Outlook Therapeutics® Doses First Subject in NORSE EIGHT
January 31, 2024 08:05 ET
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Outlook Therapeutics, Inc.
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...
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
January 23, 2024 08:00 ET
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Outlook Therapeutics, Inc.
Obtained clarity from U.S. Food and Drug Administration (FDA) on next steps to advance ONS-5010NORSE EIGHT expected to commence in the first quarter of CY2024, enabling potential resubmission of the...
Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU
December 22, 2023 08:05 ET
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Outlook Therapeutics, Inc.
Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024Company reaffirms potential for European approval for ONS-5010 with Marketing Authorization Application...
Outlook Therapeutics® Submits Special Protocol Assessment (SPA) to FDA for Non-Inferiority Study of ONS-5010
December 19, 2023 08:05 ET
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Outlook Therapeutics, Inc.
NORSE EIGHT study on track to commence in Q1 2024Resubmission 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 ...
Outlook Therapeutics® Announces Strategic Organizational Realignment
December 06, 2023 08:05 ET
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Outlook Therapeutics, Inc.
Realignment focused on supporting ONS-5010 U.S. and EU regulatory and commercial prioritiesContinued progress toward commencement of additional adequate and well-controlled study to support the...
Outlook Therapeutics® Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010
November 27, 2023 08:05 ET
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Outlook Therapeutics, Inc.
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...
Outlook Therapeutics® Adds Global Commercial Expertise with Appointment of Jedd Comiskey as Senior VP - Head of Europe
November 14, 2023 08:05 ET
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Outlook Therapeutics, Inc.
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...
Outlook Therapeutics® Provides Update on Type A Meetings with FDA
November 02, 2023 08:05 ET
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Outlook Therapeutics, Inc.
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...
Outlook Therapeutics® to Present at Guggenheim’s 5th Annual Inflammation, Neurology & Immunology (INI) Conference
November 01, 2023 08:05 ET
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Outlook Therapeutics, Inc.
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...
Outlook Therapeutics® Requests Type A Meeting With FDA
September 29, 2023 08:05 ET
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Outlook Therapeutics, Inc.
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...