Overview
- Investors filed a class action, Nkamga v. Capricor (No. 3:26‑cv‑04385), alleging the company hid that it changed the pre‑specified statistical analysis plan (SAP) and did not submit the final SAP to the FDA for review.
- FDA briefing documents released before the advisory committee said Capricor’s post‑study SAP versions were exploratory and criticized conversions between raw and percent change as adding complexity and undermining accuracy.
- The FDA disclosures triggered a roughly 64% drop in Capricor’s share price after the July 27 briefing and a further fall after a July 29–30 advisory committee 9–3 non‑binding vote that found the evidence did not support efficacy for cardiomyopathy.
- Multiple plaintiff law firms are soliciting investors to seek lead‑plaintiff status and remind potential class members that they must move the court by September 28, 2026 to be considered for that role.
- Regulators reopened the BLA review and Capricor submitted additional data with the FDA decision date pushed into November 2026, leaving approval prospects, patient access, and the scope of investor losses unresolved.