Sartar received Orphan Drug Designation for soft tissue sarcomas from the FDA

22.9.2025 News

As published last week, we are very proud to announce that Sartar was recently granted an new orphan drug designation (ODD) by the U.S. Food & Drug Administration (FDA) for the treatment of soft tissue sarcomas using our SAR003 drug candidate. This is a great milestone for our team and a significant regulatory protection for SAR003 program. We have already previously received ODDs for SAR003 for the treatment of gastrointestinal stromal tumours (GIST) by both EMA and FDA.

Now we have the ODD protection for SAR003 for the treatment of all soft tissue sarcomas in the US.