Every 8-K that Edgewise Therapeutics, Inc. (EWTX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow EWTX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full EWTX filings page.
Edgewise Therapeutics reported second quarter 2026 results and detailed a major portfolio shift. In July 2026 it completed the sale of sevasemten and its muscular dystrophy business to Servier for $1.55 billion in upfront cash and up to $1.1 billion in additional milestone payments, for aggregate potential consideration of up to $2.65 billion. Cash, cash equivalents and marketable securities were $460.7 million as of June 30, 2026; adding the upfront proceeds from the sale yields a pro forma balance of $2,010.7 million before taxes and transaction-related costs.
The company highlighted positive 12-week Phase 2 CIRRUS-HCM data for EDG-7500 in obstructive and nonobstructive hypertrophic cardiomyopathy and plans to initiate a Phase 3 trial in the fourth quarter of 2026. EDG-15400 completed a Phase 1 study in healthy adults, with a Phase 2 trial in heart failure with preserved ejection fraction expected in the second half of 2026. Research and development expenses were $47.5 million and general and administrative expenses were $14.4 million, contributing to a net loss of $57.3 million, or $0.53 per share, for the quarter. Following the Servier transaction, Edgewise describes itself as a cardiovascular-focused company advancing EDG-7500, EDG-15400 and EDG-003.
Edgewise Therapeutics, Inc. completed the sale of its sevasemten muscular dystrophy program to Servier Pharmaceuticals LLC and Les Laboratoires Servier, receiving $1.55 billion in upfront cash and eligibility for up to $1.1 billion in additional regulatory and commercial milestones, for total potential consideration of $2.65 billion. The disposed assets are treated as a sale of nonfinancial assets under U.S. GAAP and do not qualify as discontinued operations. Edgewise has prepared unaudited pro forma condensed financial information under Article 11 of Regulation S-X to illustrate the effects.
Pro forma as of March 31, 2026, cash and cash equivalents rise to about $1.53 billion, total assets to $2.01 billion, and stockholders’ equity to roughly $1.75 billion, driven by an estimated pre-tax gain of $1,487,621 thousand and after-tax gain of $1,261,765 thousand. For 2025, pro forma results show net income of $1,135,527 thousand and earnings per share of $11.03, compared with a historical net loss of $167,795 thousand and a loss per share of $(1.63). For the three months ended March 31, 2026, the pro forma net loss is $27,937 thousand versus a historical loss of $49,013 thousand, reflecting removal of sevasemten-related expenses.
A Transition Services Agreement requires Edgewise to provide specified services to Servier at below-market rates; $17,880 thousand of consideration is allocated to this obligation and recorded as deferred income, with $5,364 thousand current and $12,516 thousand non-current, recognized in other income as services are performed. The pro forma statements present TSA costs in operating expenses and Servier reimbursements plus deferred income amortization in other income, with no net effect on pro forma earnings for the periods shown.
Edgewise Therapeutics, Inc. completed the sale of its sevasemten compound and muscular dystrophy program to Servier Pharmaceuticals and Les Laboratoires Servier. Servier acquired all related rights and assets for $1.55 billion in upfront cash consideration and up to $1.1 billion in additional milestone payments, for aggregate potential consideration of up to $2.65 billion.
Edgewise states that the transaction strengthens its balance sheet, enhances financial flexibility, and aligns with a strategy to focus on its cardiovascular pipeline, including EDG-7500 for hypertrophic cardiomyopathy, EDG-15400 for HFpEF, and EDG-003. Upfront proceeds, together with existing cash, are expected to fully fund EDG-7500 development through potential approval.
Edgewise Therapeutics, Inc. reported results of its Annual Meeting of stockholders held on June 4, 2026. Stockholders elected three Class II directors — Laura Brege, Badreddin Edris, Ph.D., and Jonathan Root, M.D. — to serve until the 2029 annual meeting, with each to continue until a successor is elected and qualified.
Stockholders also ratified the appointment of KPMG LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, with 99,637,228 votes for, 1,123 against, and 578,031 abstaining. In addition, stockholders approved, on an advisory and non-binding basis, the compensation of the company’s named executive officers, with 87,055,111 votes for, 3,491,326 against, and 577,257 abstaining.
Edgewise Therapeutics entered a definitive agreement for Servier to acquire sevasemten and its muscular dystrophy business for $1.55 billion in upfront cash and up to $1.1 billion in milestones, for potential total consideration of $2.65 billion. The deal is subject to customary conditions, including Hart-Scott-Rodino antitrust clearance, and is expected to close in Q3 2026. Edgewise states the upfront proceeds, together with existing cash, are expected to fully fund EDG-7500 through potential approval and support expansion of its cardiovascular pipeline, which includes EDG-7500 for hypertrophic cardiomyopathy, EDG-15400 for HFpEF and EDG-003. The company plans to report 12-week CIRRUS-HCM Part D data in Q2 2026 and target Phase 3 initiation of EDG-7500 in Q4 2026.
Edgewise Therapeutics reported first quarter 2026 results highlighted by continued investment in its muscle and cardiovascular pipeline and a larger loss. Net loss was $49.0 million, or $0.46 per share, compared with $40.8 million, or $0.43 per share, a year earlier.
Research and development expenses rose to $42.7 million from $36.8 million, and general and administrative expenses increased to $11.5 million from $9.2 million. The company ended March 31, 2026 with $499.6 million in cash, cash equivalents and marketable securities. Edgewise also reported positive long-term sevasemten data in Becker muscular dystrophy and reiterated key upcoming readouts, including GRAND CANYON pivotal data in Becker in the fourth quarter of 2026 and 12-week CIRRUS-HCM data in hypertrophic cardiomyopathy in the second quarter of 2026.
Edgewise Therapeutics reported fourth-quarter and full-year 2025 results alongside major pipeline milestones in muscular dystrophy and cardiovascular programs. Cash, cash equivalents and marketable securities were $530.1 million as of December 31, 2025.
For Q4 2025, research and development expenses were $43.6 million, up from $37.5 million in the prior quarter, driven mainly by higher personnel costs and increased EDG-15400 and EDG-7500 clinical activity. General and administrative expenses rose to $12.4 million from $9.4 million.
The company reported a fourth-quarter net loss of $50.2 million, or $0.47 per share, compared with a net loss of $40.7 million, or $0.39 per share, in the preceding quarter. Edgewise highlighted upcoming catalysts, including GRAND CANYON pivotal data for sevasemten in Becker muscular dystrophy in Q4 2026, CIRRUS-HCM 12-week EDG-7500 data and Phase 1 EDG-15400 data in the first half of 2026.
Edgewise Therapeutics, Inc. (EWTX) reported that its Board of Directors appointed Christopher Martin as a Class I director, with his term running through the company’s 2028 annual meeting of stockholders. Martin, age 49, brings extensive commercial experience from roles at Verona Pharma, SK Life Science, Cempra, and Salix Pharmaceuticals, including leading launch strategies for several first‑in‑class products.
Martin was deemed independent under SEC and Nasdaq rules and has no related‑party transactions requiring disclosure. He will receive an annual cash retainer of $40,000 for board service and a stock option grant with a grant date fair value of approximately $700,000, vesting in equal monthly installments over 36 months, with full vesting upon a Change in Control as defined in the company’s 2021 Equity Incentive Plan.
Edgewise Therapeutics (EWTX) appointed Michael Nofi as Chief Financial Officer, effective November 10, 2025, following the immediate retirement of CFO Michael Carruthers. The company stated Mr. Carruthers’ decision was not due to any disagreement. To support continuity, he is expected to remain an at-will employee until January 31, 2026 and then serve as a consultant until October 31, 2026.
Mr. Nofi brings 30+ years of finance leadership across life sciences, including six years as Chief Accounting Officer at SpringWorks Therapeutics. His compensation includes a $465,000 annual base salary and a target cash bonus equal to 40% of base salary. He will receive a stock option for 262,500 shares vesting 25% after one year and monthly thereafter over three years, and 43,750 restricted stock units vesting in four equal annual installments, each subject to continued service.
Edgewise Therapeutics (EWTX) filed an 8-K stating it furnished a press release announcing its financial results for the third quarter ended September 30, 2025. The press release is attached as Exhibit 99.1 and incorporated by reference.
The company notes that the information provided under Item 2.02 and Item 9.01 (including Exhibit 99.1) is furnished and not deemed filed under the Exchange Act.
Edgewise Therapeutics (Nasdaq:EWTX) filed an 8-K furnishing upbeat interim data on sevasemten for Becker and Duchenne muscular dystrophies and summarizing recent FDA guidance.
- MESA extension (n = 85): 0.8-point NSAA improvement over 18 months, 3-year disease stabilization and 99 % rollover from prior studies.
- Placebo switchers gained 0.2 NSAA points.
- Safety remains favorable after up to three years.
- FDA confirmed NSAA as a meaningful endpoint and indicated the ongoing GRAND CANYON study (topline Q4 2026) could be a single pivotal trial for Becker registration.
- Duchenne Phase 2 LYNX & FOX: Well-tolerated across doses; 10 mg selected for Phase 3 after functional and biomarker benefits.
Management plans a Phase 3 design meeting with FDA in Q4 2025 and expects pivotal Duchenne enrollment in 2026. No financial metrics were disclosed.