Outlook Therapeutics Inc. (OTLK), a clinical-stage biopharmaceutical company, announced on Tuesday the completion of a federal dispute resolution (FDR) meeting with the U.S. Food and Drug Administration (FDA) regarding the regulatory pathway for ONS-5010/ LYTENAVA, a treatment for age related macular degeneration.
LYTENAVA (bevacizumab-vika) is an investigational, humanized monoclonal antibody developed to bind with the human vascular endothelial growth factor (VEGF) to prevent endothelial cell proliferation in neovascular age-related macular degeneration. The company had previously received a complete response letter (CRL) from the FDA in December, 2025, regarding the biologics license application (BLA) for LYTENAVA. In attending the Type A meeting with the Division of Ophthalmology and Office of Specialty Medicine, the company expects to align with the FDA in the required steps to approval.
A formal response from the FDA is anticipated for May, 2026.
OTLK is currently trading at $0.31, down 15.68%.
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