PepGen Faces FDA Partial Hold Amid Ongoing FREEDOM2 Trial

PepGen Inc. ( (PEPG) ) just unveiled an announcement.

On March 4, 2026, PepGen reported fourth-quarter and full-year 2025 results and disclosed that the U.S. Food and Drug Administration had placed a partial clinical hold on the U.S. arm of its Phase 2 FREEDOM2-DM1 trial of PGN-EDODM1, citing questions about preclinical pharmacology and toxicology data rather than clinical findings. The company continues dosing 10 mg/kg cohorts in Canada and the U.K., has expanded trial sites to South Korea, Australia and New Zealand, and is moving forward with open-label extension studies while working with regulators, as Phase 1 data presented at major 2025 and upcoming 2026 conferences showed robust splicing correction, generally favorable safety, and support for its best-in-class aspirations.

Financially, PepGen ended 2025 with $148.5 million in cash, cash equivalents and marketable securities, guiding that this runway should fund operations into the second half of 2027 despite an annual net loss of $89.7 million and modestly lower research and development spending year over year. Recent corporate developments include the appointment of a new Chief Business and Legal Officer and issuance of a key U.S. composition-of-matter patent expected to protect PGN-EDODM1 into 2042, developments that strengthen the company’s legal and intellectual property position as it advances its neuromuscular pipeline under the shadow of the FDA’s partial hold.

The most recent analyst rating on (PEPG) stock is a Buy with a $15.00 price target. To see the full list of analyst forecasts on PepGen Inc. stock, see the PEPG Stock Forecast page.

Spark’s Take on PEPG Stock

According to Spark, TipRanks’ AI Analyst, PEPG is a Neutral.

The score is primarily weighed down by weak financial performance (no revenue, large losses, and significant cash burn) despite a relatively supportive balance sheet. Technical indicators are neutral-to-mixed and do not materially offset fundamentals, while valuation is constrained by negative earnings and the absence of dividend support.

To see Spark’s full report on PEPG stock, click here.

More about PepGen Inc.

PepGen Inc., based in Boston, is a clinical-stage biotechnology company developing next-generation oligonucleotide therapies aimed at treating severe neuromuscular and neurological diseases. Its lead investigational candidate, PGN-EDODM1, leverages the company’s proprietary Enhanced Delivery Oligonucleotide (EDO) platform to target myotonic dystrophy type 1, with global clinical programs underway and U.S. orphan drug status secured.

Average Trading Volume: 638,458

Technical Sentiment Signal: Buy

Current Market Cap: $441.4M

See more insights into PEPG stock on TipRanks’ Stock Analysis page.