Outlook Therapeutics (NASDAQ:OTLK) stock fell sharply, tumbling 70% in pre-market trading Thursday following the U.S. Food and Drug Administration’s (FDA) rejection of its ONS-5010/LYTENAVA (bevacizumab-vikg) application, intended as a treatment for wet age-related macular degeneration (wet AMD).
The FDA issued a Complete Response Letter (CRL) for the company’s resubmitted Biologics License Application (BLA), citing a “lack of substantial evidence of effectiveness” and stating that it cannot approve the drug in its current form. The agency advised that Outlook submit additional confirmatory efficacy data after ONS-5010 failed to meet its primary endpoint in the NORSE EIGHT clinical trial.
This decision follows the agency’s acknowledgment that the earlier NORSE TWO trial had successfully achieved its primary effectiveness endpoint. The CRL did not identify any other 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 collaborate with the FDA to address the agency’s concerns while continuing its expansion 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 therapy became commercially available in Germany and the UK in June 2025.
Outlook Therapeutics aims to provide an FDA-approved alternative to compounded Avastin for wet AMD treatment in the U.S., offering a specifically formulated product for intravitreal use.
Outlook Therapeutics stock price
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