Capricor Therapeutics Inc

Capricor Therapeutics is amending its Biologics License Application to pursue a narrower upper limb skeletal muscle indication for deramiocel after an FDA advisory committee voted 3 to 9 against the cardiomyopathy indication in Duchenne muscular dystrophy. The HOPE-3 trial's primary endpoint showed a statistically significant slowing of upper limb disease progression, with a 4.5% mean difference favoring the drug and a p-value of 0.029. However, the company's cash and marketable securities fell to $237.9 million as of June 30, 2026, from $318.1 million at the end of 2025, and second-quarter net loss widened to $40.7 million, or $0.70 per share, from $25.9 million, or $0.57 per share, a year earlier. The left ventricular ejection fraction result across all patients was revised under the prespecified statistical model from a 2.4 percentage point difference at p=0.04 down to 1.8 percentage points at p=0.09, weakening a key secondary measure. Short interest stands at 33.72% of float, and the FDA has indicated it will review the coming BLA amendment and extend the PDUFA date accordingly.

Capricor Therapeutics announced plans to amend its Biologics License Application for Deramiocel after an FDA advisory committee voted 3 to 9 against the cardiomyopathy question, with the PDUFA target action date set for August 22. CEO Linda Marbán said the company will submit an amendment including 24-month open-label extension data from the HOPE-3 study and additional analyses, and the FDA has indicated willingness to review it and extend the action date upon receipt. The company also disclosed a statistical model change that shifted the LVEF endpoint from a 2.4 percentage point treatment difference with a p-value of 0.04 to a 1.8 percentage point difference with a p-value of 0.09, while the primary skeletal function endpoint remained statistically significant. Capricor reported cash and marketable securities of approximately $237.9 million as of June 30, 2026, a net loss of $40.7 million or $0.70 per share for the second quarter, and said all non-Deramiocel pipeline work is on hold pending regulatory clarity.

Kaplan Fox & Kilsheimer LLP has filed a class action lawsuit against Capricor Therapeutics on behalf of investors who purchased Capricor securities between December 17, 2025 and July 26, 2026. The complaint alleges that on July 27, 2026, the FDA released briefing documents ahead of an advisory committee meeting for Capricor’s resubmitted Dermamiocel Biologics License Application, revealing that the company made changes to the pre-specified statistical analysis plan without FDA review or agreement. Following the disclosure, Capricor’s stock price fell $12.70, or 64%, to close at $7 per share. Investors have until September 28, 2026 to seek lead plaintiff status.

Hagens Berman has filed a securities fraud class action lawsuit against Capricor Therapeutics, Inc. on behalf of investors who purchased shares between December 17, 2025 and July 26, 2026. The suit alleges that Capricor and certain executives made materially false and misleading statements about clinical trial data and the regulatory pathway for its lead product candidate Deramiocel, intended to treat Duchenne muscular dystrophy. Specifically, defendants are accused of failing to disclose that they adopted changes to the pre-specified statistical analysis plan without agreement from the U.S. Food and Drug Administration prior to resubmitting its Biologics License Application. The complaint points to a July 27, 2026 FDA briefing document which revealed that the HOPE-3 study did not meet its pre-specified primary and secondary efficacy endpoints and that multiple versions of the statistical analysis plan had been generated with modifications to endpoint definitions and analytical methods. Following that disclosure, Capricor shares fell about 64% to close at $7. Investors have until September 28, 2026 to seek lead plaintiff status.

Kahn Swick & Foti notifies Capricor Therapeutics investors that they have until September 28, 2026 to apply for lead plaintiff in a securities class action. The lawsuit covers purchasers of Capricor securities between December 17, 2025 and July 26, 2026, alleging the company failed to disclose that its final statistical analysis plan for lead candidate Deramiocel was not submitted to the FDA before the biologics license application and was finalized one day before data unblinding. On July 27, 2026, after the FDA published briefing documents calling the analyses post-hoc and exploratory and questioning the drug's benefit-risk profile, Capricor's stock fell 64% to $7.00 per share. The case is pending in the United States District Court for the Southern District of California.

Rosen Law Firm has filed a securities class action lawsuit against Capricor Therapeutics on behalf of investors who purchased shares between December 17, 2025 and July 26, 2026. The suit alleges that the company made materially false and misleading statements and failed to disclose that it adopted changes to the pre-specified statistical analysis plan for Deramiocel without prior FDA agreement, creating a significant risk that the agency could find the clinical results insufficient to support effectiveness and deny regulatory approval for Duchenne muscular dystrophy. Investors who wish to serve as lead plaintiff must move the Court no later than September 28, 2026. The Rosen Law Firm notes that it has achieved the largest ever securities class action settlement against a Chinese company and was ranked number one by ISS Securities Class Action Services for number of settlements in 2017.

Bernstein Liebhard LLP announced that a shareholder has filed a securities class action lawsuit on behalf of investors who purchased or acquired Capricor Therapeutics, Inc. securities between December 17, 2025 and July 6, 2026. The lawsuit alleges that defendants made materially false and misleading statements regarding the company's business operations, growth prospects, and financial stability, causing Capricor securities to trade at artificially inflated prices. Investors who suffered large losses are encouraged to contact the firm before the September 28, 2026 lead plaintiff deadline. Bernstein Liebhard has recovered over $3.5 billion for clients since 1993.

Bronstein, Gewirtz & Grossman, LLC has filed a class action lawsuit against Capricor Therapeutics, Inc. and certain officers, alleging violations of federal securities laws. The suit covers investors who purchased or acquired Capricor securities between December 17, 2025 and July 26, 2026. The complaint claims defendants made false and misleading statements and failed to disclose that Capricor changed the pre-specified statistical analysis plan for Deramiocel without FDA agreement, creating a significant risk the FDA would find insufficient evidence of effectiveness and deny approval for Duchenne muscular dystrophy. Investors have until September 28, 2026 to seek lead plaintiff appointment. The firm represents investors on a contingency fee basis.

Bleichmar Fonti & Auld LLP has launched an investigation into Capricor Therapeutics for potential securities fraud following a 64.5% stock drop. The investigation concerns whether Capricor misled investors about clinical data for its lead product candidate Deramiocel, including statements on positive topline results and its regulatory path with the FDA. On July 27, 2026, FDA briefing documents raised concerns about post-hoc changes to Capricor’s statistical analysis plan, specifically alterations to the methodology for calculating the primary endpoint shortly before the database was unlocked. This caused Capricor’s stock to fall $12.70 per share, from a closing price of $19.70 on July 24 to $7.00 on July 27. Investors who held Capricor securities are encouraged to contact the firm to discuss their legal options.

The Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Capricor Therapeutics Inc. following allegations that the company may have issued materially misleading business information. The investigation stems from a July 27, 2026 Reuters article reporting that FDA staff reviewers raised concerns about the effectiveness data for Capricor's cell therapy deramiocel, causing shares to fall 64% that day. The Rosen Law Firm is preparing a class action seeking recovery of investor losses on a contingency fee basis. Investors who purchased Capricor securities are encouraged to contact the firm for information about joining the prospective class action.

Glancy Prongay Wolke & Rotter LLP has launched a securities fraud investigation into Capricor Therapeutics, Inc. following the release of FDA briefing documents that raised concerns about the company's cell therapy deramiocel. The FDA stated that Capricor's method of converting raw change to percent change and back was not scientifically justified, adding complexity and reducing accuracy, and concluded that the benefit-risk assessment for deramiocel appears unfavorable without evidence of effectiveness. Cantor Fitzgerald analyst Kristen Kluska described the briefing documents as painting an ugly picture and raising concerns about data integrity. On July 27, 2026, Capricor shares fell $12.70, or 64.5%, to close at $7.00, and then declined a further $0.42, or 6.08%, to $6.57 on July 29, 2026, after an FDA advisory committee meeting. The law firm is urging investors who suffered losses to contact them about potentially pursuing claims.

Holzer & Holzer, LLC announced an investigation into whether Capricor Therapeutics, Inc. complied with federal securities laws. The investigation follows a July 27, 2026 STATNews report that the FDA said Capricor’s stem cell treatment for Duchenne muscular dystrophy did not meet Phase 3 trial objectives, contrary to the company’s prior claims. Capricor’s stock price dropped after the news. The law firm is encouraging investors who purchased Capricor stock and suffered a loss to contact Corey Holzer or Joshua Karr to discuss their legal rights.

Lowey Dannenberg P.C. is investigating Capricor Therapeutics, Inc. for potential violations of federal securities laws. The investigation follows Capricor's disclosure on July 27, 2026 that FDA briefing materials for its Deramiocel therapy relied on a superseded statistical analysis plan, which the company described as an unsigned, incomplete internal draft, rather than the final version governing its Phase 3 trial results. After this news, Capricor's stock price fell approximately 64%, wiping out hundreds of millions of dollars in shareholder value. On July 30, 2026, an FDA advisory committee voted 3 in favor and 9 against the effectiveness of Deramiocel for treating cardiomyopathy in Duchenne muscular dystrophy, raising further doubts ahead of the August 22, 2026 PDUFA target action date. The law firm is examining whether the company and its executives provided accurate and complete information to investors.

An FDA advisory committee voted that available evidence did not support the effectiveness of Capricor Therapeutics' Deramiocel for treating cardiomyopathy in Duchenne muscular dystrophy patients. The Cellular, Tissue and Gene Therapies Advisory Committee voted 3 in favor, 9 against, with 0 abstentions, on a narrower indication than Capricor had proposed, and the vote is non-binding. The committee did not vote on Deramiocel's overall benefit-risk profile, and its feedback on upper limb function was directionally supportive of clinical evidence from the Phase 3 HOPE-3 trial, including results on the primary endpoint PUL 2.0. Capricor remains confident in the HOPE-3 data and continues to work with the FDA ahead of the August 22, 2026 PDUFA target action date.

Bragar Eagel & Squire, P.C. has launched an investigation into Capricor Therapeutics, Inc. on behalf of its stockholders. The investigation concerns whether Capricor violated federal securities laws or engaged in other unlawful business practices. The inquiry follows a July 27, 2026 STAT News report that the FDA said Capricor's stem cell treatment for Duchenne muscular dystrophy did not meet Phase 3 trial objectives, contrary to the company's prior claims. After the news, Capricor's stock fell $12.70 per share, or approximately 64.5%, to close at $7.00 per share. The law firm encourages investors who suffered losses to contact partners Brandon Walker or Melissa Fortunato to discuss their legal rights.

Kirby McInerney LLP announced an investigation into Capricor Therapeutics over potential securities law violations. The investigation follows a July 27, 2026 FDA briefing document release that questioned the effectiveness of Capricor's lead product candidate deramiocel, noting the application relied on a single pivotal trial rather than the typically required two studies. Capricor's stock fell $12.70 per share, or approximately 64.5%, to close at $7.00 on July 27, 2026. The law firm is examining whether the company or its senior management violated federal securities laws or engaged in unlawful business practices. No lawsuit has been filed, and the investigation is ongoing.