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Capricor Therapeutics submitted a Biologics License Application to the FDA for deramiocel, targeting Duchenne muscular dystrophy cardiomyopathy, triggering a $10M milestone payment. The submission includes Phase 2 trial data, with hopes for a priority review to shorten the approval timeline.

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.

In 2024, Muscular Dystrophy News Today highlighted key developments in MD research, including gene therapy trials, new treatments like SAT-3247 and Elevidys, and clinical advancements for DMD and FSHD, emphasizing progress in muscle function and dystrophin production.

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 completed its Biologics License Application submission to the FDA for deramiocel, a cell therapy for Duchenne muscular dystrophy cardiomyopathy, supported by Phase 2 trial data. The company seeks a priority review to expedite the approval process.

Capricor Therapeutics submitted a biologics license application for deramiocel, targeting Duchenne muscular dystrophy cardiomyopathy, supported by HOPE-2 trial data showing efficacy and safety. Deramiocel demonstrated potential in reducing cardiac muscle damage and improving cardiac function.

Capricor Therapeutics submitted a Biologics License Application to the FDA for deramiocel (CAP-1002) to treat Duchenne muscular dystrophy cardiomyopathy, supported by Phase 2 trial data. They seek a priority review to shorten the FDA's review timeline from 10 to 6 months.

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.