CAPR Stock Alert: Capricor Therapeutics, Inc. Reports Q2 Earnings Amid Ongoing Securities Class Action Lawsuit - Hagens Berman

Following Capricor's recent Q2 2026 earnings release and conference call—notable for an omission of management Q&A with analysts—the company is facing uncertainty amid an active securities fraud class action.

Capricor's recent Q2 2026 financial report and investor conference neglected to address investor concerns regarding its ongoing legal and regulatory pressures. Management reported a net loss of $40.7 million, alongside $237.9 million in cash and marketable securities. Uniquely, Capricor did not hold a live question-and-answer session with analysts at the end of the earnings call. Management cited the sensitivity of ongoing, real-time discussions with the FDA regarding their regulatory path as the reason for skipping analyst Q&A, and thus management did not address questions about the trial data integrity or legal fallout.

The lawsuit alleges that Capricor and certain executives made materially false and misleading statements regarding the clinical trial data and regulatory pathway for its lead product candidate, Deramiocel, intended to treat Duchenne muscular dystrophy (DMD). Specifically, defendants allegedly failed to disclose that they adopted changes to the pre-specified statistical analysis plan (SAP) without agreement from the U.S. Food and Drug Administration (FDA) prior to resubmitting its Biologics License Application (BLA).

On December 3, 2025 Capricor announced "Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy." The company's CEO said "HOPE-3 delivered strong and definitive evidence that Deramiocel can meaningfully improve the course of Duchenne muscular dystrophy, demonstrating statistically significant improvements in both skeletal and cardiac function." Driven by these claims, Capricor's share price surged 370% to close up $23.60 on December 3, 2025. The following day, the company launched a public stock offering of approximately 6 million shares priced at $25 per share.

Capricor's public assurances unraveled on July 27, 2026, when the FDA published briefing documents ahead of an Advisory Committee meeting. The documents revealed that Capricor made unagreed-upon post-hoc modifications to its pre-specified Statistical Analysis Plan (SAP). The FDA stated that the HOPE-3 study "did not meet its pre-specified primary and secondary efficacy endpoints showing no statistically significant difference between deramiocel and placebo at 12 months". Capricor shares crashed roughly 64% in a single day to close at $7.00. An Advisory Committee subsequently voted 9–3 against the efficacy of the drug, compounding investor losses.