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Press releases published on July 11, 2025
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy
GlobeNewswire
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July 11, 2025
FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 to continue pursuing the indication for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy FDA …
Milestone Pharmaceuticals Announces Proposed Public Offering
GlobeNewswire
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July 11, 2025
MONTREAL, Quebec and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (“Milestone”) (Nasdaq: MIST) today announced that it has commenced an underwritten public offering (the “Offering”) of its common shares, accompanying …
Milestone Pharmaceuticals Announces FDA Acceptance of the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray
GlobeNewswire
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July 11, 2025
New PDUFA Action Date of December 13, 2025 $75 Million Royalty Purchase Agreement Payment from RTW Extended Through 2025 MONTREAL and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) (Milestone) today …
e-therapeutics reduziert Risiken im klinischen Verfahren für GalOmic-Kandidaten ETX-312 dank positiver Ergebnisse in der vorklinischen Phase
GlobeNewswire
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July 11, 2025
ETX-312 wurde in GLP-konformen Toxikologiestudien in überhöhten Dosierungen gut vertragen GMP-konforme Herstellung einer Charge für klinische Studien erfolgreich abgeschlossen Auf Kurs für die Einreichung bei der CTA im vierten Quartal 2025 LONDON, July 11 …
e-therapeutics sécurise le développement clinique de son candidat GalOmic ETX-312 grâce à des données non cliniques positives
GlobeNewswire
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July 11, 2025
ETX-312 bien toléré à des doses élevées lors d’études de toxicologie conformes aux normes BPL Fabrication du lot destiné à l’essai clinique achevée avec succès conformément aux normes BPF Soumission de la demande d’autorisation d’essai clinique en bonne …
Italfarmaco Presents New Cardiac Data for Givinostat at 16th European Paediatric Neurology Society (EPNS) Congress
GlobeNewswire
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July 11, 2025
In total, 11 abstracts on givinostat were accepted for presentation at the Congress, including two for an oral presentation MILAN, Italy, July 11, 2025 – Italfarmaco S.p.A. announced today that new cardiac data for givinostat, a novel histone deacetylase …