No update from the FDA regarding Oncopeptides’ appeal

January 8, 2024

Oncopeptides has not yet received any notification from the US Food and Drug Administration (FDA) regarding the company’s appeal of the authority’s request to withdraw Pepaxto’s approval in the US. Oncopeptides has not received any time indication for when an announcement may come.

Oncopeptides previously communicated that the company expected a decision during the second half of 2023, based on advice from outside advisors as well as suggestions from US authorities that this is an accelerated process.

Oncopeptides’ current assessment is that a decision will be made in the near future. Should any change in that view or new information emerge, this will be communicated to the market immediately.