, today announced that it had positive outcomes in its comprehensive multidisciplinary meeting with the U.S. Food and Drug Administration (FDA) regarding development of the company’s novel cell therapy candidate, CAP-1002, to treat Duchenne muscular dystrophy.

Capricor met with the FDA in December 2018, as part of the expedited review afforded under the Regenerative Medicine Advanced Therapy (RMAT) designation which the FDA granted to CAP-1002 in February 2018. The FDA grants the RMAT designation to investigational regenerative medicine therapies intended to treat a serious condition and for which preliminary clinical evidence indicates a potential to address unmet medical needs for that condition.

During the meeting discussion and in subsequent meeting minutes, Capricor asked whether the FDA would agree to its current clinical trial, HOPE-2, serving as the registration study, if HOPE-2 provides evidence that CAP-1002 is safe and effective in treating Duchenne muscular dystrophy. The FDA advised Capricor to request an end of phase meeting after completion of the trial to determine whether HOPE-2 could serve as the registration study.