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Outlook Therapeutics Requests Meeting With US FDA Regarding Complete Response Letter for ONS-5010
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Outlook Therapeutics Requests Meeting With US FDA Regarding Complete Response Letter for ONS-5010
Sep 2, 2025 10:51 AM

01:38 PM EDT, 09/02/2025 (MT Newswires) -- Outlook Therapeutics ( OTLK ) said Tuesday it submitted a Type A meeting request to the US Food and Drug Administration to discuss a complete response letter for a biologics license application resubmission for ONS-5010, an investigational treatment for wet macular degeneration.

The company said it has requested a meeting as it seeks to clarify details regarding confirmatory evidence required by the agency.

Shares of the company were up over 5% in recent Tuesday trading.

Price: 0.90, Change: +0.05, Percent Change: +5.29

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