- Trial Phase
- Phase 2
- Time to Market
- 4-6 years (Phase 2 completed; Phase 3 starting Q4 2026; if successful, NDA filing likely 2029-2030 at earliest)
- Why 4/10
- No FDA filing or PDUFA date is scheduled. The next catalyst for EDG-7500 is Phase 3 trial initiation targeted for Q4 2026, which is a programmatic milestone rather than a binary readout. Phase 3 topline data is likely 2+ years away. The stock has already reacted to Phase 2 data (fell ~10% on June 16 despite "positive" results) and the Servier deal restructuring. Per the rubric, a mid-stage drug with no near-term binary catalyst scores 4.
Edgewise is now a cardiovascular-focused single-product company after selling its muscular dystrophy business to Servier for $1.55B upfront. EDG-7500's Phase 2 safety data (no LVEF drops below 50% across all patients) is a genuine differentiator, but efficacy against BMS's approved Camzyos and Cytokinetics' pending aficamten remains unproven. Watch for Phase 3 start in Q4 2026 and any partnership/BD rumors for the program.
Price Chart
Executive Summary
EDG-7500 is Edgewise Therapeutics' lead cardiovascular asset — a novel oral cardiac sarcomere modulator for hypertrophic cardiomyopathy (HCM), a genetic heart disease affecting ~1 in 500 people. Positive 12-week Phase 2 data (June 16, 2026) showed broad clinical improvements across LVOT gradient, NT-proBNP biomarker, and symptom scores, with no patient experiencing LVEF drop below 50% — a clean safety profile that differentiates it from already-approved Camzyos (mavacamten, BMS) and Cytokinetics' aficamten. However, the stock fell ~10% on the readout as the efficacy magnitude disappointed relative to competitors. Edgewise recently sold its muscular dystrophy business to Servier for $1.55B upfront (+ up to $1.1B milestones), fully funding EDG-7500 through potential approval and repositioning the company as a pure-play cardiovascular biotech. Phase 3 starts in Q4 2026. The stock trades at ~$43.69 near its 52-week high, with analyst consensus 'Strong Buy' and mean price target ~$49.
How It Works
EDG-7500 is an oral pill that partially relaxes the heart muscle. In hypertrophic cardiomyopathy (HCM), the heart muscle is too thick and squeezes too hard, which blocks blood flow and makes it hard for the heart to fill properly. EDG-7500 slows down the first part of the heart's contraction and improves relaxation, without weakening the heart's overall pumping strength — a key safety advantage over existing drugs in this class.
Trial Status
Phase 2 CIRRUS-HCM trial (NCT06347159) is active but no longer recruiting. Positive 12-week Part D top-line data announced June 16, 2026 in both obstructive and nonobstructive HCM. Phase 3 program initiation targeted for Q4 2026.
The Two-Sided Case
Upcoming Catalysts
- Phase 3 EDG-7500 program initiation — Q4 2026
- Potential Servier milestone payments from sevasemten GRAND CANYON data (Q4 2026) — though not EDG-7500 specific, this provides cash tailwinds
- Additional HCM medical conference data presentations throughout 2026-2027
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Edgewise Therapeutics, Inc. 8-K EWTX ·Originating report