Kadmon Holding Inc. (NASDAQ:KDMN) has announced its Q3 financial and operational results and also offered a business update.
Kadmon submits New Drug Application for belumosudil
Harlan W. Waksal the company’s CEO and President, said that they submitted a New Drug Application for belumosudil. He said that this is a massive milestone for the company in its efforts to avail this therapy to Chronic GVHD patients. Waksal said that they are looking forward to presenting the 12-month durability, safety and efficacy data from the ongoing ROCKstar pivotal study of belumosudil next month at the Annual ASH meeting. Besides the safety and efficacy data, the presentation includes secondary endpoints of Failure Free Survival, duration of response, quality of life improvements and steroid dose reduction.
Besides cGVHD, the company also announced that the FDA had granted belumosudil Orphan Designation for systemic sclerosis treatment currently in second phase clinical trial. Waksal confirmed that the company is enrolling patients with locally advanced or metastatic solid tumours in phase 1 KD033 clinical study. KD033 is the company’s proprietary anti-PD-L1/IL-15 immuno-oncology fusion protein. The CEO confirmed that the company had finalized enrolment in the first cohort of the study, and second cohort enrolment is underway.
Kadmon preparing for the commercial launch of belumosudil
Kadmon is in discussion with the US FDA as it continues to review the NDA under the Real-Time Oncology Review pilot program. The program will explore an efficient review process to ensure effective and safe treatments are accessible to patients as early as possible. The company is readying itself for the commercial launch of belumosudil in anticipation of a possible FDA approval in 2021. The company will share an update on belumosudil’s pathway in Europe in 1H 2021.
Also, the company successfully completed the first 3-patient dose cohort in the dose-escalation first phase KD033 clinical trial. Equally, the ongoing Investigational New Drug Application KD045 enabling activities are ongoing. KD054 is the company’s next-generation ROCK inhibitor for treating fibrotic disease. Kadmon ended the quarter with cash and equivalents of $150.5 million.