By Sabela Ojea

PepGen said Tuesday that it is withdrawing its prior guidance on the timeline to initiate a Phase 1 study of Pgn-Edodm1 to treat the muscle disease myotonic dystrophy type 1.

Shares dropped 9.5% to $12 in after-hours trading. The stock had gained nearly 11% to close at $13.26 during the regular session, after closing at a near-two-month low on Monday.

The clinical biotechnology company has paused additional regulatory filings for clearance to initiate the Phase 1 study to address the official hold letter it awaits from the Food and Drug Administration.

"We will continue to work closely with the FDA to lift the clinical hold whilst we remain fully committed to initiating a Phase 1 study of Pgn-Edodm1 as quickly as feasible," President and Chief Executive James McArthur said.

Myotonic dystrophy is a genetic disorder that causes progressive muscle weakness.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

(END) Dow Jones Newswires

June 13, 2023 16:52 ET (20:52 GMT)

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