Capricor Therapeutics Plunges 69% to $6.09 as FDA Questions Duchenne Therapy Data
Updated
Updated · Benzinga · Jul 27
Capricor Therapeutics Plunges 69% to $6.09 as FDA Questions Duchenne Therapy Data
2 articles · Updated · Benzinga · Jul 27
Summary
Capricor shares fell 69.09% to $6.09 in Monday premarket trading after FDA briefing documents cast doubt on its lead Duchenne muscular dystrophy therapy.
The agency's documents questioned whether deramiocel's data meet the FDA standard for substantial evidence of effectiveness, undermining the company's approval case.
Deramiocel's application relies on a single pivotal Phase 3 trial, a setup that suggests regulators may view the overall evidence package as too thin.
The selloff signals investor concern that FDA skepticism could jeopardize approval prospects for Capricor's key program.