Favorable FDA feedback on Phase 3 design extends Edgewise rally

 

• Edgewise's November 5 release reported favorable FDA End-of-Phase 2 feedback for EDG-7500.
• Submitted STRATUS-HCM protocol allows tolerability-based escalation without echocardiograms guiding dosing decisions.
• Phase 3 remains scheduled to begin this quarter and enroll roughly 600 adults.
• Raymond James raised its target to $85 Thursday, citing the reduced monitoring burden.
• Thursday shares opened 14.6% higher, then closed up 3.6% on heavy volume.
• Friday's 8.8% rise from open shows renewed regular-session buying, not an overnight gap.
• The 11.2% move exceeds the 8.7% weekly range and nearly doubles monthly norms.
• No newer filing surfaced Friday; the move extends Thursday's regulatory reaction.

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