Capricor Therapeutics (CAPR) provides regulatory update on deramiocel BLA following FDA review of hope-3 topline data

• FDA requests hope-3 clinical study report for BLA review.
• Co. expects to submit BLA updates in February 2026.
• Expects to submit updates to BLA in February 2026 to support continued FDA review.
• FDA requests full hope-3 report to address CRL.

Capricor Therapeutics' update indicates the FDA's request for the full clinical study report related to their BLA review, as well as their expected timeline for submitting updates in February 2026. This is significant as it suggests the FDA is still engaged in the review process but requires additional data to proceed, potentially impacting the stock's volatility and investor sentiment.