2023-05-30 17:30:29 ET
- PepGen ( NASDAQ: PEPG ) on Tuesday said its investigational new drug (IND) application to treat a type of muscle wasting disease had been put on a clinical hold by the U.S. Food and Drug Administration (FDA).
- PEPG stock slumped 18.4% to $12.88 after hours.
- The company's IND was to start an early-stage trial with its investigational candidate PGN-EDODM1 in patients with myotonic dystrophy type 1.
- The FDA indicated to the company that it would get an official letter stating the reasons for the clinical hold within 30 days.
- "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," PEPG CEO James McArthur said in a statement .
For further details see:
PepGen stock slides ~18% after hours on FDA clinical hold for DM1 early-stage trial