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Outlook Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2022 and Reiterates Key Anticipated Near-Term Milestones
Planned re-submission of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) on track
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Planned re-submission of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) on track ISELIN, N.J., Aug. 10, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced its financial results for its fiscal third quarter ended June 30, 2022, provided recent corporate highlights, and reiterated its anticipated near-term milestones. Recent Corporate Highlights Announced the full cash pre-payment of its $12.3 million unsecured convertible promissory note dated November 4, 2020, as amended November 16, 2021; andConfirmed plans to re-submit ONS-5010 BLA by September 2022. “We have received invaluable line-of-sight related to the additional requirements for a successful ONS-5010 BLA re-submission. Following productive feedback from the FDA, we established a clear path forward and are highly focused on executing the necessary items to meet our planned re-submission by September of this year. Additionally, we continue to position ourselves operationally and financially for the potential FDA approval and subsequent launch of ONS-5010. Our confidence in its potential remains unwavering. If approved, ONS-5010 would be the first FDA-approved ophthalmic formulation of bevacizumab, avoiding the public health risk to patients of off-label treatment of bevacizumab. We believe there is value in achieving the strict safety and efficacy requirements associated with an FDA approval, and we expect to meet these standards,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. Upcoming Anticipated Milestones Complete re-submission of BLA for ONS-5010 for the treatment of wet age-related macular degeneration (wet AMD);Receive Prescription Drug User Fee Act (PDUFA) target action date from FDA;Continue progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in 2023; andSubmission of Marketing Authorisation Application (MAA) in EU for ONS-5010. ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Development Updates Outlook Therapeutics’ wet AMD clinical program for ONS-5010 consists of three completed clinical trials, NORSE ONE,...