Reports Q3 revenue $1.59M, consensus $210,000. "In the third quarter we continued to advance our late-stage clinical development program for CAP-1002 in patients with Duchenne Muscular Dystrophy (DMD), and took important steps toward potential commercialization," said Linda Marban, Capricor’s chief executive officer. "We are encouraged by the growing dataset including the statistically significant and clinically relevant data from the HOPE-2 open label extension trial which we recently presented at this year’s World Muscle Society Congress. These and prior results further support CAP-1002’s ability to improve both skeletal and cardiac muscle functions, which suggest potential disease modification, as well as the long-term safety profile of the therapy. Our main priority now is to continue to advance the ongoing HOPE-3 pivotal Phase 3 clinical trial. Patient dosing is underway and as enrollment progresses, we will continue to work closely with the FDA to define next steps in the regulatory pathway for CAP-1002 and at the request of the FDA, we have submitted the results from our HOPE-2 open label extension for their review. In parallel, we are exploring opportunities for additional strategic partnerships outside of the United States to allow for rapid therapy availability to the global patient community, if approved, and to maximize the value of this asset."
Published first on TheFly
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