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

On September 22, 2025 Sartar therapeutics reported it 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 its SAR003 drug candidate (Press release, Sartar Therapeutics, SEP 22, 2025, View Source [SID1234656150]). This is a great milestone for its team and a significant regulatory protection for SAR003 program. Sartar has previously received ODDs for SAR003 for the treatment of gastrointestinal stromal tumours (GIST) by both EMA and FDA.

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Now it has the ODD protection for SAR003 for the treatment of all soft tissue sarcomas in the US.