Capricor moved to re-position deramiocel after prior setbacks with the FDA, announcing plans to amend its BLA to target improved limb function in Duchenne muscular dystrophy. The company said it expects to file additional data and analysis following the FDA’s willingness to review an updated submission. The strategy shift followed controversy around the HOPE-3 Phase 3 program endpoints, where an FDA advisory committee previously focused on secondary findings. Capricor’s updated goal is narrower than its earlier indication, seeking to align the regulatory narrative with functional benefit. The company’s latest disclosures also prompted renewed investor attention after deramiocel’s earlier complete response letter, as shareholders bet on an FDA-focused pathway correction.