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® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration [Yahoo! Finance]Yahoo! Finance
- Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug AdministrationGlobeNewswire
- Outlook Therapeutics, Inc. (NASDAQ: OTLK) had its price target lowered by analysts at Ascendiant Capital Markets from $33.00 to $24.00. They now have a "buy" rating on the stock.MarketBeat
- Outlook Therapeutics® Participates in the Virtual Investor “Top 5 for ‘25” On-Demand ConferenceGlobeNewswire
- Outlook Therapeutics, Inc. (NASDAQ: OTLK) had its "neutral" rating re-affirmed by analysts at Chardan Capital. They now have a $3.00 price target on the stock.MarketBeat
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- 2/14/25 - Miss
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- 3/12/25 - Form 4/A
- 3/10/25 - Form EFFECT
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