Outlook Therapeutics, Inc. (NASDAQ:OTLK) saw its stock climb roughly 50% following a decision from the U.S. Food and Drug Administration that came at the end of a Formal Dispute Resolution process with the agency's Office of New Drugs.
The FDA's Office of New Drugs concluded that substantial evidence of effectiveness exists for LYTENAVA (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration. Outlook Therapeutics said it expects to resubmit its Biologics License Application in June 2026.
The company initiated the dispute resolution process after conducting a Type A meeting with the Division of Ophthalmology and the Office of Specialty Medicine. That meeting concerned the agency's December 30, 2025 Complete Response Letter for the BLA for ONS-5010/LYTENAVA.
In its formal written response, the Office of New Drugs stated that results from the NORSE TWO clinical trial, when considered together with confirmatory evidence - including data from NORSE EIGHT, natural history information, and mechanistic and pharmacodynamic evidence - establish substantial evidence of effectiveness for LYTENAVA in treating neovascular age-related macular degeneration. The Office directed the Division and the Office of Specialty Medicine to collaborate with Outlook Therapeutics to reach agreement on final product labeling.
The FDA indicated the upcoming filing will be treated as a Class 1 resubmission, meaning the agency will assign a PDUFA date and expects to render a decision within 60 days of receiving the resubmission.
If the BLA for ONS-5010/LYTENAVA is approved, the product would represent the first FDA-approved ophthalmic formulation of bevacizumab that is supported by an FDA-approved manufacturing process, FDA-approved labeling, and a pharmacovigilance program.
Context and next steps
Outlook Therapeutics has signaled its intention to file the resubmission in June 2026. The Office of New Drugs' determination focuses on the totality of evidence submitted by the company, asking the relevant FDA offices to finalize labeling in coordination with Outlook.
Investors reacted promptly to the agency's decision, with the company's shares moving sharply higher on the news.
What remains to be resolved
The FDA's classification of the resubmission and the 60-day decision window apply from the agency's receipt of the resubmitted BLA. The outcome will depend on the content of that resubmission and the agency's subsequent review.