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BUZZ-PepGen falls on clinical hold notice from FDA for mid-stage muscle disorder trial

Reuters
Dec 16, 2024
BUZZ-PepGen falls on clinical hold notice from FDA for mid-stage muscle disorder trial

** Shares of drug developer PepGen PEPG.O fall 27.4% to $3.40 premarket

** Co receives clinical hold notice from the US FDA regarding its mid-stage muscle disorder trial

** The FDA indicated they will provide an official clinical hold letter to the company within 30 days- PEPG

** The study was testing co's experimental drug, PGN-EDO51, in a 25-week clinical trial in patients with Duchenne muscular dystrophy

** Duchenne muscular dystrophy is a condition that causes skeletal and heart muscle weakness that quickly gets worse with time

** "We intend to work closely with the FDA to address their questions on our application to initiate CONNECT2 as expeditiously as possible," - PEPG

** Co says it continues to test PGN-EDO51 in the mid-stage trial in the 10 mg/kg group

** Up to last close, stock 31.2% YTD

(Reporting by Sneha S K)

((Sneha.SK@thomsonreuters.com;))

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