NS Pharma, Inc.

NS Pharma announces leadership change: Donald Foy promoted to VP, Commercial, and Jennifer Tamberino to National Sales Director, effective September 9, 2024. The new structure aims to foster growth in the rare disease space in the U.S.

Capricor Therapeutics announced EMA granted Orphan Drug and Advanced Therapy Medicinal Product designations to deramiocel for Duchenne muscular dystrophy, supporting its development in Europe.

Capricor Therapeutics announced EMA granted Orphan Drug and Advanced Therapy Medicinal Product designations to deramiocel for Duchenne muscular dystrophy. These designations offer benefits like market exclusivity and reduced fees, supporting deramiocel's development.

Capricor Therapeutics initiated a rolling BLA submission with the FDA for deramiocel, aiming for full approval to treat DMD cardiomyopathy by end of 2024. Deramiocel, with Orphan Drug and RMAT designations, may qualify for priority review, offering a novel treatment for DMD, a condition with no current approved therapies.

Capricor Therapeutics has started a rolling BLA submission with the FDA for deramiocel, aiming to treat Duchenne muscular dystrophy cardiomyopathy. The submission, potentially eligible for priority review, is expected to be completed by end of 2024. Deramiocel, a novel treatment, has shown promise in preclinical and clinical studies for its immunomodulatory and regenerative effects.

Capricor Therapeutics plans to file a Biologics License Application (BLA) for deramiocel to treat Duchenne muscular dystrophy (DMD) cardiomyopathy, based on existing cardiac and natural history data. The BLA submission is expected by end of 2024, with a rolling submission starting October 2024. Deramiocel has shown potential in clinical trials to attenuate DMD's cardiac implications.

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 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.