Kadmon Holdings (KDMN) - What's The Buzz?

(RTTNews) - Shares of Kadmon Holdings, Inc. (KDMN) are up over 11 percent in pre-market trading today, following the receipt of final minutes from the pre-NDA meeting related to KD025, which is being developed for the treatment of chronic graft-versus-host disease (cGVHD).

KD025 is under a pivotal phase II trial in chronic graft-versus-host disease, dubbed ROCKstar. As per the interim outcomes of the study, KD025 has been well-tolerated and has already demonstrated high response rates in patients with severe and complex cGVHD after a median of five months of follow-up.

Based on the feedback from the FDA, the Company believes the proposed data package will be sufficient to support the NDA submission of KD025 for the treatment of patients with cGVHD.

As previously announced, the topline results from the primary analysis of the ROCKstar trial are expected in the second quarter of 2020.

Kadmon ended the year 2019 with cash and cash equivalents of $139.6 million.

KDMN has traded in a range of $1.63 to $5.50 in the last 1 year. In pre-market trading on Tuesday, the stock is up 11.28% at $4.68.