Outlook Therapeutics Says FDA Issued Complete Response Letter to ONS-5010 BLA Resubmission

MT Newswires Live

01/01

Outlook Therapeutics (OTLK) said Wednesday the US Food and Drug Administration has issued a complete response letter to the ONS-5010 biologics license application resubmission.

The move indicates the regulator cannot approve the application in its present form for the treatment of wet age-related macular degeneration, the company said.

Outlook Therapeutics said it is exploring "all available pathways" for potential clearance in the US and it also plans to continue its efforts to expand into more markets in Europe and other regions.

Trading in shares of Outlook Therapeutics were halted.

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