Immutep's efti receives FDA Orphan Drug Designation for STS

Immutep announced that the FDA has granted Orphan Drug Designation (ODD) for its drug eftilagimod alfa ("efti") for the treatment of Soft Tissue Sarcoma (STS). This designation provides significant benefits, including regulatory support, potential tax credits, fee exemptions, and seven years of market exclusivity upon approval. The ODD is supported by encouraging data from the Phase II EFTISARC-NEO trial, which demonstrated a median tumor hyalinization/fibrosis of 51.5%, surpassing the pre-specified target of 35%. The company views this as a potential direct path to a late-stage study in the neoadjuvant setting for STS.