OTLKW - Outlook Therapeutics® Announces Strategic Organizational Realignment | Benzinga
- Realignment focused on supporting ONS-5010 U.S. and EU regulatory and commercial priorities
- Continued progress toward commencement of additional adequate and well-controlled study to support the ONS-5010 Biologics License Application (BLA) in the U.S.
- European regulatory efforts and commercial strategy development continue to advance toward expected approval of ONS-5010 in Europe in the first half of 2024
ISELIN, N.J., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve U.S. Food and Drug Administration (FDA) approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today 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 Chief Operations Officer, 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 naïve 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 (SPA) 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 ...