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Hagens Berman Alerts Capricor Therapeutics, Inc. (NASDAQ: CAPR) Investors to FDA Review Extension for Deramiocel Amid Ongoing Securities Class Action and September 28 Lead Plaintiff Deadline

Key Takeaway: Capricor Therapeutics, Inc. is facing a securities class action as the FDA extends the review period for its investigational therapy, deramiocel, for Duchenne muscular dystrophy. The new decision date is set for November 22, 2026, following a major amendment submission. Investors are encouraged to submit their claims before the September 28 lead plaintiff deadline.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA has extended the review period for deramiocel.
  • Capricor's submission includes new data from the Phase 3 HOPE-3 study.
  • Investors have the opportunity to participate in the class action.

CONCERNS & RISKS

  • The FDA's extension indicates ongoing regulatory scrutiny.
  • The company is facing a securities class action lawsuit.
  • The review delay may impact investor confidence.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+668%
120-day peak, hindsight
Typical move
11.6%
average across 7 past catalysts
Cash runway
~22 mo
Low dilution risk
Lead asset
Deramiocel
Phase 3 · Muscular Dystrophies

Full Press Release Details

SAN FRANCISCO , Sept. 17, 2026 /PRNewswire/ -- Hagens Berman Sobol Shapiro LLP—a national plaintiffs' rights law firm with a premier securities practice group—notifies investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR ) of the upcoming September 28, 2026 lead plaintiff deadline in the ongoing securities class action. This alert follows the U.S. Food and Drug Administration's (FDA) recent decision to extend the review period for Capricor's Biologics License Application (BLA), underscoring the ongoing regulatory and disclosure scrutiny surrounding the company.
Hagens Berman encourages investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR ) who suffered substantial losses to submit your losses now .
View our latest video summary of the allegations: youtu.be/-lnVTKgV6as
FDA Extends BLA Review Following Post-AdCom Submissions
On Aug. 24, Capricor announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for Capricor's lead investigational cell therapy, deramiocel, for the treatment of Duchenne muscular dystrophy (DMD), moving the decision date from August 22, 2026, to November 22, 2026.
The agency classified Capricor's recent submission—which follows a turbulent July 2026 Advisory Committee meeting and includes 24-month open-label extension data from the Phase 3 HOPE-3 study alongside a request to pivot toward a refined indication focused solely on upper limb function—as a major amendment.
Securities Class Action Details & Overview
"We're focused on investors' losses and uncovering the full scope of how management characterized these trial endpoints and undisclosed modification," said Reed Kathrein , the Hagens Berman partner leading the firm's investigation on the claims alleged in the pending suit.
What Affected CAPR Investors Should Do If you purchased or acquired Capricor securities between December 17, 2025, and July 26, 2026 , and suffered significant financial losses, you have until September 28, 2026 , to ask the court to appoint you as lead plaintiff. You do not need to seek lead plaintiff status to share in any potential recovery.
To learn more about your legal options, submit your information to Hagens Berman , visit www.hbsslaw.com/capr , call Reed Kathrein at 844-916-0895 , or email [email protected] .
If you'd like more information and answers to frequently asked questions about the Capricor case and the firm's investigation, read more »
Whistleblowers: Persons with non-public information regarding Capricor should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected] .
About Hagens Berman Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com . Follow the firm for updates and news at @ClassActionLaw .
Attorney Advertising. Prior results do not guarantee a similar outcome in any future case.
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Frequently Asked Questions

What is the reason for the FDA's review extension?

The FDA extended the review period for deramiocel due to a major amendment submission.

What is the new decision date for deramiocel?

The new decision date for deramiocel is November 22, 2026.

What should affected investors do?

Investors should submit their claims before the September 28, 2026 lead plaintiff deadline.

What is the focus of the securities class action?

The class action focuses on management's characterization of trial endpoints and undisclosed modifications.

Last updated: Sep 17, 2026