Outlook Therapeutics announces organizational realignment to support ONS-5010

Outlook Therapeutics announced a realignment of resources. Effective immediately, Joel Prieve, formerly the Senior Vice President of Commercial Operations, has been appointed to the role of Senior Vice President of Licensing and M&A. In this role, he will be responsible for developing and executing the Company’s strategy in the areas of licensing and partnerships, as well as evaluating and executing potential merger and acquisition opportunities. Additionally, Terry Dagnon, formerly COO, will assume the new role of Senior Advisor. Previously, Outlook Therapeutics announced the addition of Jedd Comiskey as Senior Vice President – Head of Europe to focus on potential commercial launch and commercial partnership opportunities for ONS-5010 in the EU, if approved. As previously reported, Outlook Therapeutics is working with the FDA to design an additional adequate and well-controlled clinical trial to support the planned ONS-5010 BLA resubmission. Based on the October Type A meeting and ongoing informal discussions with FDA, Outlook Therapeutics has submitted a protocol for a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naive patients with a primary efficacy endpoint at 2 months. Upon confirmation of the protocol details with the FDA, Outlook Therapeutics intends to submit a Special Protocol Assessment to memorialize the agreement with the FDA on the trial design and confirm that, if successful, this additional study, in combination with the successful completion of the ongoing work related to the CMC requests in the Complete Response Letter, would support approval of a resubmitted ONS-5010 BLA. Outlook Therapeutics continues to believe that the proposed clinical trial design as included in the Type A meeting request would allow for completion of the study and resubmission of the ONS-5010 BLA by the end of calendar year 2024. Outlook Therapeutics also submitted a Marketing Authorization Application in Europe, which was validated for review in December 2022. The formal review process of the MAA by the European Medicines Agency Committee for Medicinal Products for Human Use is underway with an estimated decision date expected in the first half of 2024.