Outlook Therapeutics Receives FDA Agreement for Three Special Protocol Assessments for Additional Planned Clinical Trials of ONS-5010
Outlook Therapeutics, Inc. (OTLK)
Last outlook therapeutics, inc. earnings: 2/14 08:00 am
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Source: GlobeNewswire
ONS-5010, an investigational ophthalmic formulation of bevacizumab for retinal indications, is currently in two clinical trials to treat wet age-related macular degeneration (wet AMD – NORSE 1 and 2). SPAs for clinical trial protocols for NORSE 4 for branch retinal vein occlusion (“BRVO”) and NORSE 5 and NORSE 6 for diabetic macular edema (“DME”) indicate FDA agreement on overall protocol design (entry criteria, dose selection, endpoints and planned analyses). CRANBURY, N.J., Dec. 03, 2019 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a?late clinical-stage?biopharmaceutical company?working to develop the first FDA-approved ophthalmic formulation of bevacizumab?for use in retinal?indications, today announced that it has received agreement from the U.S. Food and Drug Administration (“FDA”) on three Special Protocol Assessments (“SPAs”) for three additional registration clinical trials for its ongoing Phase 3 program for ONS-5010, an investigational op
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- 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
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- 12/16/24 - Form 8-K
- 12/4/24 - Form 8-K
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