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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...
CINCINNATI — Shortly after Ryan Dempster and his wife, Jenny, welcomed daughter Riley into the world on April 1, they learned their daughter suffers from DiGeorge syndrome, a rare congenital disease that prevents her from swallowing and digesting food. Dempster has commuted to Childrens Memorial Hospital over the last seven...
Ryan Dempster, a pitcher for the Chicago Cubs, recently opened up to the Chicago Tribune about his new-born daughter and her fight with DiGeorge Syndrome. In the interview, the professional baseball player admitted that the experience has “been rougher than anything I can imagine.” The syndrome is caused by a...
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,...