NIPPON SHINYAKU CO

Capricor Therapeutics submitted a Biologics License Application to the FDA for deramiocel, a cell therapy for Duchenne Muscular Dystrophy cardiomyopathy. The submission, supported by clinical trial data, seeks full approval and a priority review, potentially reducing the review timeline. Deramiocel has shown promise in attenuating DMD's cardiac implications.

Capricor Therapeutics submitted a Biologics License Application to the FDA for deramiocel, a potential first therapy for Duchenne muscular dystrophy cardiomyopathy, triggering a $10M milestone payment from Nippon Shinyaku. Deramiocel has shown promise in clinical trials for attenuating DMD's cardiac effects.

Capricor Therapeutics submitted a BLA for Deramiocel, targeting DMD cardiomyopathy, to the FDA, seeking priority review. Supported by HOPE-2 trial data, it shows potential in improving cardiac and skeletal functions in DMD patients, with a $10M milestone payment from Nippon Shinyaku possible.

Capricor Therapeutics submitted a Biologics License Application to the FDA for deramiocel, a cell therapy for Duchenne muscular dystrophy cardiomyopathy, potentially leading to the first approved treatment for this condition. The company's stock surged 192% in six months, reflecting investor optimism. Capricor anticipates a priority review, which could shorten the FDA's decision time to six months.

Capricor Therapeutics submitted a Biologics License Application to the FDA for deramiocel, a potential first therapy for Duchenne muscular dystrophy cardiomyopathy, triggering a $10 million milestone payment from Nippon Shinyaku.

Capricor Therapeutics submitted a Biologics License Application to the FDA for deramiocel, targeting Duchenne muscular dystrophy cardiomyopathy, triggering a $10M milestone payment. Supported by Phase 2 trial data, it seeks priority review, potentially reducing approval time to 6 months.

Capricor Therapeutics submitted a Biologics License Application to the FDA for deramiocel, targeting Duchenne muscular dystrophy cardiomyopathy, triggering a $10M milestone payment from Nippon Shinyaku. The submission includes Phase 2 trial data, seeking priority review. Deramiocel offers potential immunomodulatory and regenerative benefits for DMD patients.