Press Releases

Date Title
February 14, 2024
Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2024 and Provides Corporate Update
NORSE EIGHT underway with first subject dosed and additional clinical sites beginning enrollment Continue to expect planned resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024 Anticipate review decision from European regulators in the first half of CY2024 ISELIN,
January 31, 2024
Outlook Therapeutics® Doses First Subject in NORSE EIGHT
NORSE EIGHT clinical trial is being conducted under Special Protocol Assessment (SPA) from FDA to support expected resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024, if successful ISELIN, N.J. , Jan. 31, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc.
January 23, 2024
Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010
Obtained clarity from U.S. Food and Drug Administration (FDA) on next steps to advance ONS-5010 NORSE EIGHT expected to commence in the first quarter of CY2024, enabling potential resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024 Private placements to top tier
December 22, 2023
Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU
Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024 Company reaffirms potential for European approval for ONS-5010 with Marketing Authorization Application (MAA) decision date anticipated in the first half of 2024 Resubmission of the ONS-5010 Biologics
December 19, 2023
Outlook Therapeutics® Submits Special Protocol Assessment (SPA) to FDA for Non-Inferiority Study of ONS-5010
NORSE EIGHT study on track to commence in Q1 2024 Resubmission of ONS-5010 Biologics License Application (BLA) in the U.S. expected by the end of calendar year 2024 ISELIN, N.J. , Dec. 19, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to
December 6, 2023
Outlook Therapeutics® Announces Strategic Organizational Realignment
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
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
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