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Recently, shares of PepGen Inc. soared more than 115% in after-hours trading, reaching $5.74 per share. This surge was mainly due to the impressive results from the 15 mg/kg dose group data of its ongoing FREEDOM-DM1 trial.
FREEDOM-DM1 is a multicenter, placebo-controlled Phase I single ascending dose study designed to evaluate the safety and tolerability of PepGen's lead drug PGN-EDODM1 in adult patients with type 1 myotonic dystrophy (DM1). The study starts with dose groups of 5 mg/kg and 10 mg/kg, and gradually escalates to 15 mg/kg.
According to recent research findings, patients receiving a dose of 15 mg/kg showed an average splice correction rate of 53.7%. This data represents a significant improvement over the 12.3% and 29.1% splice correction rates observed in the previous 5 mg/kg and 10 mg/kg dosage groups, respectively. Since erroneous splicing is the fundamental cause of DM1, the company believes that high levels of splice correction have the potential to reverse molecular defects and lead to various functional improvements, such as alleviating muscle stiffness and weakness, in repeat dose studies.
DM1, also known as Steinert's disease, is a hereditary condition that causes muscle stiffness, weakness, and abnormalities in the heart and respiratory systems. It is estimated that 40,000 people in the United States, 75,000 in Europe, and 15,000 in Japan are affected by this disease. Research has found that the overall tolerance of PGN-EDODM1 at a dose of 15 mg/kg is good, with no serious treatment-related adverse events occurring in the trial.
At the same time, the FREEDOM2-DM1 trial is ongoing. This is a Phase 2 randomized, double-blind, placebo-controlled, multiple-dose escalation clinical trial planned to be conducted in approximately 24 adult DM1 patients. The company expects to announce the first set of data from the FREEDOM2-DM1 trial in the first quarter of 2026.
After the FREEDOM-DM1 data received widespread attention, the company announced the issuance of 31.25 million shares of common stock at a price of $3.20 per share. This underwritten offering is expected to be completed on September 26, 2025, and is anticipated to raise a total of $100 million. Additionally, the underwriters have the option to purchase up to 4.69 million additional shares of common stock at the public offering price less the underwriting discount within 30 days.
The company plans to use the net proceeds from this offering to support ongoing research and clinical development work, including FREEDOM-DM1 and FREEDOM2-DM1, as well as for working capital and other general corporate purposes.
In the past year, the trading price of PEPG has ranged from $0.88 to $9.93. Yesterday, its stock closed at $2.66, up 36.41%. What do you think about this rise? Hey, friends with similar experiences, feel free to leave a comment and chat! 😊