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-0.260355029585799 -0.260355029585799 -0.165680473372781 -0.155325443786982 -0.177514792899408 -0.207573964497041 -0.164201183431953 -0.178994082840237
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PepGen Announces Regulatory Updates on FREEDOM2 [Yahoo! Finance]

PepGen Inc. (PEPG) 
Company Research Source: Yahoo! Finance
- Received regulatory clearance to initiate FREEDOM2 in South Korea, Australia, and New Zealand and dosing of the 10 mg/kg cohort continues in the UK and Canada - - PepGen reiterates guidance for reporting data from the FREEDOM2 5 mg/kg cohort in Q1 2026 and from the 10 mg/kg cohort in 2H 2026 - BOSTON, March 04, 2026 BUSINESS WIRE )--PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies to treat severe neuromuscular and neurological diseases, today announced regulatory updates related to the FREEDOM2 trial. The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the FREEDOM2-DM1 Phase 2 multiple ascending dose (MAD), randomized, placebo-controlled clinical trial of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1). The partial clinical hold questions raised by FDA relate to previously submitted preclinical pharmacology and toxicology studies. The partial clinical hold di Show less Read more
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