Capricor Therapeutics said it will amend its BLA for deramiocel, seeking approval to improve limb function in Duchenne muscular dystrophy after earlier regulatory setbacks. The update follows the company’s efforts to re-focus FDA attention on primary clinical endpoints after controversy around HOPE-3 trial measures. The potential label strategy shift lifted Capricor shares materially in response to the announcement, but the regulatory pathway remains ahead. Still, the step reflects a concrete attempt to align the submission with the endpoint FDA emphasized previously for the deramiocel decision.