Current report No. 11/2022 – Positive outcome of FDA’s assessment process of the IND application concerning the commencement of a clinical trial for Falkieri (Celon’s esketamine DPI)

Current report No. 11/2022
Date prepared: 2022-23-05, at 4:14 pm
Abbreviated name of the issuer: CELON PHARMA S.A.

In connection with current report No. 9/2022 of 20 April 2022 on Celon Pharma S.A. (the “Company”) submitting an application to the Food and Drug Administration (FDA), the Management Board of the Company informs that today it has received information from the American regulatory authority that the Company may commence clinical trials of Falkieri (Celon’s esketamine DPI), a drug developed as a therapy for treatment-resistant bipolar depression under the approved Investigational New Drug (IND) application in the US.

Submission of the application and receiving the above-mentioned consent to commence the clinical trial was, among others, the result of preparation and submission of a qualitative portfolio including, among others, outcomes of manufactured and released batches of Falkieri, (Celon’s esketamine DPI), which meet the FDA’s quality criteria.

More information about the progress in regard of this project in the US will be communicated in subsequent announcements.