Edgewise submits phase 3 protocol for heart drug EDG-7500 - Investing.com
Investing.com · Nov 5, 1:41 PM
Edgewise Therapeutics Announces Productive End-of-Phase 2 Meeting with FDA for EDG-7500 in HCM; Phase 3 Protocol Features Tolerability-Based Dose Escalation Without Safety Echo Monitoring - PR Newswire
PR Newswire · Nov 5, 1:00 PM
Edgewise Therapeutics Reports Third Quarter 2026 Financial Results - PR Newswire
PR Newswire · Nov 4, 9:01 PM
Market reactionShares rose 16% on Nov 6.
Edgewise Therapeutics is a clinical-stage company developing oral heart drugs, led by EDG-7500 for hypertrophic cardiomyopathy and EDG-15400 for heart failure with preserved ejection fraction; neither is approved.
Edgewise sold sevasemten and its muscular dystrophy business to Servier in July 2026 for $1.55 billion upfront and is now a cardiovascular company. Its case rests on EDG-7500, an oral cardiac sarcomere modulator for hypertrophic cardiomyopathy, with positive Phase 2 results in June and a Phase 3 set to start in Q4 2026. Cash was about $2.01 billion pro forma with the sale proceeds, before taxes and costs.
Thesis checklist
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Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: The EDG-7500 Phase 3 starts in Q4 2026
Does the Phase 3 start on schedule with a design that can show differentiation?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
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With $1.55 billion from selling sevasemten, Edgewise starts an EDG-7500 Phase 3 in hypertrophic cardiomyopathy this quarter
Sevasemten sale to Servier funds EDG-7500 through approval; Phase 2 HCM win now carries the entire cardiovascular pivot
Sevasemten sold for $1.55B upfront, leaving EDG-7500 as a well-funded but Phase 2-stage HCM bet against an already-approved rival
EDG-7500's Phase 2 HCM win sets up a Phase 3 registration bet in a market already contested by approved myosin inhibitors from BMS and Cytokinetics
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
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Disease areas: Obesity, diabetes and heart disease
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
11 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.