The FDA escalated scrutiny of Capricor’s Duchenne muscular dystrophy cell therapy, deramiocel, ahead of its Cellular, Tissue and Gene Therapies Advisory Committee meeting. In briefing materials reviewed by regulators, the agency said it could not identify evidence supporting the Phase 3 objectives, despite Capricor’s earlier claims that endpoints were met. Separately, MapLight Therapeutics’ schizophrenia readout showed positive overall efficacy but disappointed on a once-daily regimen—sending the company’s stock down sharply. MapLight said the twice-daily arm delivered an average improvement of 4.5 points versus placebo on the PANSS-based primary measure, while the once-daily dosing missed the primary endpoint. For investors and clinicians, the juxtaposition underscores how dosage design, trial endpoints, and FDA interpretive frameworks are tightening the bar for neurological and muscle therapies moving through late-stage review.