{"id":48971,"date":"2026-07-31T18:05:00","date_gmt":"2026-07-31T16:05:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=b5b3e3bea6262abd81d04d1a0e881c9f"},"modified":"2026-07-31T18:05:00","modified_gmt":"2026-07-31T16:05:00","slug":"law-offices-of-howard-g-smith-encourages-capricor-therapeutics-inc-capr-shareholders-to-inquire-about-securities-fraud-class-action","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=48971","title":{"rendered":"Law Offices of Howard G. Smith Encourages Capricor Therapeutics, Inc. (CAPR) Shareholders To Inquire About Securities Fraud Class Action"},"content":{"rendered":"

BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Capricor Therapeutics, Inc. (\u201cCapricor\u201d or the \u201cCompany\u201d) (NASDAQ: CAPR<\/a>) securities between December 17, 2025 and July 26, 2026<\/b>, inclusive (the \u201cClass Period\u201d). Capricor investors have until September 28, 2026 <\/b>to file a lead plaintiff motion.<\/p>

IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN CAPRICOR (CAPR), CONTACT THE LAW OFFICES OF HOWARD G. SMITH TO PARTICIPATE IN THE ONGOING SECURITIES FRAUD LAWSUIT.<\/b><\/p>

Contact the Law Offices of Howard G. Smith to discuss your legal rights by email at howardsmith@howardsmithlaw.com<\/a>, by telephone at (215) 638-4847 or visit our website at www.howardsmithlaw.com<\/a>.<\/p>

What Happened?<\/b><\/p>

On July 27, 2026, before the market opened, the U.S. Food and Drug Administration (\u201cFDA\u201d) released briefing documents ahead of its July 29 advisory committee (\u201cAdCom\u201d) meeting for the BLA. According to the briefing documents, Capricor made changes to the pre-specified statistical analysis plan (\u201cSAP\u201d) and that the final version \u201cwas not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon.\u201d Critically, the final SAP was created one day before the data was unblinded. The FDA disagreed with the changes made to the SAP, stating that the \u201c<\/b><\/i>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.\u201d As a result, the FDA stated that it \u201cconsiders [Capricor\u2019s] analyses based on the post-study SAP versions to be post-hoc and exploratory.\u201d According to the briefing documents, \u201cthe benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness.<\/b><\/i>\u201d<\/p>

On this news, Capricor\u2019s stock fell $12.70, or 64%, to close at $7.00 per share on July 27, 2026, on unusually heavy trading volume.<\/p>

On July 29, 2026, the AdCom met to discuss the Deramiocel BLA. The next day, Medscape reported that the panel relied on SAP version 1.1 as the \u201cprespecified plan\u201d and, in a non-binding 9-3 vote, the panel \u201cconcluded that the available evidence does not support the efficacy of deramiocel for treating DMD-associated cardiomyopathy.\u201d<\/p>

On this news, Capricor\u2019s stock fell $2.38, or 36%, to close at $4.19 per share on July 30, 2026, on unusually heavy trading volume.<\/p>

What Is The Lawsuit About?<\/b><\/p>

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and\/or misleading statements, as well as failed to disclose material adverse facts about the Company\u2019s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the Company adopted changes to the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel; (2) that the FDA had not agreed to those changes before the Company resubmitted the Deramiocel BLA; (3) that, as a result, there was a significant risk that the FDA could conclude the clinical results did not provide substantial evidence of effectiveness of Deramiocel; (4) that, as a result of the foregoing, there was a substantial risk to regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy; and (5) that, as a result of the foregoing, Defendants\u2019 positive statements about the Company\u2019s business, operations, and prospects were materially misleading and\/or lacked a reasonable basis.<\/p>

Contact Us To Participate or Learn More:<\/b><\/p>

If you purchased Capricor securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us:Law Offices of Howard G. Smith,3070 Bristol Pike, Suite 112,Bensalem, Pennsylvania 19020,Telephone: (215) 638-4847Email: howardsmith@howardsmithlaw.com<\/a>,Visit our website at: www.howardsmithlaw.com<\/a>.<\/p>

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.<\/p> Contacts<\/b>

Law Offices of Howard G. SmithHoward G. Smith, Esquire215-638-4847howardsmith@howardsmithlaw.com<\/a>www.howardsmithlaw.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"

BENSALEM, Pa.–(BUSINESS WIRE)–Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Capricor Therapeutics, Inc. (\u201cCapricor\u201d or the \u201cCompany\u201d) (NASDAQ: CAPR) securities between Decembe…<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-48971","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/48971","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=48971"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/48971\/revisions"}],"predecessor-version":[{"id":48972,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/48971\/revisions\/48972"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=48971"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=48971"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=48971"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}