Outlook Therapeutics Inc.’s stock tumbled 71% in premarket trade Wednesday, after the company said the U.S. Food and Drug Administration has issued a Control...
Outlook Therapeutics Inc.’s stock OTLK, +10.16% tumbled 71% in premarket trade Wednesday, after the company said the U.S. Food and Drug Administration has issued a Control Response Letter for the company’s Biologics License Application for a treatment for wet age-related macular degeneration. The FDA issues a CRL when it’s unable to approve a drug in its current form, and is seeking further confirmatory clinical evidence.
The treatment called ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD, Iselin, N.J.-based Outlook said in a statement. The company is working to address the regulator’s issues.
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