Outlook Therapeutics® Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial
Outlook Therapeutics, Inc. (OTLK)
Last outlook therapeutics, inc. earnings: 2/14 08:00 am
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Source: GlobeNewswire
Final efficacy data expected in January 2025Anticipate resubmission of BLA in calendar Q1 2025 ISELIN, N.J., Nov. 27, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced preliminary topline results of NORSE EIGHT, the second of two adequate and well controlled clinical trials evaluating ONS-5010 in wet AMD patients. Upon the completion of analysis of the final results of NORSE EIGHT, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) application for ONS-5010 in the first quarter of calendar 2025. In the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the U.S.
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News
- Outlook Therapeutics® Reports Financial Results for Fiscal Year 2024 and Provides Corporate UpdateGlobeNewswire
- Outlook Therapeutics® Streamlines OperationsGlobeNewswire
- Outlook Therapeutics® Announces NICE Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD [Yahoo! Finance]Yahoo! Finance
- Outlook Therapeutics® Announces NICE Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMDGlobeNewswire
- Outlook Therapeutics® Announces Executive Leadership Transition [Yahoo! Finance]Yahoo! Finance
OTLK
Earnings
- 8/14/24 - Beat
OTLK
Sec Filings
- 12/27/24 - Form 8-K
- 12/16/24 - Form 8-K
- 12/4/24 - Form 8-K
- OTLK's page on the SEC website