Capricor遭证券集体诉讼招揽，核心负面事实仍是7月FDA文件已披露的Deramiocel审评风险

Did you buy CAPR securities between December 17, 2025 and July 26, 2026?
Affected CAPR Investor Summary
- Who: Capricor Therapeutics, Inc. (NASDAQ: CAPR)
- What: Securities fraud class action lawsuit filed
- Class Period: December 17, 2025 through July 26, 2026
- Deadline to Seek Lead Plaintiff Status: September 28, 2026
- Key Lawsuit Allegations: Material misstatements and/or omissions concerning the company's lead product candidates statistical analysis plan and FDA compliance
- Investor Action: Contact Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) for recovery options
RADNOR, Pa., Aug. 27, 2026 /PRNewswire/ -- Kessler Topaz Meltzer & Check, LLP (www.ktmc.com), a nationally recognized securities litigation law firm, informs investors that a securities fraud class action lawsuit has been filed against Capricor Therapeutics, Inc. (Capricor) (NASDAQ: CAPR) on behalf of those who purchased or acquired Capricor securities between December 17, 2025 and July 26, 2026, inclusive. The lawsuit is filed in the United States District Court for the Southern District of California and is captioned Darren Ngasseu Nkamga v. Capricor Therapeutics, Inc., No. 26-cv-04385 (S.D. Cal.). Investors have until September 28, 2026, to file for lead plaintiff status.
CONTACT KTMC TO DISCUSS YOUR LEGAL RIGHTS:
If you purchased or acquired Capricor securities and have lost money on your investment, please provide your information here: https://www.ktmc.com/capr-capricor-therapeutics-inc-class-action-lawsuit?utm_source=PR_Newswire&utm_medium=pressrelease&utm_campaign=capr&mktm=PR
You can also contact attorney Jonathan Naji, Esq. by calling (484) 270-1453 or by email at [email protected]. There is no cost or obligation to speak with an attorney.
To view the Capricor video on YouTube, click here: https://youtu.be/xW8keG6OOfg
CAPRICOR THERAPEUTICS, INC. CLASS ACTION LAWSUIT - COMPLAINT ALLEGATION SUMMARY:
The complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material facts about the company's business, operations, and prospects. Specifically, Defendants misrepresented and/or failed to disclose that: (1) Capricor had adopted changes to the pre-specified statistical analysis plan used to analyze Deramiocel clinical data; (2) the FDA had not agreed to these changes prior to Capricor resubmitting the Biologics License Application ("BLA"); (3) the absence of agreement created significant risk that the FDA could conclude that the clinical results of Deramiocel did not provide substantial evidence of its effectiveness, risking its chances for approval; and (4) as a result of the foregoing, Defendants' statements about the company's business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.
Why did Capricor's Stock Drop?
On July 27, 2026, the FDA released briefing documents ahead of its July 29 advisory committee meeting for Deramiocel's BLA. The briefing documents revealed that Capricor had made changes to the pre-specified statistical analysis plan and failed to submit the final version to the FDA for review "prior to BLA submission and was not discussed and consequently not agreed upon." The FDA went on to disagree with the changes, stating that the "FDA does not consider the conversion of raw change to percent change and then back to raw change to have been scientifically justified, as it adds complexity and reduces accuracy." The briefing documents continued, detailing that "the benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness." On this news, the price of Capricor stock fell 64%.
WHAT CAPRICOR THERAPEUTICS, INC. INVESTORS CAN DO NOW:
- File to be lead plaintiff by September 28, 2026.
- Contact KTMC for a free case evaluation. All representation is on a contingency fee basis, there is no cost to you.
- Retain counsel of choice or take no action.
THE LEAD PLAINTIFF PROCESS FOR CAPRICOR THERAPEUTICS, INC. INVESTORS:
Capricor investors may, no later than September 28, 2026, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.
Kessler Topaz Meltzer & Check, LLP encourages Capricor investors to contact the firm for more information.
ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP (KTMC):
Kessler Topaz Meltzer & Check, LLP (KTMC) is a leading U.S. plaintiff-side law firm focused on securities-fraud class actions and global investor protection. The firm represents individual investors as well as institutions, such as major pension funds, asset managers, and international investors. KTMC has led some of the largest recoveries in securities litigation and has been recognized by peers and the legal media with numerous accolades, including being recognized in Chambers & Partners USA 2026 as a Band 1 Top Firm in Securities and Class Actions, Legal 500's Tier 1 Rankings for Securities and M&A Litigation, The National Law Journal's Plaintiff's Hot List and Trailblazers in Plaintiffs' Law, BTI Consulting Group's Honor Roll of Most Feared Law Firms, The Legal Intelligencer's Class Action Firm of the Year, Lawdragon's Leading Plaintiff Financial Lawyers, and Law360's Titans of the Plaintiffs Bar. The firm operates globally with offices in Pennsylvania and California. KTMC has recovered over $25 billion for our clients and the classes they represent. The complaint in this matter was not filed by KTMC.
CONTACT:
Jonathan Naji, Esq.
(484) 270-1453
280 King of Prussia Road
Radnor, PA 19087
May be considered attorney advertising in certain jurisdictions. Past results do not guarantee future outcomes.
SOURCE Kessler Topaz Meltzer & Check, LLP