Shares of Outlook Therapeutics (OTLK) dropped sharply in after-hours trading after the U.S. Food and Drug Administration once again declined to approve the company's biologics license application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg). The FDA issued a complete response letter (CRL), stating that the application cannot be approved in its current form for the treatment of wet age-related macular degeneration (wet AMD).
In its letter, the FDA noted that while Outlook's resubmission included additional mechanistic and natural history data, this information did not change the agency's prior conclusion. The FDA acknowledged that one adequate and well-controlled study demonstrated efficacy but reiterated that confirmatory evidence of efficacy is required to support approval. Importantly, the agency did not specify what type of confirmatory evidence would be acceptable.
Outlook Therapeutics said it is exploring all available pathways for potential U.S. approval while continuing to expand internationally. The company highlighted that LYTENAVA (bevacizumab gamma) has already received Marketing Authorization from the European Commission and the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The drug became commercially available in Germany and the UK in June 2025, making it the first and only authorized ophthalmic formulation of bevacizumab for wet AMD in adults in those regions.
Outlook Therapeutics' stock closed at $1.58, down 15.51% on December 31. In after-hours trading, the stock fell even further to $0.58, a steep decline of $1.00 or 63.29%.
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