KING OF PRUSSIA, Penn. — Global biotechnology leader CSL today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for garadacimab (CSL312) as a once-monthly prophylactic treatment for hereditary angioedema (HAE). The company also announced the European Medicines Agency (EMA) has accepted the...
treatment News
SEATTLE – CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has completed a rolling New Drug Application (“NDA”) submission to the U.S. Food and Drug Administration (“FDA”) seeking approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L). CTI had previously announced the...
BOSTON, Massachusetts — Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, announced today the initiation of an investigator sponsored trial (IST) in rGBM at the DFCI with...
CAMBRIDGE, Mass. — Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLN-619 in relapsed/refractory multiple myeloma. CLN-619 is a potential first-in-class humanized IgG1 monoclonal antibody that...
CAMBRIDGE, Mass. — Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today announced new clinical data from its Phase 1 study of CLN-049, a novel, investigational FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory (r/r) acute...
CAMBRIDGE, Mass. — Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today shared updated clinical data from its Phase 1 study of CLN-049, a novel, investigational FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory (R/R) acute...
CAMBRIDGE, Mass. — Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CLN-049 for the treatment of relapsed/refractory (R/R) acute myeloid leukemia...
CLN-978 is the first and only development-stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases Sjögren’s disease represents the third indication under development for CLN-978, and is a disease with high unmet need and no currently approved therapies CAMBRIDGE, Mass. — Cullinan Therapeutics,...
SAN CARLOS, Calif. — CuraSen Therapeutics, Inc., a clinical-stage biopharmaceutical company developing drug candidates with broad applicability in neurodegenerative and neuropsychiatric diseases, today announced dosing of the first patient with CuraAX (CST-3056) in a Phase 2a proof-of-concept trial in neurogenic orthostatic hypotension (nOH). nOH is a serious condition characterized by...
WOODBRIDGE, Conn. — Cure Rare Disease (CRD) announced it has been awarded a $7.4 million grant from the California Institute for Regenerative Medicine (CIRM) to advance the development of a novel gene therapy for Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9), a progressive neuromuscular disorder with limited treatment options. Cure Rare...