FDA issues Complete Response Letter to Outlook Therapeutics for ONS-5010 BLA; lacks efficacy evidence

Outlook Therapeutics, Inc.

CRL cites lack of substantial evidence of effectiveness; ONS-5010 did not meet primary endpoint in NORSE EIGHT trial.
FDA recommends confirmatory evidence; NORSE TWO met primary endpoint but is not sufficient alone.
No other deficiencies in BLA; company plans to meet with FDA to discuss possible path to approval.
ONS-5010/LYTENAVA already approved in EU and UK; commercial launch in Germany and UK began June 2025.

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