Outlook Therapeutics Inc.’s stock
OTLK,
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. “While the FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, the agency concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence,” said the statement. The stock is up 30% in the year to date, while the S&P 500 has gained 17%.
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