Kadmon Holdings Inc. (NASDAQ: KDMN) has reported its Q2 2021 financial results and offered operational updates.
REZUROCK approved for cGVHD
The company announced that the US FDA approved REZUROCK (belumosudil) on July 16, 2021, for chronic graft-versus-host disease (cGVHD) treatment in children above 12 years and adults after failure of two previous therapy lines. Commercial launch efforts are currently underway, emphasizing awareness regarding the differentiated clinical significance of REZUROCK and facilitating market access. Kadmon expects REZUROCK to be available in late August via a network of rare oncology/hematology specialty distributors and pharmacies.
On August 4, Kadmon announced that the National Comprehensive Cancer Network added REZUROCK to its Clinical Practice Guidelines in Oncology for Hematopoietic Cell Transplantation in Pre-Transplant Recipient Evaluation and Management of GVHD in the US.
CEO Harlan W. Waksal said, “The recent U.S. FDA approval of REZUROCK marked a transformative event for Kadmon and for patients living with cGVHD. REZUROCK represents a paradigm shift in the cGVHD treatment landscape by uniquely addressing both the immune and fibrotic components of the disease. We look forward to bringing this meaningful new therapy to patients in the U.S. by the end of this month.”
Kadmon to release belumosudil study in SSc results by end year
The company anticipates presenting preliminary data from its open-label Phase II belumosudil clinical study in patients with SSc by the end of this year. Equally, it will continue enrolment in the current placebo-controlled second phase clinical study in SSc (KD025-209).
Waksal said, “Our momentum continues as we advance our portfolio of product candidates. Initial data from our open-label, Phase 2 trial of belumosudil for the treatment of systemic sclerosis is anticipated by year-end 2021. The recent positive initial safety data presented at ASCO on KD033, our anti-PD-L1/IL-15 fusion protein, supports our confidence in the therapeutic potential of IL-15 for cancer. We look forward to sharing additional clinical data from this trial in the fourth quarter of 2021.”