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Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2024 and Provides Corporate Update
Received European Union (EU) and United Kingdom (UK) Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMDNORSE EIGHT current
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Received European Union (EU) and United Kingdom (UK) Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMDNORSE EIGHT current enrollment pace supports topline readout target of Q4 CY2024Resubmission of the ONS-5010 Biologics License Application (BLA) on track for Q1 CY2025Quarterly update conference call and webcast today, Wednesday, August 14th at 8:30 AM ET ISELIN, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that has achieved regulatory approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced financial results for the third quarter of fiscal year 2024 and provided a corporate update. As previously announced, Outlook Therapeutics will host its quarterly conference call and live audio webcast, today, Wednesday, August 14, 2024, at 8:30 AM ET (details below). “This quarter we achieved two major milestones with receipt of Marketing Authorization in both the European Union and the United Kingdom. Additionally, we made significant progress with our primary focus, which remains the successful completion of enrollment in our ongoing NORSE EIGHT clinical trial. Based on our enrollment progress, we expect to report those results in the fourth calendar quarter of 2024 with the anticipated resubmission of our BLA in the first calendar quarter of 2025,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. “Meanwhile, we continue commercial preparations to launch the first, and only, ophthalmic approved bevacizumab for the treatment of wet AMD in the EU and UK, either directly or with a partner, anticipated in the first half of calendar year 2025.” Upcoming Anticipated Milestones Full enrollment of NORSE EIGHT clinical trial in the US expected in Q3 CY2024;Topline readout of NORSE EIGHT clinical trial planned in Q4 CY2024;Resubmission of the ONS-5010 BLA targeted for Q1 CY2025;Initial commercial launches in Europe planned to commence in first half of CY2025; andPotential for US FDA approval of ONS-5010 in second half of CY2025. ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Clinical and Regulatory Update As previously announced, following Type A meetings with the US Food and Drug Administ...