Stock Alert: Kadmon Shares Up 11% In Premarket On Pivotal Trial Data Of KD025

(RTTNews) - Shares of Kadmon Holdings Inc. (KDMN) are rising over 11% in pre-market today, after the company announced positive topline results from the primary analysis of ROCKstar (KD025-213), the pivotal trial evaluating belumosudil (KD025) in patients with chronic graft-versus-host disease (cGVHD) who have received at least two prior lines of systemic therapy.

Belumosudil (KD025) achieved clinically meaningful and statistically significant Overall Response Rates of 73% with 200 mg once daily and 74% with 200 mg twice daily. Responses were achieved across key patient subgroups and complete responses were observed in all organ systems.

The study had previously met the primary endpoint of Overall Response Rate or ORR at the interim analysis, which was conducted as scheduled as two months after completion of enrollment and was previously reported. Today's results from the primary analysis, which was conducted six months after completion of enrollment, show even greater efficacy of belumosudil (KD025) in cGVHD patients.

Further, Kadmon noted that it is submitting its New Drug Application or NDA to the U.S. FDA under the Real-Time Oncology Review or RTOR pilot program, an initiative of the FDA's Oncology Center of Excellence. Kadmon is on track to complete its NDA submission for belumosudil (KD025) in the fourth quarter of 2020.

The stock has been trading in the range of $1.63 - $5.50 for the past one year, and closed Wednesday's trade at $4.39, up 1 cent or 0.23%. KDMN is currently trading at $4.90, up 51 cents or 11.62% in the pre-market session.