PepGen muscular dystrophy drug gets ‘surprise' hold from FDA [Yahoo! Finance]
PepGen Inc. (PEPG)
Company Research
Source: Yahoo! Finance
Dive Brief: PepGen is in a holding pattern on its request to include U.S. patients in a Phase 2 trial of a muscle disorder treatment after the Food and Drug Administration put a partial halt on the study. The agency did not raise any questions about the company's data in patients with the condition known as myotonic dystrophy type 1, or DM1, instead focusing on previously submitted preclinical work, PepGen said Wednesday. Specifically, the FDA seems concerned about drops in blood pressure in a study of mice that have not been seen in humans, analysts wrote. PepGen said it's working with the FDA to address the concerns as quickly as possible. The company is continuing its Phase 2 work elsewhere and recently got permission to open the “Freedom2” study to patients in New Zealand, Australia and South Korea. PepGen shares fell almost 20% Thursday. Dive Insight: The timing of the FDA's action is confusing because the agency has had the mouse data since mid-2024, Stifel analyst Pa
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PEPG
News
- PepGen Inc. Shareholders Are Encouraged to Reach Out to Johnson Fistel for More Information About Potentially Recovering Their LossesGlobeNewswire
- PepGen: Stock Slides On FDA Study Hold - I'm Firmly On The Sidelines [Seeking Alpha]Seeking Alpha
- PepGen GAAP EPS of -$0.27 beats by $0.12 [Seeking Alpha]Seeking Alpha
- US FDA puts partial clinical hold on PepGen's muscle disease drug trial [Yahoo! Finance]Yahoo! Finance
- PepGen Announces Regulatory Updates on FREEDOM2 [Yahoo! Finance]Yahoo! Finance
PEPG
Earnings
- 3/4/26 - Beat
PEPG
Sec Filings
- 3/6/26 - Form 4
- 3/6/26 - Form 4
- 3/6/26 - Form 4
- PEPG's page on the SEC website