HOUSTON, TX – The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Diakonos’ dendritic cell vaccine DOC1021 for malignant glioma. If the therapy is approved, the US-based immuno-oncology company is eligible for a potential seven years of market exclusivity in newly diagnosed or refractory glioblastoma multiforme,...
treatment News
NEW YORK, NY and WALTHAM, Mass. – Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today announced the initiation of the Phase 2 MaGic trial of DNTH103 in patients with generalized Myasthenia Gravis. The...
LEXINGTON, Mass. – Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced interim results from the four completed active-treatment dose cohorts (0.1, 1.0, 3.0 and 6.0 mg/kg) of its Phase 1 double-blind, placebo-controlled, randomized trial of belcesiran, an investigational GalXC™ RNAi therapeutic...
LEXINGTON, Mass. – Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced top-line results from its PHYOX4 study designed to evaluate the safety and tolerability of a single subcutaneous dose of nedosiran, Dicerna’s late-stage investigational GalXC™ RNAi therapeutic candidate in development for...
LEXINGTON, Mass. – Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, announced it has initiated patient dosing in the Company’s Phase 2 ESTRELLA trial of belcesiran, an investigational GalXC™ RNAi therapeutic candidate for the treatment of alpha-1 antitrypsin (AAT) deficiency-associated liver...
New York, NY – MSK multiple myeloma specialist Sham Mailankody, MBBS has led trials showing that CAR T cell therapy targeting an antigen called GPRC5D appears to be safe and effective against the disease. Results published in the New England Journal of Medicine in September 2022 showed that 71% of patients responded to the GPRC5D-directed...
WATERTOWN, Mass. — Disc Medicine, Inc. a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bitopertin for patients aged...
WATERTOWN, Mass. — Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to DISC-3405 for the treatment of...
WATERTOWN, Mass. — Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the APOLLO post-marketing...
WATERTOWN, Mass. — Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced positive feedback from its pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) to discuss the...