Earnings summaries and quarterly performance for Edgewise Therapeutics.
Executive leadership at Edgewise Therapeutics.
Kevin Koch
Detailed
President and Chief Executive Officer
CEO
AR
Alan Russell
Detailed
Chief Scientific Officer
BD
Behrad Derakhshan
Detailed
Chief Operating Officer
JD
Joanne Donovan
Detailed
Chief Medical Officer
JM
John Moore
Detailed
General Counsel
MN
Michael Nofi
Detailed
Chief Financial Officer
RB
Robert Blaustein
Detailed
Chief Development Officer
Board of directors at Edgewise Therapeutics.
Research analysts covering Edgewise Therapeutics.
Recent press releases and 8-K filings for EWTX.
Edgewise Therapeutics Reports Q4 and Full Year 2025 Financial Results and Program Updates
EWTX
Earnings
Guidance Update
New Projects/Investments
- Edgewise Therapeutics reported a net loss of $50.2 million or $0.47 per share for the fourth quarter of 2025, compared to a net loss of $40.7 million or $0.39 per share for the immediately preceding quarter.
- As of December 31, 2025, cash, cash equivalents and marketable securities were approximately $530.1 million.
- The company expects to report 12-week data from the CIRRUS-HCM trial for EDG-7500 and Phase 1 healthy adult trial data for EDG-15400 in the first half of 2026.
- Pivotal GRAND CANYON results for sevasemten in Becker muscular dystrophy are anticipated in Q4 2026, with preparations for a potential NDA submission to the FDA planned for the first half of 2027.
1 day ago
Edgewise Therapeutics Reports Q4 and Full Year 2025 Financial Results and Business Highlights
EWTX
Earnings
Guidance Update
New Projects/Investments
- Edgewise Therapeutics reported cash, cash equivalents and marketable securities of $530.1 million as of December 31, 2025.
- For the fourth quarter of 2025, the company's net loss was $50.2 million or $0.47 per share, with Research and development (R&D) expenses of $43.6 million and General and administrative (G&A) expenses of $12.4 million.
- The company expects to report CIRRUS-HCM 12-week data for EDG-7500 and Phase 1 healthy adult trial data for EDG-15400 in the first half of 2026.
- Pivotal GRAND CANYON results for sevasemten in Becker muscular dystrophy are anticipated in Q4 2026, with a potential NDA submission planned for the first half of 2027.
1 day ago
Edgewise Therapeutics Provides Updates on Sevasemten and EDG-15400 Programs
EWTX
Product Launch
New Projects/Investments
Guidance Update
- Edgewise Therapeutics is nearing a Phase 3 readout for its Becker program (sevasemten), with potential for the first drug launch in Becker by Q4 2027 and first full year revenue in 2028.
- The closest catalyst is the Part D data for the hypertrophic cardiomyopathy (HCM) program (sevasemten), covering both obstructive and non-obstructive data, following successful implementation of screening measures that showed no AFib burden.
- The company aims to differentiate its HCM drug by avoiding intensive echo monitoring, based on observed dissociation between LVEF and plasma concentration.
- Edgewise's second cardiac program, EDG-15400, is scheduled to enter Phase 1 in the second half of 2026, with healthy volunteer data expected in Q2 2026 and plans for an HFpEF trial in Q3/Q4 2026.
- Edgewise remains on track to initiate Phase 3 for HCM in Q4 2026 and is building commercial infrastructure in anticipation of future product launches.
Feb 12, 2026, 8:00 PM
Edgewise Therapeutics Provides Updates on Sevasemten and EDG-7500 Programs
EWTX
New Projects/Investments
Guidance Update
Product Launch
- Edgewise Therapeutics expects a Phase III readout for sevasemten in its Becker muscular dystrophy program in Q4 2026, with anticipated approval in Q4 2027 and first full year of revenue in 2028.
- The company will release CIRRUS Part D data for EDG-7500 in hypertrophic cardiomyopathy (HCM) soon, after implementing enhanced screening criteria that demonstrated no AFib burden in over 2,000 screening measures, addressing prior safety concerns.
- EDG-7500 is positioned to be a differentiated treatment for HCM, potentially avoiding intensive LVEF monitoring and black box warnings, and showed 16-point improvements in KCCQ in non-obstructive HCM.
- Edgewise plans to initiate Phase III trials for EDG-7500 in HCM in Q4 2026.
- The second cardiac program, EDG-15400, is scheduled to enter Phase I in H2 2026, with healthy volunteer data anticipated in Q2 2026.
Feb 12, 2026, 8:00 PM
Edgewise Therapeutics Provides Updates on Sevasemten and EDG-15400 Programs
EWTX
New Projects/Investments
Product Launch
- Edgewise Therapeutics anticipates the Phase 3 readout for sevasemten in Becker muscular dystrophy (GRAND CANYON study) in Q4 2026, with a potential commercial launch by Q4 2027 and first full year of revenue in 2028.
- The company is preparing for the upcoming Part D data readout for sevasemten in hypertrophic cardiomyopathy (HCM), having implemented enhanced screening measures to address previous AFib observations, with no AFib burden or relationship to plasma concentration observed in extensive Part D screening.
- In HCM, sevasemten demonstrated strong results in Part D, including 16-point improvements in KCCQ for non-obstructive patients and, in obstructive patients, 89% achieving gradient responses below 30 at rest and below 50 at Valsalva, alongside 23-point KCCQ improvements.
- Edgewise plans to initiate Phase 3 trials for HCM in Q4 2026 and will release healthy volunteer data for its second cardiac program, EDG-15400, in Q2 2026, with Phase 1 initiation for EDG-15400 in HFpEF expected in H2 2026.
Feb 12, 2026, 8:00 PM
Edgewise Therapeutics Highlights Strong Financial Position and Advancing Pipeline with Significant Market Opportunities
EWTX
New Projects/Investments
Guidance Update
Product Launch
- Edgewise Therapeutics concluded 2025 with a strong financial position, reporting ~$563 million in cash, cash equivalents, and marketable securities and no debt, projecting a cash runway through 2028.
- The company achieved positive top-line data for Sevasemten in Becker and Duchenne, and positive top-line data for EDG-7500 in Hypertrophic Cardiomyopathy (HCM) during 2025.
- Key upcoming catalysts include the GRAND CANYON Registrational Cohort Readout for Sevasemten in Becker in H1 2026, followed by NDA Submission in H1 2027, and plans for Phase 3 initiation for EDG-7500 in oHCM & nHCM. The company is poised to become a commercial company in 2027.
- Edgewise is targeting significant market opportunities, with an estimated ~$5 billion total potential Becker market and a ~$10 billion total potential HCM market.
Jan 13, 2026, 4:15 PM
Edgewise Therapeutics Provides Updates on Clinical Programs and Financial Position
EWTX
New Projects/Investments
Guidance Update
- Edgewise Therapeutics (EWTX) reported a strong financial position with $563 million in cash and a runway through 2028, supported by a $200 million capital raise in 2025.
- The company anticipates a pivotal study readout for Sevasemten (Becker Muscular Dystrophy) at the end of 2026, with the Phase 3 study being over-enrolled and highly powered for success in a potential $5 billion market.
- For its cardiovascular asset, EDG-7500 (Hypertrophic Cardiomyopathy), Edgewise expects to report data from the 12-week Part D study in Q2 2026 and plans to initiate Phase 3 trials, targeting a potential $10 billion market.
- Additionally, data for EDG-15400 is expected in Q2 2026, with a trial in HFpEF planned for initiation over the summer of 2026.
Jan 13, 2026, 4:15 PM
Edgewise Therapeutics Provides Updates on Clinical Programs and Financial Position at J.P. Morgan Healthcare Conference
EWTX
New Projects/Investments
Guidance Update
Product Launch
- Edgewise Therapeutics (EWTX) anticipates a readout of pivotal study data for Sevasamtan in Becker Muscular Dystrophy in Q4 2026, with NDA submissions planned for 2027. The Phase 3 study (Grand Canyon) was over-enrolled to 175 patients and is 98% powered for its primary endpoint.
- For its EDG-7500 program in Hypertrophic Cardiomyopathy (HCM), the company expects to report data from the 12-week Part D study in Q2 2026 and plans to initiate Phase 3 studies. This drug is differentiated by its strong safety profile, showing no changes in left ventricular ejection fraction.
- The company reported a strong financial position with $563 million in cash and no debt, providing a runway through 2028, following a $200 million fundraising in 2025.
- Edgewise estimates the market potential for its lead assets, Sevasamtan and EDG-7500, at $5 billion and $10 billion, respectively.
Jan 13, 2026, 4:15 PM
Edgewise Therapeutics Updates on Key Programs and Financial Position
EWTX
New Projects/Investments
Guidance Update
- Edgewise Therapeutics (EWTX) maintains a strong financial position with $563 million in cash, no debt, and a runway through 2028.
- The company anticipates a readout of pivotal study data for Sevasamtan (Becker Muscular Dystrophy) at the end of 2026, with NDA submissions planned for 2027. This program's market potential is estimated at $5 billion.
- For EDG-7500 (hypertrophic cardiomyopathy), Edgewise expects to report 12-week Part D study data in Q2 2026 and plans to initiate Phase 3 studies. This drug is highlighted for its strong safety profile with no changes in left ventricular ejection fraction, differentiating it from competitors, and targets a $10 billion market opportunity.
Jan 13, 2026, 4:15 PM
Edgewise Therapeutics Highlights 2026 Priorities and 2025 Accomplishments
EWTX
New Projects/Investments
Guidance Update
- Edgewise Therapeutics announced key clinical milestones for 2026, including top-line results for sevasemten in Becker muscular dystrophy in Q4 2026 and Phase 2 results for EDG-7500 in hypertrophic cardiomyopathy in H1 2026.
- The company plans to prepare for a New Drug Application submission for sevasemten in Becker in H1 2027 and initiate a Phase 3 trial for EDG-7500 in HCM in H2 2026.
- In 2025, Edgewise strengthened its balance sheet with net proceeds of approximately $200 million from an April public follow-on offering.
Jan 13, 2026, 1:00 PM
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