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Full enrollment of 195 subjects in NORSE THREE achieved in less than one month, significantly ahead of schedule All planned clinical trials for ONS-5010/LYTENAVA ™ BLA for wet AMD now fully enrolled or comple...
MONMOUTH JUNCTION, N.J., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinalȂ...
First subjects have been enrolled in supplemental open-label safety study S tudy being conducted t o ensure the requisite number of patient exposures to ONS-5010 to support new BLA filing to the FDA in 2021 ONS-5010 ...
MONMOUTH JUNCTION, N.J., Oct. 07, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinalȂ...
MONMOUTH JUNCTION, N.J., Sept. 30, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) is a late clinical-stage biopharmaceutical company developing the first FDA-approved ophthalmic formulation of bevacizumab-vikg (LYTENAVA™) for use in retinal indications (known ...
MONMOUTH JUNCTION, N.J., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal ...
ONS-5010, an investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD, demonstrated safety and efficacy profile consistent with previously published ophthalmic bevacizumab research NORSE 1 results support trial design and inclusion criteria for fully enr...
Successfully completed NORSE 2 enrollment in July 2020 NORSE 1 topline results to be reported in August 2020 MONMOUTH JUNCTION, N.J., Aug. 14, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company worki...
MONMOUTH JUNCTION, N.J., July 17, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications,...
Pivotal NORSE 2 safety and efficacy data expected to be reported in the third calendar quarter of 2021 ONS-5010 / LYTENAVA ™ (bevacizumab-vikg) has the potential to be the first FDA-approved ophthalmic formulation of bevacizumab for use in multiple retinal indicatio...
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UK MHRA marketing authorization follows recent European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) in the EU for the treatment of wet AMD Initial commercial launches of LYTENAVA™ (bevacizumab gamma) in the EU and UK anticipated in calendar Q1 2025...
Live video webcast on Tuesday, June 18 th at 12:00 PM ET ISELIN, N.J., June 11, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the commercialization and development of ONS-5010/LYTENAVA™ (bevacizumab-vikg; be...
LYTENAVA™ (bevacizumab gamma) becomes first ophthalmic formulation of bevacizumab to receive European Commission Marketing Authorization for the treatment of wet AMD European Commission decision applies automatically to all 27 EU Member States and, within 30 days, also to Iceland, ...