The wait that Duchenne families were told might stretch has now been given a date. The Food and Drug Administration has pushed back its decision on the cell therapy Deramiocel from August 22 to November 22, 2026, using a specific regulatory mechanism that carries consequences.
Capricor Therapeutics announced the extension of its target action date, saying the agency classified its recent submission as a major amendment, a designation that by rule adds three months to the review clock. The Center for Biologics Evaluation and Research accepted the amendment for review, citing the significant unmet medical need in Duchenne muscular dystrophy.
