OTLK

Latest SEC Filings & News for OTLK

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FDA accepts resubmitted BLA for Outlook's LYTENAVA with July 29, 2026 decision date

Outlook Therapeutics announced FDA acceptance of its resubmitted Biologics License Application for ONS-5010/LYTENAVA (bevacizumab-vikg) as a treatment for wet AMD, with a PDUFA target action date of July 29, 2026. If approved, LYTENAVA would be the first FDA-approved ophthalmic f

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Outlook Therapeutics resubmits bevacizumab-vikg BLA to FDA for nAMD treatment

Outlook Therapeutics resubmitted its Biologics License Application for ONS-5010/LYTENAVA to the FDA after successfully appealing a Complete Response Letter, with a Class 1 review designation and expected decision within 60 days. If approved, the product would be the first FDA-app

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FDA grants appeal for Outlook's LYTENAVA bevacizumab; BLA resubmission planned June 2026

The FDA's Office of New Drugs determined that substantial evidence supports the effectiveness of ONS-5010/LYTENAVA for neovascular age-related macular degeneration following the formal dispute resolution process. Outlook plans to resubmit the biologics license application in June

View filing at SEC.gov →
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