Outlook Therapeutics® Doses First Subject in NORSE EIGHT
Outlook Therapeutics, Inc. (OTLK)
Last outlook therapeutics, inc. earnings: 2/14 08:00 am
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Source: GlobeNewswire
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. (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 the first subject has been dosed in the NORSE EIGHT clinical trial evaluating ONS-5010 in neovascular age-related macular degeneration (wet AMD) patients. The NORSE EIGHT study is a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 treatment naive, wet AMD subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0 (randomization), Week 4, and Week 8 visits. The primary endpoi
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News
- Outlook Therapeutics® to Present at the Retina World Congress 2024GlobeNewswire
- Outlook Therapeutics® to Present at the Ophthalmology Innovation Summit (OIS) Retina Innovation Showcase [Yahoo! Finance]Yahoo! Finance
- Outlook Therapeutics® to Present at the Ophthalmology Innovation Summit (OIS) Retina Innovation ShowcaseGlobeNewswire
- Outlook Therapeutics® Announces Closing of Private Placement of $5.0 MillionGlobeNewswire
- Outlook Therapeutics: De-Risked Regulatory Tracks Are Lining Up For Possible ONS-5010 Approval [Seeking Alpha]Seeking Alpha
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- 2/14/24 - Beat
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- 5/1/24 - Form 8-K
- 4/26/24 - Form S-3
- 4/17/24 - Form SC
- OTLK's page on the SEC website