Edgewise Therapeutics, Inc. reports developments from its muscle disease biopharmaceutical pipeline, including sevasemten for Becker and Duchenne muscular dystrophies and cardiac sarcomere modulators such as EDG-7500 and EDG-15400 for serious cardiac conditions. Company updates commonly cover clinical data presentations, open-label extension findings, trial-program progress, and financial results tied to research and development activity.
Recurring EWTX news also includes scientific-conference participation, Nasdaq inducement equity grants under the 2024 Inducement Equity Incentive Plan, and corporate communications about its focus on muscle physiology, dystrophinopathies, hypertrophic cardiomyopathy, and heart failure.
Edgewise Therapeutics (EWTX) has dosed the first patient in EQUINOX-HFpEF, its Phase 2 trial of EDG-15400 for symptomatic heart failure. The study targets heart failure with preserved ejection fraction (HFpEF), enrolling adults whose left ventricular ejection fraction, a measure of the heart's pumping function, is at least 50%.
The randomized, double-blind, placebo-controlled trial evaluates safety, tolerability, drug exposure and effects on the body. Edgewise expects to enroll approximately 90 adults. Participants will receive once-daily oral EDG-15400 at 25 mg or 50 mg, or placebo, for up to 12 weeks. The company intends the investigational drug to address impaired cardiac relaxation. The trial design and Phase 1 first-in-human data will be presented at HFSA 2026, with presentations scheduled for October 10 and October 12, respectively.
Edgewise Therapeutics (EWTX) granted inducement stock options and restricted stock units to three new non-executive employees on September 30, 2026. The options cover 7,500 shares at an exercise price of $40.60 per share, equal to the grant-date closing price. Restricted stock units cover 3,751 shares.
The awards were granted under the 2024 Inducement Equity Incentive Plan. Options vest 25% on each employee's first start-date anniversary, then 1/48th monthly. Restricted stock units vest one-fourth on each of the first four grant-date anniversaries. Both schedules require continued service. The grants comply with Nasdaq Listing Rule 5635(c)(4).
Edgewise Therapeutics (EWTX) will host an investor webcast on September 22, 2026, to discuss the preclinical pharmacologic profile and mechanism of action of EDG-7500, a first-in-class cardiac sarcomere modulator targeting the regulatory light chain (RLC).
Preclinical models have shown that this RLC-targeting MoA can improve cardiac relaxation while preserving systolic function and cardiac reserve, and early clinical observations in patients with symptomatic hypertrophic cardiomyopathy have been consistent with these findings. The company screened more than 7,000 pharmacologically diverse RLC candidates to identify molecules with positive lusitropic properties without systolic liabilities. A peer-reviewed publication detailing EDG-7500’s MoA is expected later today, with a link to be posted on the Edgewise website. The webcast, accompanied by a slide presentation, will focus on the RLC as a unique target for symptomatic heart failure.
Edgewise Therapeutics (EWTX) granted equity inducement awards to four new non-executive employees on August 31, 2026 under its 2024 Inducement Equity Incentive Plan. The awards consist of stock options to purchase a total of 21,000 shares and restricted stock units (RSUs) covering 10,501 shares of common stock.
The stock options have an exercise price of $41.77 per share, equal to the closing price on the grant date. Each option vests 25% on the employee’s one-year employment anniversary, with the remaining 75% vesting in equal monthly installments over the following three years, subject to continued service. Each RSU award vests in four equal annual installments on the first through fourth anniversaries of the grant date, also subject to continued service. The grants are structured as inducement awards in accordance with Nasdaq Listing Rule 5635(c)(4).
Edgewise Therapeutics (Nasdaq: EWTX) announced that its CIRRUS-HCM Phase 2 trial abstract, featuring 12-week top-line data for cardiac sarcomere modulator EDG-7500 in obstructive and nonobstructive hypertrophic cardiomyopathy, has been selected as a late-breaking science presentation at the ESC Congress 2026 in Munich.
The talk, presented by Anjali Tiku Owens, M.D., is scheduled for Monday, August 31, 2026, 11:30–11:45 am CEST in the session “Transforming the heart: novel therapies for myocardial disease and heart failure,” located in Achgabat (Hall A3). The presentation will be posted on the Edgewise website after delivery.
Edgewise Therapeutics (Nasdaq: EWTX) reported second quarter 2026 results and strategic updates, highlighted by completion in July 2026 of the sale of sevasemten and its muscular dystrophy business to Servier for $1.55 billion upfront and up to $1.1 billion in milestones, totaling potential consideration of $2.65 billion.
According to Edgewise, this transaction strengthens the balance sheet and refocuses the company on its cardiovascular pipeline, including EDG-7500 for hypertrophic cardiomyopathy, EDG-15400 for heart failure with preserved ejection fraction and EDG-003. The company previously announced positive top-line 12-week Phase 2 CIRRUS-HCM data for EDG-7500 and plans a Phase 3 trial initiation in Q4 2026. EDG-15400 completed Phase 1 dosing, with a Phase 2 HFpEF trial expected in the second half of 2026.
Cash, cash equivalents and marketable securities were $460.7 million at June 30, 2026, excluding $1,550.0 million of upfront cash from the Servier deal, implying a pro forma balance of $2,010.7 million before taxes and transaction costs. Q2 2026 R&D expenses were $47.5 million and G&A expenses $14.4 million. Net loss was $57.3 million, or $0.53 per share, versus $36.1 million, or $0.34 per share, a year earlier.
Servier announced it has completed the acquisition of Edgewise Therapeutics' (Nasdaq: EWTX) muscular dystrophy business for up to $2.65 billion. The consideration includes an upfront payment of $1.55 billion and up to $1.1 billion in potential regulatory and commercial milestone payments, following regulatory clearance and customary closing conditions.
The deal brings Servier the late-stage investigational therapy sevasemten, being studied in a pivotal Becker muscular dystrophy (BMD) cohort and in phase 2 for Duchenne muscular dystrophy (DMD), along with Edgewise’s specialist team. According to Servier, this significantly advances its rare neurology pipeline and supports its Servier 2030 ambition. Sevasemten is an oral fast skeletal myosin inhibitor intended to protect unstable muscle in rare muscular dystrophies, areas with high unmet medical need and, in BMD, no currently approved treatments.
Edgewise Therapeutics (Nasdaq: EWTX) completed the sale of sevasemten and its muscular dystrophy business to Servier for $1.55 billion in upfront cash plus up to $1.1 billion in regulatory and commercial milestones, for potential total consideration of $2.65 billion.
According to Edgewise Therapeutics, Servier acquired all sevasemten rights, IP, key agreements, regulatory filings and clinical data, and core muscular-dystrophy employees received offers to transition. Edgewise will now focus on its cardiovascular pipeline (EDG-7500, EDG-15400, EDG-003), with upfront proceeds expected to fully fund EDG-7500 through potential approval and support planned Phase 3 (EDG-7500) and Phase 2 (EDG-15400) trials.
Edgewise Therapeutics (Nasdaq:EWTX) granted inducement stock options on June 30, 2026 to 2 new non-executive employees under its 2024 Inducement Equity Incentive Plan.
The options cover 16,500 shares at an exercise price of $40.63 per share and vest over four years, consistent with Nasdaq Listing Rule 5635(c)(4).
Edgewise Therapeutics (Nasdaq:EWTX) reported positive 12-week Phase 2 Part D CIRRUS-HCM data for EDG-7500 in obstructive and nonobstructive hypertrophic cardiomyopathy.
Patients showed improvements in LVOT gradient, NT-proBNP, KCCQ scores, NYHA class and diastolic parameters, with no LVEF reductions below 50% and generally well-tolerated safety, supporting Phase 3 initiation targeted for Q4 2026.