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Kadmon Holdings (NASDAQ: KDMN) announced a proposed private offering of $150 million in convertible senior notes due 2027. The offering may be increased by an additional $30 million to cover over-allotments. The notes will be convertible into cash or common stock and will mature on February 15, 2027. Kadmon plans to use proceeds for the commercialization of belumosudil for chronic graft-versus-host disease, development of other clinical candidates, and general corporate purposes. The company will also engage in capped call transactions to manage potential dilution.
Kadmon Holdings, Inc. (KDMN) announced 12-month data from its pivotal ROCKstar trial of belumosudil for treating patients with chronic graft-versus-host disease (cGVHD) during the 62nd ASH Annual Meeting. The trial revealed Overall Response Rates (ORRs) of 73% for 200 mg QD and 77% for 200 mg BID, statistically significant with p<0.0001. Secondary endpoints showed a 58% failure-free survival rate and significant quality-of-life improvements. Kadmon's NDA for belumosudil has been accepted by the FDA, with a PDUFA date of May 30, 2021.
Kadmon Holdings (NASDAQ: KDMN) announced that the FDA has accepted its New Drug Application (NDA) for belumosudil (KD025), a treatment for chronic graft-versus-host disease (cGVHD). The FDA granted Priority Review with a PDUFA date set for May 30, 2021. The NDA is supported by positive data from the pivotal ROCKstar trial, which showed an overall response rate of up to 74%. The FDA previously designated belumosudil as a Breakthrough Therapy and granted it Orphan Drug Designation. The announcement indicates Kadmon's ongoing commitment to addressing unmet medical needs.
Kadmon Holdings (NASDAQ: KDMN) will host a virtual key opinion leader event on December 6, 2020, at the 62nd American Society of Hematology Annual Meeting. Corey Cutler, MD, will present updated 12-month data from the pivotal ROCKstar trial of belumosudil for chronic graft-versus-host disease (cGVHD). The live event aims to discuss the drug’s potential role in cGVHD treatment, pending FDA approval. The presentation will be accessible via Kadmon's investors page. Belumosudil shows promising response rates, achieving 73% and 74% in two arms of the trial.
Kadmon Holdings (NASDAQ: KDMN) announced that CEO Harlan W. Waksal will present at two upcoming virtual investor conferences. The Jefferies Virtual London Healthcare Conference is scheduled for November 18, 2020, at 12:35 p.m. ET, and the Evercore ISI 3rd Annual HealthCONx Virtual Conference will take place on December 3, 2020, at 8:00 a.m. ET. Live audio webcasts will be accessible on the Kadmon website, with replays available for 90 days. Kadmon focuses on developing therapies for unmet medical needs, particularly in immune and fibrotic diseases, and immuno-oncology.
Kadmon Holdings (NASDAQ:KDMN) announced its Q3 2020 financial results, highlighting the submission of the New Drug Application for belumosudil to the FDA, aimed at treating chronic GVHD. CEO Harlan W. Waksal noted the pivotal ROCKstar trial data will be presented in December 2020. The FDA also granted Orphan Designation for belumosudil in systemic sclerosis. Financially, the company reported a loss from operations of $28.0 million for Q3, up from $23.2 million in 2019, while liquidity improved to $150.5 million, reflecting recent capital raises.
Kadmon Holdings (NASDAQ: KDMN) announced that 12-month data from the pivotal ROCKstar trial for belumosudil in chronic graft-versus-host disease (cGVHD) will be presented at the 62nd ASH Annual Meeting from December 5-8, 2020. The presentation on December 6 by Dr. Corey Cutler will cover efficacy, safety data, and secondary endpoints. Previously, belumosudil met the primary endpoint and an NDA was submitted to the FDA. The study involved 66 patients, showing Overall Response Rates of 73% and 74%. Belumosudil has received Breakthrough Therapy and Orphan Drug Designation.
Kadmon Holdings (NYSE: KDMN) announced its voluntary transfer from the New York Stock Exchange to the Nasdaq Global Select Market, with trading expected to start on October 26, 2020. The company aims to leverage Nasdaq's infrastructure and expand its exposure within the biotechnology sector, particularly with an anticipated inclusion in the Nasdaq Biotechnology Index. Kadmon focuses on developing therapies for unmet medical needs.
Kadmon Holdings (NYSE: KDMN) announced the submission of a New Drug Application (NDA) for belumosudil (KD025) to the FDA aimed at treating chronic graft-versus-host disease (cGVHD). This submission is part of the FDA's Real-Time Oncology Review pilot program, designed to expedite the review process. The NDA is supported by data from the pivotal ROCKstar trial, which showed a promising overall response rate of 73% and 74% in treatment arms. Belumosudil has already received Breakthrough Therapy and Orphan Drug designations.
Kadmon Holdings (NYSE:KDMN) announced on September 8, 2020, that the FDA has granted Orphan Drug Designation to its drug belumosudil (KD025) for treating systemic sclerosis (SSc). SSc affects 75,000 to 100,000 people in the U.S. and has no effective treatments currently available. The drug's dual mechanism targets both immune and fibrotic components, showing potential in clinical studies. Kadmon is conducting a Phase 2 trial involving 60 patients and plans to submit a New Drug Application for chronic graft-versus-host disease (cGVHD) by Q4 2020.
