Press Releases

Date	Title
November 27, 2023	Outlook Therapeutics® Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010 Resubmission of the ONS-5010 BLA on track for the end of calendar year 2024, pending final agreement on a clinical trial protocol with the FDA and successful completion of the required additional clinical trial Planned clinical trial expected to be a 3-month non-inferiority study with 60 day
November 14, 2023	Outlook Therapeutics® Adds Global Commercial Expertise with Appointment of Jedd Comiskey as Senior VP - Head of Europe ISELIN, N.J. , Nov. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced the appointment of Jedd Comiskey as
November 2, 2023	Outlook Therapeutics® Provides Update on Type A Meetings with FDA ISELIN, N.J. , Nov. 02, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that it has completed the requested Type
November 1, 2023	Outlook Therapeutics® to Present at Guggenheim’s 5th Annual Inflammation, Neurology & Immunology (INI) Conference Live audio webcast fireside chat on Tuesday, November 7th at 1:50 PM ET ISELIN, N.J. , Nov. 01, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of
September 29, 2023	Outlook Therapeutics® Requests Type A Meeting With FDA ISELIN, N.J. , Sept. 29, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that a Type A Meeting request has been
September 21, 2023	Outlook Therapeutics® to Present at the 2023 Cantor Fitzgerald Global Healthcare Conference Live video webcast panel presentation on Tuesday, September 26th at 1:35 PM ET ISELIN, N.J. , Sept. 21, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the
September 5, 2023	Outlook Therapeutics® to Present at the H.C. Wainwright 25th Annual Global Investment Conference Live video webcast presentation on Wednesday, September 13th at 9:30 AM ET ISELIN, N.J. , Sept. 05, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment
August 30, 2023	Outlook Therapeutics® Provides Regulatory Update on FDA Review of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD FDA issues Complete Response Letter (CRL) for ONS-5010 BLA based on CMC and need for further confirmatory clinical evidence Outlook Therapeutics working with FDA to address the Agency’s issues Company to host conference call and webcast, today, August 30 at 8:30 AM ET ISELIN, N.J. , Aug.
August 14, 2023	Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2023 and Reiterates Key Anticipated Near-Term Milestones Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) ISELIN, N.J. , Aug. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc.
August 1, 2023	Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2023 Live webcast fireside chat on Monday, August 7th at 1:00 PM ET ISELIN, N.J. , Aug. 01, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of wet AMD,