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 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.
2 days ago
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.
2 days ago
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.
2 days ago
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.
2 days ago
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.
3 days ago
Edgewise Therapeutics Announces Positive Interim Safety Results for EDG-7500 in Phase 2 CIRRUS-HCM Trial
EWTX
New Projects/Investments
- Edgewise Therapeutics announced positive interim safety results from Part D of its ongoing CIRRUS-HCM Phase 2 clinical trial for EDG-7500, a novel cardiac sarcomere modulator for hypertrophic cardiomyopathy.
- EDG-7500 was generally well tolerated and demonstrated a favorable safety profile, with no clinically meaningful reductions in Left Ventricular Ejection Fraction (LVEF) or LVEF below 50% observed, as of the December 23, 2025 data cutoff.
- The company remains on track to deliver full 12-week Part D readout in Q2 2026 and plans to initiate Phase 3 trials in Q4 2026.
Dec 24, 2025, 1:00 PM
Edgewise Therapeutics Provides Updates on EDG 7500 and Becker Muscular Dystrophy Clinical Programs
EWTX
New Projects/Investments
Guidance Update
- Edgewise Therapeutics' Phase 3 trial for Becker muscular dystrophy completed enrollment in February 2025, with a readout anticipated in November or December of 2026. Previous CANYON readout showed positive results for biomarkers creatine kinase and TNNI2.
- For EDG 7500 in HCM, the company reconfirmed in April 2025 that there was no relationship between drug concentration and ejection fraction (LVEF), a key differentiator from other HCM therapies that could eliminate the need for extensive echo monitoring and expand market access.
- Following an atrial fibrillation (AFib) safety signal, Edgewise implemented a multi-pronged patient evaluation approach for Part D of the EDG 7500 study, aiming for AFib rates in the single digits (2%-8%) consistent with placebo in other Phase 3 trials.
- Further data for EDG 7500's Part D, focusing on safety, will be disclosed in December 2025, with efficacy data for the 25 mg dose from Parts B and C also expected then. Full efficacy data for Part D is projected for the first half of 2026, and a Phase 3 trial start is planned for Q4 2026.
Dec 3, 2025, 8:55 PM
Edgewise Therapeutics Provides Updates on Becker Muscular Dystrophy Phase 3 and EDG-7500 HCM Program
EWTX
New Projects/Investments
Guidance Update
- Edgewise Therapeutics (EWTX) completed enrollment for its Phase 3 trial for Becker muscular dystrophy in February 2025, with a readout expected in November or December 2026. The CANYON study for Becker patients previously hit its primary biomarker endpoint and showed statistical significance on an on-target biomarker.
- For EDG-7500 in hypertrophic cardiomyopathy (HCM), the company reconfirmed in April 2025 that it observed no changes in ejection fraction relative to drug concentration, a key differentiator from other treatments. Robust efficacy data was also reported, including significant improvements in KCCQ scores and NT-proBNP.
- Following a safety signal with atrial fibrillation (AFib) in earlier data, EWTX implemented protocol changes for EDG-7500 to reduce risk, including a multi-pronged echo evaluation and stricter patient selection criteria.
- An update on EDG-7500 is expected in December 2025, focusing exclusively on safety data from at least 20 patients in the 12-week Part D study. The company aims to avoid the need for echo monitoring in a commercial setting for EDG-7500.
- EWTX anticipates starting the Phase 3 trial for EDG-7500 in Q4 2026.
Dec 3, 2025, 8:55 PM
Edgewise Therapeutics Updates on Key Clinical Programs and Milestones
EWTX
New Projects/Investments
Guidance Update
- Edgewise Therapeutics highlighted significant accomplishments in 2025, including the CANYON readout for Becker muscular dystrophy patients in December, which was the first controlled study in this population and met its primary biomarker endpoint.
- The Phase 3 trial for Becker muscular dystrophy completed enrollment in February 2025, with results anticipated in November or December 2026.
- For EDG 7500 in HCM, April 2025 data reconfirmed no changes in ejection fraction relative to drug concentration, demonstrating a differentiated mechanism.
- Following a safety signal with atrial fibrillation (AFib) in the EDG 7500 trial, the company implemented multi-pronged protocol changes to better evaluate patient risk, and an update on Part D safety data is expected in December 2025.
- Efficacy data for EDG 7500's 25 mg dose cohort will be disclosed in the first half of 2026, with a Phase 3 trial projected to start in Q4 2026.
Dec 3, 2025, 8:55 PM
Edgewise Therapeutics Provides Updates on Clinical Programs and Future Milestones
EWTX
New Projects/Investments
Guidance Update
- Edgewise Therapeutics (EWTX) plans to disclose additional data for its 7500 series study in December 2025, focusing on 25 mg dose data over 28 days showing no effects on ejection fraction. Further efficacy data for the 7500 series, including at least 40 patients from Part D, is expected in the first half of 2026.
- The company emphasizes that its 7500 series mechanism is a partial inhibitor that does not impact ejection fraction, differentiating it from CMIs and potentially expanding the market by allowing use by community cardiologists due to reduced monitoring requirements.
- Edgewise aims to kick off Phase 3 development for the 7500 series in Q4 2026, with discussions with the FDA planned for Q2 2026 to align on trial specifics and to demonstrate the drug's safety profile to potentially avoid REMS.
- For its 15,400 program in HFpEF, healthy volunteer data is expected in H1 2026, with a Phase 2 study planned for H2 2026. The pivotal Grand Canyon study for Becker is expected to read out in Q4 2025.
Dec 2, 2025, 7:00 PM
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