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Kadmon Holdings' (KDMN) Rocking, Will The Rally Continue?

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Shares of Kadmon Holdings Inc. (KDMN) have gained an impressive 53% over the last 1 month.

Kadmon Holdings is a biopharmaceutical company whose therapeutic focus areas are inflammation & fibrosis, and immuno-oncology. The lead candidate is KD025, a small molecule ROCK2 inhibitor for chronic graft-versus-host disease (cGVHD).

The cGVHD is a common and often fatal complication following allogeneic hematopoietic cell transplantation, wherein the transplanted immune cells (graft) attack the patient's cells (host), leading to inflammation and fibrosis in multiple tissues.

Last month, the Company announced positive top-line results from the planned interim analysis of its ROCKstar trial.

ROCKstar is a pivotal, open-label clinical trial of KD025 in patients with chronic graft-versus-host disease (cGVHD) who have received at least two prior lines of systemic therapy.

The trial met the primary endpoint of Overall Response Rate (ORR) at the interim analysis, with KD025 showing statistically significant ORR of 64% at 200 mg once daily, and an ORR of 67% at 200 mg twice daily.

The primary analysis of the ROCKstar study, which will include updated safety data and efficacy data, including ORRs and secondary endpoints, such as duration of response, changes in corticosteroid dose and changes in quality of life, will occur in the first quarter of 2020.

A partnership with BioNova Pharmaceuticals Ltd was inked by Kadmon Holdings in November of this year to form a joint venture to exclusively develop and commercialize KD025 for the treatment of graft-versus-host disease (GVHD) in the People's Republic of China.

KD025 is also being evaluated as a treatment for systemic sclerosis, and a phase II trial in this indication is underway.

The Company, which ended September 30, 2019, with cash and cash equivalents of $66.1 million, completed an underwritten public offering of common stock with gross proceeds of $101.6 million in November.

KDMN traded in a range of $1.63 to $4.47 in the last 52 weeks. The stock closed Friday's (Nov.29, 2019) trading at $4.42, up 1.61%.

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