A pivotal Phase 2 study evaluating Kadmon Holdings’ (NYSE:KDMN) lead candidate KD025 in patients with chronic graft-vs-host disease (cGvHD) who had received at least two prior lines of therapy met the primary endpoint at the interim analysis, two months after the completion of enrollment.
The objective response rate (ORR) was 64% in patients receiving once-daily 200 mg doses of KD025 and 67% in those receiving 200 mg twice daily.
No new safety signals were reported.
The primary analysis will happen next quarter.
The company plans to share the data with the FDA and submit it for presentation at a future medical conference. If all goes well, it expects to file a U.S. marketing application in 2020.
Shares up 17% after hours.
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