Overview
- Capricor said the FDA indicated it would keep the current deramiocel application under review and evaluate new HOPE-3 data for potential approval.
- HOPE-3 enrolled 105 patients with a primary endpoint in upper-limb function and secondary cardiac measures, with topline readout expected in mid–fourth quarter.
- The July Complete Response Letter cited deficiencies, including manufacturing issues that Capricor now says it has addressed.
- Capricor reported approximately $122.8 million in cash, cash equivalents and marketable securities as of June 30 to support next steps.
- Shares of Capricor rose after the update, as investors reacted to the clearer regulatory pathway for deramiocel.