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Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2022 and Provides Corporate Update
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) submitted to U.S. Food and Drug Administration (FDA); PDUFA date expected to be
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) submitted to U.S. Food and Drug Administration (FDA); PDUFA date expected to be announced in June 2022Advancing ONS-5010 toward potential marketing approval in early 2023U.S. pre-launch commercial planning continues to ramp upOperations supported by access to funding expected to be sufficient to launch LYTENAVA, if approved ISELIN, N.J., May 13, 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 recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2022. Recent Corporate Highlights Successfully submitted a BLA for ONS-5010, an investigational therapy which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg), for the treatment of wet age-related macular degeneration (wet AMD);Expanded commercial team with the appointment of Joel Prieve as Senior Vice President, Commercial Operations, in February 2022; andFurther expanded commercial team with appointment of Alicia Tozier as Senior Vice President, Marketing and Market Access, in March 2022. “This past quarter was marked by the achievement of the most important milestone to date for Outlook Therapeutics – the submission of our BLA for ONS-5010. In anticipation of potentially providing an on-label, FDA-approved alternative for wet AMD patients in the United States, we are ramping up our pre-commercial launch activities. To support these efforts, we have continued to add to the expertise of our commercial team to build momentum among partners, payors and the retina community. We are focused on positioning ourselves to unlock the full potential of ONS-5010,” commented C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics. ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Development Updates Outlook Therapeutics’ wet AMD clinical program for ONS-5010 consists of three completed clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE. With the successful completion of these clinical trials, Outlook Therapeutics submitted its BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in March 2022. If the BLA is approved, it is expec...