Outlook Therapeutics Submits Type A Meeting Request to FDA Following Complete Response Letter
Outlook Therapeutics, Inc. (OTLK)
Last outlook therapeutics, inc. earnings: 2/14 08:00 am
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Source: GlobeNewswire
ISELIN, N.J., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has submitted a Type A meeting request to the U.S. Food and Drug Administration (FDA) following receipt of a Complete Response Letter (CRL) dated December 30, 2025, regarding the Company’s Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD). The CRL identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence. Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA, including data from an adequate and well-controlled study and confirmatory evidence of effectiveness. Based on prior discussions with
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News
- Outlook Therapeutics Appoints Laura Cantrell as Vice President of Corporate Strategy and Business DevelopmentGlobeNewswire
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- Oncobiologics (NASDAQ:OTLK) was downgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=OTLK&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street ZeMarketBeat
- Third Time's The Charm: Outlook Therapeutics Lytenava Heads To FDA, Again [Seeking Alpha]Seeking Alpha
- Outlook Therapeutics Announces New Employment Inducement Grants [Yahoo! Finance]Yahoo! Finance
OTLK
Earnings
- 8/14/25 - Miss
OTLK
Sec Filings
- 2/11/26 - Form 8-K
- 2/5/26 - Form SCHEDULE
- 1/26/26 - Form ARS
- OTLK's page on the SEC website