Core Viewpoint - PepGen Inc. experienced a significant surge in share price, rising 119.55% to $5.84 in after-hours trading following the announcement of an underwritten public offering of common stock and pre-funded warrants [1][2]. Group 1: Public Offering Details - The biotech company based in Cambridge, Massachusetts, has initiated an underwritten public offering, with Leerink Partners and Stifel SF serving as joint book-running managers. The underwriters have a 30-day option to purchase additional shares [2]. - The offering is conducted under a Form S-3 registration statement that was declared effective by the SEC on July 8, 2024 [3]. Group 2: Use of Proceeds - PepGen plans to utilize the net proceeds from the offering to fund ongoing research and clinical development, specifically for the FREEDOM-DM1 and FREEDOM2-DM1 trials targeting neuromuscular diseases. Additional funds will be allocated for working capital and general corporate purposes [4]. Group 3: Market Performance Context - Despite the recent surge, PepGen's stock has faced challenges over the past year, with a decline of 69.11%. The company currently holds a market capitalization of $87.25 million and has an average daily trading volume of 572,850 shares. The stock has fluctuated between a 52-week low of $0.89 and a high of $9.94 [5]. - In regular trading, PEPG closed at $2.66, reflecting a daily increase of 36.41% [5].

Group 1 - PepGen Inc. is a clinical-stage biotechnology company focused on developing next-generation oligonucleotide therapies aimed at treating severe neuromuscular and neurological diseases [1] - The company announced the pricing of an underwritten offering of 31,250,000 shares of its common stock at a public price of $3.20 per share [1] - The aggregate gross proceeds from this offering are expected to be $100 million before deducting any expenses [1]

Group 1 - PepGen Inc. has initiated an underwritten public offering of its common stock [1] - The offering includes pre-funded warrants for certain investors to purchase shares of common stock [1] - The company focuses on developing next-generation oligonucleotide therapies aimed at treating severe neuromuscular and neurological diseases [1]

Core Insights - PepGen Inc. announced positive clinical data from the FREEDOM-DM1 Phase 1 study, showing a mean splicing correction of 53.7% in patients with myotonic dystrophy type 1 (DM1) after a single 15 mg/kg dose of PGN-EDODM1, which is significantly higher than previous results [1][2][5] Clinical Study Results - The FREEDOM-DM1 study achieved all key objectives, demonstrating unprecedented splicing correction with 100% of patients in the 15 mg/kg cohort showing improvement [2][5] - Previous doses of 5 mg/kg and 10 mg/kg resulted in mean splicing corrections of 12.3% and 29.1% respectively, indicating a greater than dose-proportional increase in splicing correction [5] - Muscle tissue concentrations of PGN-EDODM1 also showed greater than dose-proportional increases across the different dosing cohorts [5] Safety and Tolerability - PGN-EDODM1 was generally well-tolerated at the 15 mg/kg dose, with all treatment-related adverse events being mild or moderate and transient [5][6] - No serious treatment-related adverse events were reported, and there were no electrolyte-related adverse events [5][6] Future Developments - PepGen anticipates reporting results from the FREEDOM2-DM1 multiple ascending dose study in the first quarter of 2026, with the 5 mg/kg cohort results expected first [6][9] - The company is also preparing to begin dosing the 10 mg/kg cohort in the same timeframe [6] About PGN-EDODM1 - PGN-EDODM1 is designed to restore normal splicing function of MBNL1, addressing the underlying cause of DM1 by binding to pathogenic CUG repeat expansions [8] - The therapy has received Orphan Drug and Fast Track Designations from the U.S. FDA for the treatment of DM1 [8] About Myotonic Dystrophy Type 1 - DM1 is a progressive disorder affecting skeletal, cardiac, and smooth muscle, with a global prevalence estimated at 1 in 8,000 people [11][12] - The disease can lead to various complications, including myotonia, muscle weakness, and cognitive impairments, significantly impacting life expectancy [12]

Core Insights - After-hours trading in the biotech and therapeutics sector saw significant price movements, particularly among small- and mid-cap companies, driven by clinical updates and strategic announcements [1] Company Summaries - **Cyclerion Therapeutics, Inc. (CYCN)**: Shares surged 48.01% to $4.47 after announcing a strategic relaunch focused on neuropsychiatric therapies, including a licensing agreement with MIT for its treatment-resistant depression program. The stock had closed at $3.02, down 0.66% during regular trading. A Phase 2 trial for the TRD program is expected to start in 2026, with initial data anticipated in 2027 [2][3] - **Clearside Biomedical Inc. (CLSD)**: The stock rose 6.82% to $4.23 after a regular session close of $3.96, despite a 9.79% decline during the day. The increase followed presentations at the EURETINA Congress regarding its Phase 2b ODYSSEY trial for wet age-related macular degeneration. The next key catalyst is the initiation of the Phase 3 trial, incorporating FDA feedback [3][4] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares increased by 11.50% to $0.32 after closing at $0.287, following a 6.61% decline during regular trading. The price action comes ahead of the company's participation in the Lytham Partners Fall 2025 Investor Conference [4][5] - **Acumen Pharmaceuticals, Inc. (ABOS)**: The stock advanced 5.69% to $1.30 after a regular session close of $1.23, despite a 3.91% decline during the day. The company reported that topline data from its Phase 2 ALTITUDE-AD trial is on track for late 2026 and plans to decide on advancing a preclinical candidate in early 2026 [5][6] - **PepGen Inc. (PEPG)**: Shares rose 5.13% to $2.05 after closing at $1.95, following an 8.02% decline during the day. The company completed patient dosing in its Phase 1 FREEDOM-DM1 trial and is on track to report topline data in early Q4 2025 [6][7] - **Corcept Therapeutics Inc. (CORT)**: The stock gained 4.54% to $87.10 after a regular session close of $83.32. The company announced it will present late-breaking data from its Phase 3 ROSELLA trial at the 2025 ESMO Annual Meeting. Two upcoming PDUFA dates were confirmed for relacorilant in hypercortisolism and platinum-resistant ovarian cancer [7][8][9]

Group 1 - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by certain officers and directors of PepGen Inc. [1] - The investigation is focused on whether these breaches have negatively impacted shareholders [1] - PepGen Inc. is listed on NASDAQ under the ticker symbol PEPG [1]

Group 1: Modular Medical Inc. (MODD) - Modular Medical Inc. experienced a significant stock price increase of 30.68% to $0.9150 after completing a clinical study for its MODD1 insulin pump, which aims to simplify diabetes management [1] - The company plans to submit its Pivot pump product to the FDA for clearance in October 2025 [1] - Insider activity has been notable, with executives purchasing over $500,000 worth of shares, contributing to heightened trading volume of over 4.5 million shares, significantly above the average of around 200,000 [2] Group 2: Galectin Therapeutics Inc. (GALT) - Galectin Therapeutics Inc. saw its stock rise over 14% to $6.78, continuing a remarkable year-to-date gain of over 360% [3] - The company reached a new 52-week high of $5.99 during intraday trading on September 11, 2025 [3] - CEO Joel Lewis indicated ongoing analysis of additional biomarkers for their lead candidate, belapectin, which is designed to treat MASH cirrhosis and portal hypertension [4] Group 3: Exicure Inc. (XCUR) - Exicure Inc. shares rose 11.11% to $4.00, despite no new company-specific news, indicating speculative interest or technical momentum [5] - The company reported a second-quarter net loss of $2.6 million, wider than the $0.6 million loss in Q2 of 2024, primarily due to higher operating expenses from the acquisition of GPCR USA [6] - Exicure is pursuing new clinical directions, including a completed Phase 2 study of GPC-100 for stem cell mobilization in multiple myeloma patients [6] Group 4: PepGen Inc. (PEPG) - PepGen Inc. rebounded 6.67% to $1.44 after a previous decline, with the movement likely driven by technical factors or speculative interest [6] - The company has shifted focus to PGN-EDODM1 for treating myotonic dystrophy type 1 (DM1) after discontinuing its Duchenne muscular dystrophy program [7] - The FREEDOM-DM1 trial is currently underway, with topline data expected in early Q4 2025, which is considered a key near-term catalyst [8] Group 5: BioSig Technologies Inc. (BSGM) - BioSig Technologies Inc. closed at $6.10 with a sharp gain of 37.08%, followed by a 4.09% rise in after-hours trading to $6.35 [8] - The company has officially rebranded as Streamex Corp., effective September 12, 2025, and will trade under the new ticker symbol "STEX" [8] - The rebranding follows a merger with Streamex Exchange Corp., marking a strategic pivot towards real-world asset tokenization, including an exclusive partnership with Monetary Metals for tokenized, yield-bearing gold products [9]

Core Viewpoint - Biotech stocks are experiencing renewed momentum, with small-cap companies like Nautilus Biotechnology, PepGen, Lixte, RenovoRx, Genelux, and VolitionRx attracting investor interest through various catalysts such as insider buying, strategic partnerships, and clinical trial progress Group 1: Nautilus Biotechnology (NAUT) - Nautilus Biotechnology's stock surged 5.52% during regular trading, closing at $0.7070, and rose an additional 7.5% in after-hours trading to $0.76, with trading volume nearly double its average at 647,399 shares [2] - Recent insider buying by CEO Sujal M. Patel, who purchased 83,500 shares on September 8 and 116,500 shares on September 5, totaling over $135,000, indicates strong leadership confidence [3] - The company reported a narrower loss of $0.12 per share in Q2 2025, with an 18% drop in operating expenses, and has $179.5 million in cash, providing a financial runway through 2027 [4] Group 2: PepGen Inc. (PEPG) - PepGen's stock rebounded 7.14% in after-hours trading to $1.50 after a regular session close of $1.40, with trading volume more than double its average at 638,576 shares [4] - The company completed dosing for its 15 mg/kg arm of the FREEDOM trial, with topline data expected in early Q4 2025, following a strategic narrowing of its pipeline [5] Group 3: Lixte Biotechnology Holdings Inc. (LIXT) - Lixte's stock rose 5.85% in after-hours trading to $5.25 after closing at $4.96, with a trading volume of 503,604 shares, notable given recent volatility [5] - The company announced a $2.6 million purchase of Bitcoin and Ethereum to diversify its treasury holdings, reflecting a strategic shift in financial strategy [6] Group 4: RenovoRx Inc. (RNXT) - RenovoRx shares increased 4.22% in after-hours trading to $1.2194 after a regular session close of $1.17, with trading volume significantly above its average at 886,119 shares [6] - The company received a positive recommendation to continue its Phase III TIGeR-PaC trial for pancreatic cancer, reinforcing confidence in its lead therapy platform [7] Group 5: Genelux Corp. (GNLX) - Genelux's stock rose 4.11% in after-hours trading to $3.80 after closing at $3.65, with trading volume relatively light at 60,339 shares [8] - The recent activity follows Genelux's participation in the H.C. Wainwright Global Investment Conference [9] Group 6: VolitionRx Ltd. (VNRX) - VolitionRx's stock increased 4.27% in after-hours trading to $0.6474 after closing at $0.6209, with trading volume slightly below its average at 183,777 shares [10] - The company announced a Research License and Exclusive Commercial Option Rights Agreement with Werfen's Immunoassay Technology Center, focusing on advancing its Nu.Q NETs assay for Antiphospholipid Syndrome [10]

Core Viewpoint - A class action securities lawsuit has been filed against PepGen Inc. alleging securities fraud that affected investors between March 7, 2024, and March 3, 2025 [1][2]. Group 1: Allegations of Fraud - The lawsuit claims that PepGen's lead product candidate, PGN-EDO51, was less effective and safe than previously represented [2]. - It is alleged that the phase two CONNECT2 study was dangerous or deficient for FDA approval purposes [2]. - The complaint suggests that PepGen was likely to halt the CONNECT2 study, and the clinical, regulatory, and commercial prospects of PGN-EDO51 were overstated [2]. - Defendants' public statements were claimed to be materially false and misleading throughout the relevant period [2]. Group 2: Legal Process and Participation - Investors who suffered losses during the specified timeframe have until August 8, 2025, to request appointment as lead plaintiff [3]. - Participation in the lawsuit does not require serving as a lead plaintiff, and class members may be entitled to compensation without any out-of-pocket costs [3]. Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has extensive expertise in complex securities litigation [4]. - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the U.S. [4].

Core Viewpoint - A class action lawsuit has been filed against PepGen, Inc. for allegedly making materially false and misleading statements regarding its business and the effectiveness of its product PGN-EDO51 during the class period from March 7, 2024, to March 3, 2025 [1][3]. Summary by Sections Lawsuit Details - The lawsuit is filed in the United States District Court for the Eastern District of New York on behalf of all individuals and entities who purchased PepGen securities during the specified class period [1]. - Investors have until August 8, 2025, to apply to the Court to be appointed as lead plaintiff in the lawsuit [1]. Allegations Against PepGen - The complaint alleges that PepGen's management made false and misleading statements about the effectiveness and safety of PGN-EDO51 [3]. - It is claimed that the CONNECT2 study was either dangerous or deficient for FDA approval, leading to the likelihood of halting the study and overstating PGN-EDO51's clinical, regulatory, and commercial prospects [3]. Investor Information - Investors who suffered losses or have questions regarding the lawsuit are encouraged to contact the law firm Bragar Eagel & Squire for more information [4].