Investors can contact the law firm at no cost to learn more about recovering their losses LOS ANGELES, Aug. 14, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Edgewise Therapeutics, Inc. (“Edgewise Therapeutics” or “the Company”) (NASDAQ: EWTX) investors that the firm has initiated an investigation into possible securities fraud and may file a class action on behalf of investors. Edgewise Therapeutics investors that lost money on their investment are encouraged to contact Lesley Portnoy, Esq. Investo ...

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Edgewise Therapeutics and its officers or directors, following a significant stock price drop after clinical trial data was deemed insufficient for accelerated FDA approval [1][3]. Group 1: Company Overview - Edgewise Therapeutics, Inc. is publicly traded on NASDAQ under the ticker EWTX [1]. - The company is focused on developing treatments for Becker and Duchenne muscular dystrophies, with its lead asset being sevasemten [3]. Group 2: Recent Developments - On June 26, 2025, Edgewise reported clinical trial data for sevasemten, which it described as "positive," but the FDA indicated that the data was insufficient for accelerated approval [3]. - Following the announcement, Edgewise's stock price decreased by $1.27, or 8.86%, closing at $14.33 per share [3]. Group 3: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of advocating for victims of securities fraud and corporate misconduct [4].

Group 1 - Edgewise Therapeutics is under investigation for potential securities fraud or unlawful business practices involving its officers and/or directors [1] - The company reported clinical trial data for its lead asset, sevasemten, indicating "positive" results for Becker and Duchenne muscular dystrophies, but the FDA deemed the data insufficient for accelerated approval [2] - Following the announcement, Edgewise's stock price decreased by $1.27 per share, or 8.86%, closing at $14.33 per share [3] Group 2 - Pomerantz LLP is a prominent firm specializing in corporate, securities, and antitrust class litigation, with a history of recovering multimillion-dollar damages for victims of securities fraud and corporate misconduct [4]

Becker Muscular Dystrophy (BMD) - Sevasemten shows positive observations in Becker patients with continued dosing[12] - A positive Type C FDA meeting offers a clear path to potential approval for Sevasemten[12] - The GRAND CANYON trial is on track for topline data in Q4 2026[12], with >98% power to deliver a statistically significant difference in NSAA vs placebo[20] - In the CANYON study, the NSAA score between the Sevasemten group and the placebo group showed a difference of +1.12 at month 12[27] - In the MESA open-label study, 99% of eligible participants are currently enrolled[30] - Natural history modeling reveals that 92% of CANYON participants improved vs their predicted scores[39], and 89% of ARCH participants achieved higher NSAA scores vs predicted[42] Duchenne Muscular Dystrophy (DMD) - In the LYNX & FOX trials, Sevasemten treatment reduced the functional decline in Duchenne patients[15] - A path to Phase 3 is open with the selection of 10 mg as the target dose[16] - In Duchenne patients, a -82% change in TNNI2 was observed in the 30mg cohort at Month 3[72] - In the FOX study, participants are an average of 11 years old and 4 years out from receiving gene therapy[99] Financial Status - Edgewise has approximately $624 million in cash, cash equivalents, and marketable securities as of March 31, 2025, providing a cash runway through 2028[112][113]

Summary of Edgewise Therapeutics (EWTX) Conference Call Company Overview - **Company**: Edgewise Therapeutics (EWTX) - **Event**: 2025 Conference on May 20, 2025 Key Points on EDG-7500 in Hypertrophic Cardiomyopathy (HCM) 1. **Efficacy Profile**: EDG-7500 shows a unique efficacy profile with no changes in ejection fraction despite increased drug concentration, indicating a differentiated mechanism of action [3][6][10] 2. **Symptomatic Benefits**: 70% of patients became asymptomatic according to New York Heart Association (NYHA) classifications, with KCCQ scores improving by an average of over 20 points [6][9] 3. **Mechanism of Action**: The drug directly addresses hypertrophy without lowering ejection fraction, improving diastolic function and patient symptoms [5][6] 4. **Clinical Observations**: The absence of a placebo arm raised questions, but the deepening response at higher doses supports the drug's efficacy [7][8] 5. **Ejection Fraction Stability**: No relationship was found between drug concentration and changes in ejection fraction, reinforcing the drug's safety profile [10][12][15] 6. **Atrial Fibrillation Cases**: Four cases of atrial fibrillation were noted, but extensive preclinical studies showed no correlation with the drug's mechanism [16][19] 7. **Patient Enrollment Strategy**: Future trials will involve stricter patient selection criteria to minimize risks associated with atrial fibrillation [20][21][23] 8. **Titration Scheme**: The company is exploring a titration scheme that allows for individualized dosing based on patient response rather than relying solely on ejection fraction measurements [28][30][33] Upcoming Data Expectations 1. **Twelve-Week Data**: Anticipated trends in NT proBNP levels and potential deepening of efficacy in non-obstructive patients [25][27] 2. **Individualized Treatment Goals**: The aim is to achieve optimal dosing for each patient based on symptom relief and biomarker normalization [29][33] Sevasemten and DMD Data 1. **Patient Breakdown**: Upcoming data will include approximately 60-70 patients in the LINX group and 20-30 in the FOX group, focusing on biomarker and functional outcomes [38][39] 2. **Long-Term Efficacy**: Observations from previous studies indicate that benefits from gene therapy may diminish after two years, highlighting the need for ongoing assessment [40][41][42] 3. **FDA Discussions**: The company is on track for discussions regarding accelerated approval for Becker by the end of the quarter [44] Conclusion - Edgewise Therapeutics is advancing its clinical programs with a focus on individualized treatment strategies and robust data collection to support the efficacy and safety of its therapies in HCM and DMD. The upcoming data releases and regulatory discussions are critical for the company's future trajectory.