Kadmon's REZUROCK Scores Quick FDA Win For Chronic Graft-Versus-Host Disease

Friday afternoon, the FDA approved Kadmon Holdings Inc's KDMN REZUROCK to treat chronic graft-versus-host disease (cGVHD), a serious complication of transplant procedures.
Formerly known as belumodsil, the drug is a first-in-class ROCK2 inhibitor and now Kadmon's first approved drug.
cGVHD occurs when donor cells mount an immune response against a patient's tissues and organs, leading to inflammation and fibrosis in multiple tissues.
The FDA based its REZUROCK approval on data from an open-label trial called ROCKstar that enrolled 65 patients who had previously tried between two and five different treatments.
Of the 65 patients in the study given 200mg of Rezurock twice daily, just under half of them had four or more organs affected by the disease.
6% of patients achieved a complete response and 69% partial response, Kadmon said.
62% of responders didn't require new systemic therapy for at least 12 months. The median time to first response was 1.8 months.
The FDA approval came six weeks ahead of the agency's decision deadline of 30 August.
REZUROCK won't be available until the end of August, Kadmon said.
Price Action: KDMN shares are up 0.23% at $4.29 during the premarket session on the last check Monday.
Related content: Benzinga's Full FDA Calendar.