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Capricor Therapeutics reports deramiocel cell therapy slows Duchenne muscular dystrophy progression by 47%, improves cardiac function, with mild adverse events. Plans FDA discussions for BLA in Q3 2024, Phase III data expected Q4 2024. Potential to transform DMD treatment, impacting market and healthcare costs.

Capricor Therapeutics' deramiocel cell therapy shows sustained safety and efficacy over three years for Duchenne muscular dystrophy (DMD), slowing disease progression by 47% and improving cardiac function. Adverse events were mostly low grade. Capricor plans to discuss BLA filing with the FDA in Q3 2024, with Phase III data expected in Q4 2024.

Capricor Therapeutics reports positive 3-year results from the HOPE-2 OLE study of deramiocel (CAP-1002) for Duchenne treatment, showing improved cardiac measures and safety. Plans to expedite FDA BLA filing. PPMD optimistic about deramiocel's potential. Data to be presented at PPMD’s Annual Conference.

Capricor Therapeutics reports 3-year HOPE-2 OLE study results showing deramiocel (CAP-1002) improves skeletal muscle and cardiac function in Duchenne muscular dystrophy patients. Significant benefits in upper limb function and cardiac measures observed. Pre-BLA meeting with FDA planned for Q3 2024 to expedite BLA filing.

Capricor Therapeutics plans to meet with the FDA to discuss deramiocel, a cell therapy for Duchenne muscular dystrophy (DMD), aiming for BLA approval. The therapy, promoting heart health, may complement existing treatments. A Phase 3 trial is underway, with results expected soon.

Capricor Therapeutics announced a Pre-BLA meeting with the FDA in Q3 2024 for deramiocel (CAP-1002) to treat Duchenne Muscular Dystrophy (DMD), aiming to finalize BLA filing plans. The company also plans to present HOPE-2 OLE 36-month data at the PPMD Annual Conference. DMD, a severe genetic disorder, lacks a cure, highlighting the need for innovative treatments like deramiocel.

CAP-1002, an investigational cell therapy by Capricor Therapeutics, aims to improve muscle strength and heart health in Duchenne muscular dystrophy (DMD) patients through intravenous infusion. It uses cardiosphere-derived cells to promote muscle repair, reduce inflammation, and inhibit scarring. Currently in Phase 3 trials, CAP-1002 has shown promise in slowing disease progression and improving cardiac function, with ongoing studies to confirm its efficacy and safety.

Pfizer's phase III study on fordadistrogene movaparvovec for Duchenne muscular dystrophy (DMD) failed primary and key secondary endpoints. The therapy aimed to improve motor function in boys aged 4-8. Despite safety concerns, Pfizer plans to share detailed results soon. Sarepta Therapeutics leads the DMD treatment market.

Capricor Therapeutics' CAP-1002 shows sustained benefits in arm and heart function for Duchenne muscular dystrophy (DMD) patients after three years in the HOPE-2 OLE study. The Phase 3 HOPE-3 trial results are anticipated by end of 2024, aiming for FDA approval. CAP-1002, derived from donor heart tissue, has received multiple designations to expedite its development.

Capricor Therapeutics reported positive 3-year results from the HOPE-2 study of CAP-1002 for Duchenne Muscular Dystrophy, showing benefits in skeletal muscle function and cardiac function stabilization. Results were shared with the FDA, supporting CAP-1002's long-term impact and safety profile.