Capricor Therapeutics shares rose 85.04% to $7.79 in Friday premarket trading after the gene therapy company followed second-quarter results with fresh detail on the FDA review of its Deramiocel Biologics License Application, manufacturing readiness and long-term data. The company said it remains actively engaged with the Food and Drug Administration and is awaiting feedback after a Bioresearch Monitoring inspection produced a Form 483 with one observation that it says has been addressed. Capricor's Good Manufacturing Practice facility in San Diego is operational for an initial launch if Deramiocel is approved, while a second-floor expansion is targeted for full validation and FDA inspection in 2027. It also said it has withdrawn a motion for a preliminary injunction against NS Pharma in favor of arbitration, continues to challenge the U.S. distribution pricing structure as harmful to patient access, and has delivered about 1,300 intravenous infusions to more than 200 Duchenne muscular dystrophy patients across three trials, with some treated for more than five years. Capricor reported no revenue and a $0.70 per-share quarterly loss, versus an analyst estimate for a $0.58 loss, and ended June with about $237.9 million in cash, which it said should fund operations for at least the next twelve months. The company has also begun regulatory engagement in Europe and Japan, while plans to study younger Duchenne muscular dystrophy patients, Becker muscular dystrophy and exosome-based programs remain tied to U.S. regulatory clarity.