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Outlook Therapeutics' Biologics License Application Resubmission for ONS-5010 Accepted by FDA
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Outlook Therapeutics' Biologics License Application Resubmission for ONS-5010 Accepted by FDA
Nov 13, 2025 11:20 AM

01:51 PM EST, 11/13/2025 (MT Newswires) -- Outlook Therapeutics ( OTLK ) said Thursday that the US Food and Drug Administration accepted the resubmission of the Biologics License Application for ONS-5010, to be used for the treatment of wet age-related macular degeneration.

The FDA has set a Prescription Drug User Fee Act goal date of Dec. 31, Outlook Therapeutics ( OTLK ) said, adding that if approved, ONS-5010 will be branded as Lytenava (bevacizumab-vikg) for the treatment of wet AMD.

Shares of Outlook Therapeutics ( OTLK ) were up 18% in recent trading.

Price: 1.51, Change: +0.23, Percent Change: +17.97

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