NIPPON SHINYAKU CO

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 treating DMD cardiomyopathy, with Capricor seeking a priority review to expedite approval.

Capricor Therapeutics submitted a BLA to the FDA for deramiocel, a potential first therapy for DMD cardiomyopathy, triggering a $10M milestone payment from Nippon Shinyaku.

Refoxy Pharma secures $9.58 million to develop IPF drug RP-01 targeting FOXO3. Boehringer Ingelheim plans NDA submission for nerandomilast. Insilico's ISM001-055 and Endeavor's ENV-101 show disease improvement. Vicore's buloxibutid and BMS' BMS-986278 also chart progress. Pliant's bexotegrast mitigates chronic cough in IPF. IPOs and partnerships fuel IPF therapeutic field.

NS Pharma announced leadership changes in its Commercial division, promoting Donald Foy to VP, Commercial, and Jennifer Tamberino to national sales director. The company focuses on rare disease therapies, including VILTEPSO® for Duchenne muscular dystrophy.

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 Orphan Drug and ATMP designations for deramiocel, its DMD treatment, potentially accelerating development and market exclusivity in Europe. The company has initiated a rolling BLA with the FDA, targeting full approval by year-end. Deramiocel, comprising allogeneic cardiosphere-derived cells, has shown immunomodulatory, antifibrotic, and regenerative properties in studies. Capricor continues to explore exosome technology and partnerships for deramiocel's commercialization.

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 received a Buy rating from Jones Trading with a $40 target, spotlighting deramiocel for DMD-CM treatment. Positive feedback and EU approval potential bolster optimism. Capricor, partnering with Nippon Shinyaku, aims for FDA approval by 2025, despite a Q3 2024 net loss of $12.6M. The company is expanding treatment use and manufacturing, supported by a $165M cash balance.