OTLKW News and Press, Outlook Therapeutics Inc. Series A Warrant From 03/18/24

ISELIN, N.J., March 18, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed...

ISELIN, N.J., March 12, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”), 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 1...

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 o...

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, I...

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 t...

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...

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 c...

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...

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 ...

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...