OTLKW - OTLKW STOCK NEWS

Outlook Therapeutics, Inc. (OTLK) announces realignment to support ONS-5010 U.S. and EU regulatory and commercial priorities. The company continues progress toward additional clinical trials for the ONS-5010 Biologics License Application in the U.S. and expects approval in Europe by the first half of 2024. The realignment includes the appointment of Joel Prieve as Senior Vice President of Licensing and M&A and Terry Dagnon as Senior Advisor. Additionally, Jedd Comiskey was added as Senior Vice President – Head of Europe to focus on potential commercial launch and partnership opportunities for ONS-5010 in the EU.

Outlook Therapeutics, Inc. (OTLK) plans to resubmit the ONS-5010 Biologics License Application (BLA) to the FDA by the end of 2024 pending final agreement on a clinical trial protocol and successful completion of the required additional clinical trial. The planned clinical trial is expected to be a 3-month non-inferiority study with a 60-day efficacy endpoint. The company received official minutes from the Type A meeting with the FDA regarding the Complete Response Letter (CRL) for the BLA, and is working to design an appropriate study to satisfy the FDA’s requirements. The company is encouraged by the productive discussions with the FDA and continues to believe in the potential of ONS-5010 to address the need for an approved ophthalmic bevacizumab for the treatment of wet AMD.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced the appointment of Jedd Comiskey as Senior VP – Head of Europe. Mr. Comiskey brings a successful track record in product launches and navigating the European pharmaceutical landscape. The company is preparing for the potential European launch of ONS-5010, with an expected Marketing Authorization Application (MAA) decision date in the first half of 2024. The appointment aims to strengthen the company's global launch strategy and potential European partnership for ONS-5010.

Outlook Therapeutics has completed Type A Meetings with the FDA to discuss the Complete Response Letter for ONS-5010, their ophthalmic formulation of bevacizumab for the treatment of retinal diseases. The FDA has requested an additional clinical trial for the approval of ONS-5010 for the treatment of wet AMD. Outlook Therapeutics has reached an agreement in principle with the FDA on a clinical trial design and aims to resubmit the BLA by the end of 2024, with approval expected in mid-2025.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced that its President and CEO, Russell Trenary, will participate in a fireside chat at Guggenheim’s 5th Annual Inflammation, Neurology & Immunology Conference on November 7th. The company is working towards FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases. The fireside chat will be accessible via a live audio webcast on the company's website.

Outlook Therapeutics submits Type A Meeting request to FDA to discuss Complete Response Letter (CRL) for ONS-5010, an ophthalmic formulation of bevacizumab. FDA acknowledged trial success but cited CMC issues, open observations, and lack of evidence. Company committed to addressing concerns.

Outlook Therapeutics CEO to participate in panel presentation at Cantor Fitzgerald Global Healthcare Conference on September 26th.

Outlook Therapeutics to present at H.C. Wainwright 25th Annual Global Investment Conference

FDA issues Complete Response Letter (CRL) for ONS-5010 BLA based on CMC and need for further confirmatory clinical evidence