Outlook Therapeutics Inc - OTLKW STOCK NEWS

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

Outlook Therapeutics announces recent corporate highlights and financial results. The Prescription Drug User Fee Act (PDUFA) goal date for ONS-5010 is August 29, 2023. ONS-5010 is an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). Outlook Therapeutics is focused on pre-launch activities and positioning itself as an innovative leader in the anti-VEGF space. The use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50% of all wet AMD injections in the United States each year. ONS-5010 has been developed to address concerns related to safety and potency issues associated with using off-label, repackaged bevacizumab. Outlook Therapeutics has upcoming milestones including the completion of the NORSE SEVEN clinical trial in 2024 and the MAA decision date from the EMA’s CHMP in the EU expected in the first half of 2024.