<\/p>\n\n\n\n
Legal basis:<\/strong> Article 17 of the MAR Regulation \u2013 Inside Information, 5:13 p.m.<\/p>\n\n\n\n The Management Board of Celon Pharma S.A. (the \u201cCompany\u201d) hereby announces that on February 13, 2026, it completed its analysis of the written responses received from the U.S. Food and Drug Administration (\u201cFDA\u201d) to the questions submitted in the background package as part of a Type B Pre-IND meeting concerning the clinical development plan supporting the submission of an Investigational New Drug (IND) application and the proposed Phase III clinical trials of CPL\u201936 (Alofropodect) for the treatment of levodopa-induced dyskinesia in patients with Parkinson\u2019s disease (PD-LID).<\/p>\n\n\n\n According to the FDA\u2019s responses, the proposed pivotal Phase III trial concept, including, among other elements, the study design, duration, primary endpoint, and selected patient population, appears to be appropriate. The analysis of the FDA\u2019s responses confirms that the planned dosing regimen (20 mg once daily) appears justified from both clinical and pharmacological perspectives, while recommending the submission of additional supportive analyses as part of Phase III preparations. Furthermore, the FDA indicated that the proposed 12-month open-label extension (\u201cOLE\u201d) study is acceptable, subject to the inclusion of appropriate analytical assumptions.<\/p>\n\n\n\n The analysis indicates that, as development progresses, certain elements should be further strengthened. The FDA emphasized that the final requirements supporting a potential marketing application will depend on the totality of the data generated and highlighted the importance of demonstrating adequate long-term safety exposure in the target PD-LID population. The FDA also recommended strengthening selected methodological and statistical aspects to ensure the robustness of study conclusions and requested the submission of additional information relevant to Phase III readiness, including elements related to clinical pharmacology and safety assessment.<\/p>\n\n\n\n The Company believes that the FDA\u2019s feedback supports the continuation of activities aimed at implementing the Phase III program, while incorporating the FDA\u2019s recommended refinements into the study protocol and statistical analysis plan, as well as conducting the specified clinical pharmacology activities.<\/p>\n\n\n\n The Company intends to incorporate the FDA\u2019s recommendations into the final versions of the Phase III study protocols and to communicate all FDA recommendations and meeting outcomes to the partners with whom the Company is engaged in discussions regarding the commercialization of the project.<\/p>\n\n\n\n The Company will keep the market informed of subsequent significant milestones in the development of the clinical program, in particular the submission of documentation to the FDA and the Agency\u2019s decision regarding the initiation of Phase III clinical trials.<\/p>\n","protected":false},"excerpt":{"rendered":"