Capricor Therapeutics reported top-line Phase III results for deramiocel in Duchenne muscular dystrophy that met both the primary upper-limb functional endpoint and a key cardiac secondary endpoint. The data prompted a dramatic market reaction, with Capricor shares surging sharply as investors priced in an improved approval outlook. The company said the pivotal Hope-3 trial confirmed skeletal and cardiac benefits seen in earlier studies; the dataset will underpin a resubmission strategy to regulators. Capricor concurrently priced a $150 million public offering to support commercialization and additional development, signaling a push to fund regulatory and launch activities. Sponsors and investors will watch regulatory interactions closely; positive Phase III cardiac and functional signals in DMD can materially change the benefit–risk calculus for a condition with limited therapies and high unmet need.
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