What Is Behind PepGen Stock Surging 115% In Premarket Trade?

PepGen

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(RTTNews) - Shares of PepGen Inc. (PEPG) were up over 115% at $5.74 in after-hours trading on Wednesday, following encouraging data from the 15 mg/kg dose cohort of its ongoing FREEDOM-DM1 trial.

FREEDOM-DM1 is a multinational, placebo-controlled phase 1 single ascending dose (SAD) study evaluating the safety and tolerability of the company's lead asset PGN-EDODM1 in adult participants with myotonic dystrophy type 1 (DM1). The study included dose cohorts of 5 mg/kg and 10 mg/kg with subsequent dose escalation to 15 mg/kg.

According to the study results reported yesterday, a mean splicing correction of 53.7% was observed in patients receiving 15 mg/kg of PGN-EDODM1. This represents a substantial improvement over previously reported results at lower doses: 12.3% at 5 mg/kg and 29.1% at 10 mg/kg.

Since mis-splicing is the underlying cause of DM1, the company is of the view that high levels of splicing correction have the potential to reverse the underlying molecular defects and produce functional improvements in multiple outcome measures, including myotonia and muscle weakness, in repeat-dose studies.

Myotonic dystrophy type 1, or DM1 (also known as Steinert's disease), is a genetic disorder that causes myotonia (stiff or contracted muscles), muscle weakness, and cardiac and respiratory abnormalities. This disease is estimated to affect 40,000 people in the U.S., 75,000 patients in Europe and 15,000 patients in Japan.

PGN-EDODM1 was also found to be generally well-tolerated at 15 mg/kg, with no serious treatment-related adverse events in the study.

A phase 2 randomized, double-blind, placebo-controlled, multiple ascending dose clinical trial evaluating PGN-EDODM1 in approximately 24 adult participants with DM1, dubbed FREEDOM2-DM1, is underway. The company expects to report data from the first cohort of the FREEDOM2-DM1 trial in the first quarter of 2026.

Following the release of promising FREEDOM-DM1 data, the company has priced an underwritten offering of 31.25 million shares of its common stock at $3.20 per share. The offering, which is scheduled to close on or about September 26, 2025, is expected to generate gross proceeds of $100 million. In addition, the underwriters have a 30-day option to purchase up to 4.69 million additional shares of common stock at the public offering price, less the underwriting discount.

The company intends to use the net proceeds from this offering to support its ongoing research and clinical development efforts, including the FREEDOM-DM1 and FREEDOM2-DM1 clinical trials, as well as for working capital and other general corporate purposes.

PEPG has traded in a range of $0.88 to $9.93 in the last 1 year. The stock closed yesterday's trading at $2.66, up 36.41%.