US FDA puts partial clinical hold on PepGen's muscle disease drug trial [Yahoo! Finance]
PepGen Inc. (PEPG)
Company Research
Source: Yahoo! Finance
of ?a rare muscle disease drug, sending its shares plunging over 25% ?in extended trading. The drug, PGN-EDODM1, is being tested for myotonic dystrophy type 1, a genetic disease that causes muscles to weaken and tighten over time, making movement and daily ?activities harder. PepGen said ?the health regulator's concerns relate to earlier laboratory and animal studies the company submitted. The agency ?did not flag any safety concerns from patient data generated in an early-stage study. PepGen said it is working with ?the FDA ?to address the questions and ?will submit additional information, ?including newly unblinded data from the earlier study. While the U.S. portion of the trial is on hold, the company has been cleared to open the study in South Korea, Australia and New Zealand. Patients in the UK and ?Canada are already being treated at ?the 10 mg/kg dose, following ?a recommendation from an ?independent safety board to move ahead with ?dose escalation. No patients in
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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 muscular dystrophy drug gets ‘surprise' hold from FDA [Yahoo! Finance]Yahoo! Finance
- PepGen GAAP EPS of -$0.27 beats by $0.12 [Seeking Alpha]Seeking Alpha
- PepGen Announces Regulatory Updates on FREEDOM2 [Yahoo! Finance]Yahoo! Finance
PEPG
Earnings
- 3/4/26 - Beat
PEPG
Sec Filings
- 3/4/26 - Form 8-K
- 3/4/26 - Form S-8
- 3/4/26 - Form 10-K
- PEPG's page on the SEC website