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Investing.com -- Outlook Therapeutics (NASDAQ:OTLK) stock plummeted 70% Thursday morning after the U.S. Food and Drug Administration (FDA) rejected its application for ONS-5010/LYTENAVA (bevacizumab-vikg), a treatment for wet age-related macular degeneration (wet AMD).
The FDA issued a Complete Response Letter (CRL) to the company’s resubmitted Biologics License Application (BLA), stating it cannot approve the application in its current form due to "lack of substantial evidence of effectiveness." The agency recommended that Outlook submit confirmatory efficacy evidence to support the application after the drug failed to meet its primary endpoint in the NORSE EIGHT clinical trial.
The setback comes despite the FDA acknowledging that the company’s earlier NORSE TWO trial had met its primary effectiveness endpoint. The CRL identified no other outstanding deficiencies in the BLA submission.
"While we are very disappointed with this outcome, we intend to meet with the FDA to receive additional clarity on their requirements to potentially approve the first on-label bevacizumab product specifically formulated, manufactured, and packaged for intravitreal use in the United States," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics.
The company plans to work with the FDA to address the agency’s concerns while continuing its expansion efforts in Europe, where LYTENAVA has already received marketing authorization from both the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency. The drug became commercially available in Germany and the UK in June 2025.
Outlook Therapeutics is seeking to provide an FDA-approved alternative to compounded Avastin for wet AMD treatment in the United States.
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