Press release

Oncopeptides receives decision from the U.S. Food and Drug Administration confirming withdrawal of Pepaxto from the U.S. market

February 23, 2024

Stockholm – February 23, 2024 – Oncopeptides AB (publ), a biotech company focused on difficult-to-treat cancers, today announces that the U.S. Food and Drug Administration (FDA) has made a decision regarding the withdrawal of Pepaxto, which Oncopeptides had appealed.

In their decision, the FDA concludes that they have determined that the grounds for withdrawing the approval have been met. The full decision is, or will momentarily be, available in the public docket created by the FDA through the following link. Oncopeptides will now thoroughly assess the decision.

Oncopeptides’ focus remains on commercialization in Europe where the company has a full marketing authorization.