PepGen Receives U.S. FDA Orphan Drug and Rare Pediatric Disease Designations for PGN-EDO51 for the Treatment of Duchenne Muscular Dystrophy
PepGen Inc. (PEPG)
Company Research
Source: GlobeNewswire
BOSTON, March 13, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) granted both orphan drug and rare pediatric disease designations for PGN-EDO51, an investigational therapeutic for Duchenne muscular dystrophy (DMD) patients whose mutations are amenable to an exon 51 skipping approach. PepGen is evaluating PGN-EDO51 for the treatment of DMD in the ongoing CONNECT1 Phase 2 trial, and expects to begin enrolling patients in the CONNECT2 Phase 2 trial later this year. “Receiving these FDA designations for PGN-EDO51 emphasizes the critical demand for novel and enhanced therapeutic options for people living with DMD,” said James McArthur, Ph.D., President and CEO of PepGen. “With our CONNECT1 Phase 2 trial underway, we look forw
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News
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- PepGen Inc. (NASDAQ: PEPG) had its price target lowered by analysts at Wedbush from $21.00 to $20.00. They now have an "outperform" rating on the stock.MarketBeat
PEPG
Earnings
- 11/8/23 - Miss
PEPG
Sec Filings
- 4/26/24 - Form ARS
- 4/26/24 - Form DEF
- 4/16/24 - Form PRE
- PEPG's page on the SEC website