Capricor Therapeutics (CAPR) Deramiocel Statistical Analysis Case

Attorneys review the case details to decide whether to proceed with a class action.

S.D. California

Court

3:26-cv-04385

Case number

12/17/2025

Class period Start

07/26/2026

Class period End

09/28/2026

Lead Plaintiff motion deadline

$CAPR stockholders filed a claim against Capricor Therapeutics for touting positive Phase 3 trial results and regulatory momentum toward FDA approval of its lead therapy, Deramiocel, while concealing that it had made undisclosed changes to the clinical trial's statistical analysis plan that the FDA had never agreed to.
After the FDA revealed Capricor's unauthorized statistical analysis changes and an advisory committee panel voted that the data did not support the drug's effectiveness, $CAPR fell a combined 77% over two trading days on July 30, 2026.
$CAPR investors can join this case to be notified about potential recovery.
Case Details:

Between December 17, 2025 and July 26, 2026, Capricor and CEO Linda Marban repeatedly told investors that its Phase 3 HOPE-3 trial for Deramiocel, a cell therapy for Duchenne muscular dystrophy, had achieved statistically significant results on its primary and key secondary endpoints, and that the Company was making strong regulatory progress toward FDA approval, including securing a PDUFA target action date of August 22, 2026.

However, investors allege Capricor made undisclosed changes to the trial's pre-specified statistical analysis plan, including to the primary and key secondary endpoint definitions and analytical methods, and that the final version of this plan was never submitted to the FDA for review or agreed upon before the Company resubmitted its Biologics License Application.

Then, on July 27, 2026, the FDA released briefing documents ahead of its advisory committee meeting, revealing that Capricor's statistical analysis changes had not been agreed to and stating that the "benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness." 

$CAPR fell 64%, closing at $7.00 per share. Additional revelations followed on July 30, 2026, when it was reported that the FDA advisory committee had voted 9-3 that the available evidence did not support the drug's efficacy. 

On this news, $CAPR fell an additional 36%, closing at $4.19 per share, down from a Class Period high of $35.34 reached on April 21, 2026.

Based on these events, $CAPR investors filed a claim against Capricor Therapeutics, alleging the company:
It overstated the strength and regulatory viability of its Deramiocel clinical data.
It hid that it had made unauthorized changes to the trial's statistical analysis plan without FDA agreement.
It concealed the substantial risk that the FDA would find the clinical results did not support the drug's effectiveness.
Investors argue Capricor Therapeutics misled the market about its Deramiocel regulatory prospects, causing losses when the truth emerged.

Case Type

US Securities Class Action

Case Status

Attorney Investigation

Alleged Offence

Misleading Statements,

Failure to Disclose

Suspected Party

Directors,

Management

Security Type

Stocks

Trade Direction

Long

Shock Event Date

07/27/2026

Filing date

07/30/2026

Lead Plaintiff Deadline

09/28/2026