PepGen Inc. (NASDAQ:PEPG) shares are trading lower during the premarket session on Thursday following regulatory updates regarding its FREEDOM2 trial.
FDA Setback
The U.S. Food and Drug Administration (FDA) on Wednesday placed the company’s FREEDOM2-DM1 trial on a partial clinical hold due to questions regarding preclinical pharmacology and toxicology studies.
The Phase 2 study is a multiple ascending dose trial of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1).
The partial clinical hold did not cite any questions regarding blinded clinical data from the Phase 1 FREEDOM study previously submitted to the FDA in order to initiate the FREEDOM2 study in the U.S.
As part of its ongoing dialogue with the FDA, PepGen is submitting additional analyses, including the recently unblinded FREEDOM data.
In September 2025, PepGen released clinical data from the 15 mg/kg dose cohort of its ongoing FREEDOM-DM1 Phase 1 single ascending dose (SAD) study in DM1 patients.
PEPG Shifted Focus On Myotonic Dystrophy Type 1
PepGen, in May 2025, voluntarily discontinued the development of PGN-EDO51 and wound down all Duchenne muscular dystrophy-related research and development activities.
The decision was based on the levels of dystrophin protein measured in the 10 mg/kg cohort of its CONNECT1-EDO51 study of PGN-EDO51 in DMD patients amenable to exon 51 skipping.
Trial Approval In Other Countries
However, PepGen has received regulatory clearance to initiate the FREEDOM2 study in South Korea, Australia, and New Zealand, with dosing of the 10 mg/kg cohort continuing in the U.K. and Canada.
In addition, PepGen expects to report data from the 5 mg/kg cohort of FREEDOM2 in the first quarter of 2026 and from the 10 mg/kg cohort in the second half of 2026.
PepGen’s Technical Analysis
The stock is currently trading 25% below its 20-day simple moving average (SMA) and 30% below its 100-day SMA, indicating a bearish trend in the short to medium term.
Over the past 12 months, shares have decreased significantly and are currently positioned closer to their 52-week lows than highs, reflecting ongoing challenges.
The RSI is at 50.00, which is considered neutral territory, suggesting that there is no immediate momentum in either direction.
Meanwhile, MACD is at -0.10, below its signal line at 0.05, indicating bearish pressure on the stock.
The combination of neutral RSI and bearish MACD suggests mixed momentum, reflecting uncertainty in the stock’s immediate outlook.
- Key Resistance: $7.50
- Key Support: $4.50
Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $13.25. Recent analyst moves include:
- Oppenheimer: Initiated with Outperform (Target $15.00) (Feb. 25)
- Guggenheim: Buy (Raises Target to $7.00) (Feb. 18)
PEPG Price Action: PepGen shares were down 14.20% at $5.80 during premarket trading on Thursday, according to Benzinga Pro data.
Photo by Tada Images via Shutterstock
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