PepGen Shares Tumble 18.4% After FDA Issues Hold Notice on Study

By Paul Ziobro

PepGen shares plunged in after-hours trading Tuesday after the biotechnology company said the U.S. Food and Drug Administration issued a clinical hold notice for the study of a drug in patients with myotonic dystrophy, a neuromuscular disease.

PepGen shares were down 18.4% to $12.87 in late trading. Through Tuesday's close, the stock was up about 18% this year.

The Phase 1 study was regarding PGN-EDODM1, which delivers a peptide conjugated antisense oligonucleotide to restore cellular function, according to PepGen.

"We are disappointed to receive a clinical hold notice on our planned PGN-EDODM1 study in the U.S., and we will work closely with the FDA to lift the hold as quickly as possible," PepGen Chief Executive James McArthur said.

The Boston-based company said the FDA plans to provide an official clinical hold letter stating the reasons for the hold within 30 days.

Write to Paul Ziobro at [e-mail]

(END) Dow Jones Newswires

May 30, 2023 17:09 ET (21:09 GMT)

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