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Sep 30
Edgewise Therapeutics Q3 2025 Earnings Report
Edgewise Therapeutics reported its third quarter 2025 financial results and recent business highlights.
Key Takeaways
Edgewise Therapeutics reported a net loss of $40.7 million for the third quarter of 2025, or $0.39 per share, primarily due to increased research and development expenses. The company continues to advance its clinical programs for muscular dystrophies and cardiac conditions, with significant progress in its sevasemten, EDG-7500, and EDG-15400 programs.
Net loss for Q3 2025 was $40.7 million, an increase from $36.1 million in the previous quarter.
Research and development expenses rose to $37.5 million, driven by increased clinical development activities for EDG-15400, EDG-7500, and sevasemten.
Cash, cash equivalents, and marketable securities stood at approximately $563.3 million as of September 30, 2025, providing a strong balance sheet.
The company is building commercial infrastructure for a potential launch of sevasemten in Becker muscular dystrophy, with pivotal trial data expected in Q4 2026.
Edgewise Therapeutics
Edgewise Therapeutics
Forward Guidance
Edgewise Therapeutics is focused on advancing its clinical pipeline, preparing for potential commercial launches, and engaging with regulatory bodies for its key drug candidates.
Positive Outlook
- Pivotal GRAND CANYON cohort of sevasemten in Becker expected to read out in Q4 2026.
- Building commercial infrastructure to support potential launch of sevasemten in Becker.
- MESA open-label extension trial of sevasemten in Becker muscular dystrophy continues to enroll nearly all eligible participants.
- On track to provide program update for Phase 2 CIRRUS-HCM trial of EDG-7500 in Q4 2025, with comprehensive data in H1 2026.
- Initiated Phase 1 healthy adult trial of EDG-15400 for future studies in Heart Failure, with topline results expected in H1 2026.
Challenges Ahead
- Topline data for GRAND CANYON trial is not expected until Q4 2026, indicating a long wait for pivotal results.
- Phase 3 study for Duchenne with sevasemten is planned to initiate in 2026, still in early stages of pivotal trials.
- Comprehensive data for CIRRUS-HCM trial not expected until H1 2026.
- EDG-15400 is in Phase 1, indicating a long development pathway ahead.
- The company has not generated any revenue to date and relies on substantial additional capital.