The Management Board of Celon Pharma S.A. (the “Company”) hereby informs that on April 20, 2022 an application was submitted to the Food and Drug Administration (FDA) concerning the commencement of a clinical trial for Falkieri (Celon’s esketamine DPI) as a therapy for treatment-resistant bipolar depression under the so-called Investigational New Drug (IND) Application procedure. Submission of the application is a formal stage towards the commencing the clinical development of Falkieri (Celon’s esketamine DPI) in the US.
Documents regarding the qualitative, pre-clinical and clinical development carried out to date was submitted alongside the application. The IND procedure can take up to several months.
Given the large size of the American market, the Management Board of the Company deems this fact to be pivotal for the development and global commercialization of the Falkieri project.