Date: June 20, 2022, 7:42 AM
Legal basis: Article 17 section 1 of the Market Abuse Regulation (MAR) – inside information.
In relation to the current report No. 10/2022 of April 20, 2022 on the submission of an application to the Food and Drug Administration (FDA) for the granting the Breakthrough Designation to Falkieri (Celon's esketamine DPI) in treatment-resistant bipolar depression therapy, the Management Board of Celon Pharma S.A. (the “Company”) informs that the aforementioned application has been rejected.
The Agency indicated that the reason for its refusal to grant the Breakthrough Designation to Falkieri (Celon’s esketamine DPI) in treatment-resistant bipolar depression therapy was failure to present data from a clinical trial for Falkieri where the subjects with treatment-resistant bipolar depression had a confirmed lack of response to a therapy using solely drugs approved by the FDA for treatment of bipolar depression.
As a result, the Agency cannot decisively make a final statement regarding the treatment-resistance status in accordance with the FDA's criteria.
In the light of the above, in the upcoming weeks the Company plans to consult the American regulatory authority on the possibility and date of refiling the application, whereas this time it would include the specific data indicated by the FDA.
The FDA’s rejection of the application at this stage does not impact the Company's plans for Falkieri in terms of development as well as clinical and business matters.
Currently, the Company may commence US-based clinical trials for Falkieri (Celon’s esketamine DPI), a drug developed for treatment-resistant bipolar depression as part of the Investigational New Drug (IND) application accepted by the FDA, of which the Company informed in its current report No. 11/2022 of May 2022.