PepGen Inc. is facing a federal securities class action lawsuit filed on behalf of investors who purchased shares between March 7, 2024, and March 3, 2025. The complaint alleges that the company and its executives made materially false and/or misleading statements and/or failed to disclose critical information regarding its lead product candidate, PGN-EDO51.
The lawsuit claims that PGN-EDO51 was less effective and safe than investors were led to believe, and that the CONNECT2 study was dangerous or otherwise deficient for U.S. Food and Drug Administration (FDA) approval. It further alleges that PepGen was likely to halt the CONNECT2 study, and PGN-EDO51's clinical, regulatory, and commercial prospects were overstated.
The complaint references several events, including the July 30, 2024, announcement of CONNECT1 data where dystrophin increase was below expectations, the December 16, 2024, FDA clinical hold on CONNECT2, and the January 29, 2025, updates on safety concerns in CONNECT1 and FDA questions for CONNECT2. The May 28, 2025, discontinuation of the DMD programs is cited as the culmination of these issues.
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