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Outlook Therapeutics
OTLK.US
Outlook Therapeutics, Inc., operates as a clinical-stage biopharmaceutical company, focuses on developing and commercializing monoclonal antibodies for ophthalmic indications. Its lead product candidate is ONS-5010, an ophthalmic bevacizumab product formulation of bevacizumab product candidate that is in Phase-III clinical trial for the treatment of wet age-related macular degeneration and other retina diseases. Outlook Therapeutics, Inc. has collaboration agreements with Cencora.
1.945 T
OTLK.USMarket value -Rank by Market Cap -/-

Financial Score

05/12/2025 Update
D
BiotechnologyIndustry
Industry Ranking278/394
Industry medianC
Industry averageD
Score Analysis
Peer Comparison
  • Criteria
    Rating
  • Profit ScoreB
    • ROE71.88%A
    • Profit Margin-2885.82%E
    • Gross Margin64.70%A
  • Growth ScoreC
    • Revenue YoY0.00%C
    • Net Profit YoY53.81%B
    • Total Assets YoY-52.45%E
    • Net Assets YoY55.55%A
  • Cash ScoreD
    • Cash Flow Margin-3.47%D
    • OCF YoY0.00%C
  • Operating ScoreE
    • Turnover0.04E
  • Debt ScoreE
    • Gearing Ratio266.09%E

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Institutional View & Shareholder

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    News
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    Outlook Therapeutics to Present at the Piper Sandler 37th Annual Healthcare Conference

    Live webcast fireside chat on Tuesday, December 2nd at 10:00 AM ET Live webcast fireside chat on Tuesday, December 2nd at 10:00 AM ET ...

    GlobeNewswire·
    US
    OTLK
    -4.13%
    GlobeNewswire·
    US
    OTLK
    -4.13%

    H.C. Wainwright Sticks to Its Hold Rating for Outlook Therapeutics (OTLK)

    H.C. Wainwright's Douglas Tsao maintains a Hold rating on Outlook Therapeutics with a $1.00 price target. Tsao, a 5-star analyst with a 22% average return, focuses on healthcare stocks. The consensus rating for Outlook Therapeutics is Hold, with an average price target of $4.00.

    Tip Ranks·
    US
    OTLK
    -4.13%
    Tip Ranks·
    US
    OTLK
    -4.13%

    FDA Sets December 31 PDUFA Date for Outlook Therapeutics’ ONS-5010 BLA Review

    Outlook Therapeutics announced that the FDA has received its resubmitted Biologics License Application for ONS-5010 (bevacizumab-vikg). The FDA classified it as a Class 1 review with a two-month review period and set a PDUFA goal date of December 31, 2025, for the decision.

    Reuters·
    US
    OTLK
    -4.13%
    Reuters·
    US
    OTLK
    -4.13%

    Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010 | OTLK Stock News

    Outlook Therapeutics, Inc. has re-submitted its Biologics License Application (BLA) for ONS-5010 to the FDA, following a Type A meeting in September 2025. ONS-5010 is an investigational formulation of bevacizumab aimed at treating wet age-related macular degeneration (wet AMD). The company is optimistic that this resubmission will address previous concerns raised in an earlier Complete Response Letter. If approved, ONS-5010 will be marketed as LYTENAVA™ in the U.S. and has already received marketing authorization in Europe and the UK.

    StockTitan·
    US
    OTLK
    -4.13%
    StockTitan·
    US
    OTLK
    -4.13%

    Biotechnology Sector: Between Fed Easing and Regulatory Risks

    The biotechnology sector experienced moderate growth in August 2025, driven by favorable U.S. inflation data and expectations of Federal Reserve rate cuts. However, political uncertainties and regulatory challenges, such as the FDA's rejection of Outlook Therapeutics' drug, created volatility. Despite this, M&A activity remained strong among major players. Looking ahead, September may bring challenges, but key FDA decisions and clinical trial results could provide catalysts for stock movements, particularly for drugs like Scholar Rock's apitegromab and MoonLake Immunotherapeutics' sonelokimab.

    GuruFocus·
    US
    SRRK
    -0.44%
    US
    OTLK
    -4.13%
    GuruFocus·
    US
    SRRK
    -0.44%
    US
    OTLK
    -4.13%
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