The pair has penned an exclusive, worldwide collab and license deal that will see them develop and, they hope, sell axatilimab, Syndax's anti-CSF-1R monoclonal antibody in chronic graft-versus-host disease (cGVHD) as well as in additional immune-mediated diseases “where CSF-1R-dependent monocytes and macrophages are believed to contribute to organ fibrosis,” according to a statement.
NEW YORK, NY / ACCESSWIRE / August 19, 2021 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today announced that REZUROCK™ (belumosudil) 200 mg once daily (QD) tablets is now commercially available for shipment to prescribed patients in the United States. REZUROCK was approved on July 16, 2021 by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy.
NEW YORK, NY / ACCESSWIRE / August 4, 2021 / Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the National Comprehensive Cancer Network® (NCCN) added REZUROCKTM (belumosudil) tablets to its NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Cell Transplantation (HCT) in the Pre-Transplant Recipient Evaluation and Management of Graft-Versus-Host Disease (GVHD). The NCCN Guidelines in the United States now include REZUROCK with a Category 2A designation as a suggested systemic agent for steroid-refractory chronic GVHD.
The U.S. Food and Drug Administration (FDA) comes through for blood cancer patients experiencing chronic graft-versus-host disease after a bone marrow transplant. On Friday, the agency approved belumosudil as a new treatment option for anyone over 12 with cGVHD after two prior lines of therapy have failed.
Shares in Kadmon Pharmaceuticals were up more than 20% on Friday after the FDA approved its oral kinase inhibitor Rezurock (belumosudil) for chronic graft-versus-host disease (GvHD) in adult and paediatric patients 12 years and older who have failed at least two prior lines of systemic therapy. The company noted the decision makes Rezurock the first FDA-approved small molecule inhibitor of ROCK2, a signaling pathway that modulates inflammatory responses and fibrotic processes.
NEW YORK, NY / ACCESSWIRE / March 10, 2021 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for belumosudil for the treatment of chronic graft-versus-host disease (cGVHD). In a notice received from the FDA on March 9, 2021, the Company was informed that the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of belumosudil has been extended to August 30, 2021.
NEW YORK, NY / ACCESSWIRE / December 6, 2020 / Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced 12-month data from ROCKstar, its ongoing pivotal trial of belumosudil for the treatment of patients with chronic graft-versus-host disease (cGVHD), in an oral session at the 62nd American Society of Hematology (ASH) Annual Meeting.
NEW YORK, NY / ACCESSWIRE / November 4, 2020 / Kadmon Holdings, Inc. (NASDAQ:KDMN) announced today that 12-month data from ROCKstar (KD025-213), the ongoing pivotal trial of belumosudil (KD025) for the treatment of chronic graft-versus-host disease (cGVHD), have been selected for oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting, taking place virtually December 5 - 8, 2020.
NEW YORK, NY / ACCESSWIRE / September 30, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for belumosudil (KD025), the Company's Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, for the treatment of patients with chronic graft-versus-host disease (cGVHD).
Kadmon (NYSE:KDMN) has submitted a marketing application with the FDA for belumosudil (KD025), a Rho-associated coiled-coil kinase 2 inhibitor, for the treatment of patients with chronic graft-versus-host disease (cGVHD).