Earnings summaries and quarterly performance for Edgewise Therapeutics.
Executive leadership at Edgewise Therapeutics.
Kevin Koch
Detailed
President and Chief Executive Officer
CEO
Alan Russell
Detailed
Chief Scientific Officer
Behrad Derakhshan
Detailed
Chief Operating Officer
Joanne Donovan
Detailed
Chief Medical Officer
John Moore
Detailed
General Counsel
Michael Nofi
Detailed
Chief Financial Officer
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 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.
1 day ago
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.
1 day ago
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.
1 day ago
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.
3 days ago
Edgewise Therapeutics Outlines Upcoming Clinical Data Readouts and Strategic Appointments
EWTX
New Projects/Investments
Board Change
Guidance Update
- Edgewise Therapeutics (EWTX) is set to disclose additional 28-day data at the 25 mg level for its 7500 series study in December 2025, which will demonstrate the absence of ejection fraction effects regardless of drug concentration.
- Further efficacy data for the 7500 series study, including at least 20 patients' safety data from Part D and 40 total patients' data, is anticipated in the first half of 2026. The company plans to initiate a Phase 3 trial in Q4 2026, following discussions with the FDA in Q2 2026.
- Healthy volunteer data for 15,400 (HFpEF) is expected in the first half of 2026, with a Phase 2 study planned to kick off in the second half of 2026.
- The pivotal Grand Canyon study for Becker muscular dystrophy is scheduled to read out in Q4.
- Chris Martin, who has experience with a successful drug launch, has been added to the board to support the commercial buildup for Becker and HCM.
3 days ago
Edgewise Therapeutics Appoints Christopher Martin to Board of Directors
EWTX
Board Change
Hiring
New Projects/Investments
- Edgewise Therapeutics, Inc. (EWTX) appointed Christopher Martin to its Board of Directors on November 20, 2025.
- Mr. Martin is a biotechnology veteran with proven success across all key commercial functions, including marketing, sales, and business development.
- His commercial expertise and launch leadership are considered critical as Edgewise prepares for its first commercial launch in Becker muscular dystrophy and advances its cardiovascular asset to Phase 3.
- Prior to joining Edgewise, Mr. Martin served as Chief Commercial Officer for Verona Pharma, which was acquired by Merck & Co. for approximately $10 billion in October 2025.
Nov 20, 2025, 1:00 PM
Edgewise Therapeutics Provides Updates on 7500 HCM Program, Outlines HFpEF and DMD Strategies
EWTX
New Projects/Investments
Product Launch
- Edgewise Therapeutics reported that its 7500 drug for HCM showed dramatic changes in feel and function (NYHA, KCCQ scores) and robust changes in biomarkers (NT-proBNP) in initial April disclosures, with no relationship between ejection fraction changes and drug concentration.
- The company has implemented protocol amendments for its 7500 program, including internal echo reviews and dosing 25 mg patients in PART-B/C, and has 20 sites open for the PART-D three-month study, with an update expected later in the year.
- For its HFpEF program, Edgewise plans to initiate a three-month Phase 2A study in 2026, with the primary measure being NT-proBNP, aiming for a 20% decrease to indicate clinical benefit.
- In the Duchenne Muscular Dystrophy (DMD) program with Sarasantan, Edgewise is discussing primary endpoints, favoring SV95, with the FDA and EMA and plans to work towards commercialization.
- Edgewise Therapeutics has $560 million in the bank, providing a financial runway through 2028.
Nov 11, 2025, 1:30 PM
Edgewise Therapeutics Provides Updates on HCM, HFpEF, and DMD Programs, Reports Strong Cash Position
EWTX
New Projects/Investments
Guidance Update
- Edgewise Therapeutics (EWTX) is actively screening patients for the PART-D study of 7500 in HCM, with screening starting in June and an update expected later in the year. The drug is noted for not causing ejection fraction changes and demonstrating robust improvements in patient function and biomarkers.
- The company plans to commence a three-month Phase 2A study for HFpEF in 2026, aiming for a 20% decrease in NT-proBNP as a key efficacy measure. Data from healthy volunteer studies for this program is anticipated in H1 2026.
- For its Sarasantan (DMD) program, EWTX is engaging with the FDA and EMA to align on primary endpoints, favoring SV95, and is awaiting the Grand Canyon readout in Q4 2026 before proceeding with a Phase 3 study.
- Edgewise Therapeutics maintains a strong financial standing with $560 million in cash, which is projected to sustain operations through 2028. The company also views the commercialization of its DMD medicine as a multi-billion dollar opportunity.
Nov 11, 2025, 1:30 PM
Edgewise Therapeutics Updates on Clinical Programs and Financial Outlook
EWTX
New Projects/Investments
Guidance Update
- Edgewise Therapeutics (EWTX) reported spectacular initial data for its 7500 program in HCM, showing no relationship between ejection fraction changes and drug concentration, and dramatic improvements in feel and function (NYHA, KCCQ scores) and biomarkers like NT-proBNP. The company has addressed initial atrial fibrillation (AF) cases by refining patient screening and is conducting a 25 mg dose study and a three-month Part D study, with an update expected later in the year.
- The 7500 program demonstrated 25-point changes in KCCQ (placebo-adjusted) within four weeks at a fixed dose, significantly higher than the 7-point changes observed with CMIs, suggesting potential for greater efficacy due to its differentiated mechanism as a partial myosin ATPase modulator.
- For its HFpEF program, Edgewise plans to initiate a three-month Phase 2A study in 2026, with the primary focus on achieving a 20% decrease in NT-proBNP, which is considered a strong indicator of clinical benefit.
- Regarding its sevasemten program for Duchenne Muscular Dystrophy (DMD), Edgewise is in discussions with the FDA and EMA regarding primary endpoints for a registration study, favoring the highly quantitative SV95 wearable device. The company is awaiting the Grand Canyon study readout in Q4 2026 before proceeding with Phase III investment.
- Edgewise Therapeutics has a strong financial position with $560 million in the bank, projected to fund operations through 2028, and plans to pursue commercialization of its DMD medicine, identifying it as a multi-billion dollar global opportunity.
Nov 11, 2025, 1:30 PM
Edgewise Therapeutics Reports Q3 2025 Financial Results and Clinical Pipeline Updates
EWTX
Earnings
New Projects/Investments
Guidance Update
- Edgewise Therapeutics reported a net loss of $40.7 million or $0.39 per share for the third quarter of 2025, with cash, cash equivalents and marketable securities of $563.3 million as of September 30, 2025.
- The company anticipates topline data from the pivotal GRAND CANYON cohort of sevasemten in Becker muscular dystrophy in Q4 2026 and is preparing commercial infrastructure for a potential launch.
- An update for the Phase 2 CIRRUS-HCM trial of EDG-7500 is expected in Q4 2025, and the Phase 1 trial for EDG-15400 in heart failure, initiated in Q3 2025, is projected to yield topline results in H1 2026.
- For Duchenne muscular dystrophy, the LYNX trial identified a 10 mg dose for Phase 3 in June 2025, with plans to initiate a pivotal study in 2026.
Nov 6, 2025, 1:00 PM
Quarterly earnings call transcripts for Edgewise Therapeutics.
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