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PEPG.US
id: 1620

PepGen ($PEPG) Misleading Drug Trial Results, FDA Hold, and DMD Program Collapse Case

Investors can submit applications for the lead plaintiff role.
E.D. New York
Court
1:25-cv-03221
Case number
03/07/2024
Class period Start
03/03/2025
Class period End
08/08/2025
Lead Plaintiff motion deadline
  • $PEPG investors filed a claim against PepGen for overstating the safety and efficacy of its lead Duchenne muscular dystrophy drug PGN-EDO51, while concealing regulatory risks and trial failures.
  • After PepGen disclosed FDA holds, serious safety issues, and ultimately shut down the entire program, $PEPG fell over 60%, including a 32.7% drop on July 30, 2024.
  • $PEPG investors can join this case to be notified about potential recovery.

Case Details:


Between March 7, 2024 and March 3, 2025, PepGen promoted PGN-EDO51 as a leading treatment for Duchenne muscular dystrophy (DMD) and repeatedly emphasized positive trial data from its CONNECT1 and CONNECT2 studies. Executives said the drug showed favorable safety, strong exon skipping results, and regulatory alignment for moving forward.

But internal findings were far more concerning. CONNECT1 showed limited effectiveness and concerning side effects at the 5 mg/kg dose.

On July 30, 2024, PepGen revealed that results were underwhelming, causing a 32.69% drop in $PEPG.

Months later, the FDA issued a clinical hold on CONNECT2 over safety issues.

On January 29, 2025, PepGen disclosed even more serious regulatory concerns and a possible delay in trials, triggering another 21.74% decline.

Finally, on March 4, 2025, PepGen voluntarily paused the CONNECT2 study. The stock dropped 18.86%.

By May 28, 2025, PepGen revealed the drug failed to meet dystrophin production targets, effectively ending its DMD program.

Based on these events, $PEPG investors filed a claim against PepGen, accusing the company of the following:
  • It misled investors about PGN-EDO51’s trial results, safety profile, and efficacy.
  • It failed to disclose FDA concerns and downplayed regulatory risks.
Considering all the representations, investors believe PepGen concealed critical trial failures and regulatory warnings to maintain its valuation and investor confidence.
Case Type
US Securities Class Action
Case Status
Lead Plaintiff Submission
Alleged Offence
Misleading Statements
Failure to Disclose
Omissions
Suspected Party
Directors
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
03/04/2025
Filing date
06/09/2025
Lead Plaintiff Deadline
08/08/2025

PepGen Ltd

PepGen Inc., a clinical-stage biotechnology company, develops oligonucleotide therapeutics for the treatment of severe neuromuscular and neurologic diseases in the United States. Its lead product c...

    Ticker
    PEPG.US
    ISIN
    US7133171055
    CIK
    0001835597
    Sector
    Healthcare
    Industry
    Biotechnology
    Country
    USA
    Address
    321 Harrison Avenue, Boston, MA, United States, 02118