Snapshot from Aug 25, 2026 at 07:00 UTC. For live data and tracking: View Live
Events / Regulatory / Capricor Securities Class Action Lawsuit
Regulatory class action

Capricor Securities Class Action Lawsuit

Analysis based on 6 articles · First reported Aug 18, 2026 · Last updated Aug 25, 2026

Sentiment
-60
Attention
2
Articles
6
Market Impact
General
Live prominence charts, article sentiment distribution, and event development timeline available on the Ergen Dashboard
Market Impact

The FDA's negative assessment of Capricor's statistical analysis and the subsequent class action lawsuit have severely damaged investor confidence, leading to a 64% drop in Capricor's stock price. The lawsuit and regulatory scrutiny may further pressure the company's valuation and its ability to obtain approval for Deramiocel.

Biotechnology Pharmaceuticals
Event Summary

Kahn Swick & Foti, LLC (KSF) and its partner, former Louisiana Attorney General Charles Foti, announced a class action securities lawsuit against Paragon Therapeutics, Inc. (NasdaqGS: CAPR). The lawsuit, filed in the United States — United States District Court for the Southern District of California, seeks to recover losses for investors who purchased Capricor securities between December 17, 2025 and July 26, 2026. The complaint alleges that Capricor and certain executives failed to disclose material information, violating federal securities laws. The case stems from the FDA's July 27, 2026 publication of briefing documents ahead of an advisory committee meeting to review the Biologics License Application for Capricor's lead product candidate, Deramiocel. The FDA found that Capricor made changes to the pre-specified statistical analysis plan (SAP) without prior FDA review or agreement, and considered the post-study analyses to be post-hoc and exploratory. The FDA also noted an unfavorable benefit-risk profile for Deramiocel. Following this news, Capricor's stock fell 64% to close at $7.00 per share on July 27, 2026. Investors have until September 28, 2026 to request lead plaintiff appointment.

Key Actions
100 United States — Food and Drug Administration released briefing documents Paragon Therapeutics
90 Paragon Therapeutics changed statistical analysis plan
80 Kahn Swick & Foti filed class action lawsuit Paragon Therapeutics
Entities Involved
priv
Paragon Therapeutics
Capricor is the defendant in the class action lawsuit and the subject of FDA criticism regarding its statistical analysis plan. The company's stock plummeted 64% following the FDA's briefing documents, and it faces potential legal liabilities and regulatory hurdles for its lead product candidate.
Importance 100.0 Sentiment -90.0
govactor
United States — Food and Drug Administration
The FDA published briefing documents critical of Capricor's statistical analysis plan and raised concerns about the benefit-risk profile of Deramiocel. This regulatory action triggered the stock drop and the subsequent lawsuit, and it may influence the advisory committee's decision on the BLA.
Importance 80.0 Sentiment -20.0
priv
Kahn Swick & Foti
Kahn Swick & Foti is the law firm representing investors in the class action lawsuit against Capricor. The firm benefits from the case through potential legal fees and settlements, and its reputation is enhanced by pursuing securities litigation.
Importance 70.0 Sentiment 20.0
govactor
United States — United States District Court for the Southern District of California
The court is where the class action lawsuit is pending. It will determine the outcome of the case, including class certification and any potential settlement or judgment.
Importance 50.0 Sentiment 0.0
per
Charles Foti
Charles Foti, a partner at Kahn Swick & Foti and former Louisiana Attorney General, is involved in the class action lawsuit as a partner of the firm. His involvement adds credibility to the case.
Importance 40.0 Sentiment 10.0
per
Lewis Kahn
Lewis Kahn is the Managing Partner at Kahn Swick & Foti and is the contact person for investors in the class action lawsuit. He plays a key role in soliciting investors and managing the case.
Importance 30.0 Sentiment 10.0
Relationships
Paragon Therapeutics related ↔ United States — Food and Drug Administration
United States — Food and Drug Administration related ↔ Kahn Swick & Foti
United States — Food and Drug Administration related ↔ Lewis Kahn
Kahn Swick & Foti related ↔ United States — United States District Court for the Southern District of California
Kahn Swick & Foti related ↔ Charles Foti
Kahn Swick & Foti related ↔ Lewis Kahn
United States — United States District Court for the Southern District of California related ↔ Charles Foti
United States — United States District Court for the Southern District of California related ↔ Lewis Kahn
Charles Foti partner ↔ Lewis Kahn Charles Foti is a partner at Kahn Swick & Foti, LLC, a prominent securities litigation law firm where Lewis Kahn serves
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