Immutep secures FDA Orphan Drug Designation for eftilagimod alfa in soft tissue sarcoma, a rare cancer affecting fewer than 200,000 people in the US.

Immutep secures FDA Orphan Drug Designation for eftilagimod alfa in soft tissue sarcoma, a rare cancer affecting fewer than 200,000 people in the US. The designation provides regulatory support, potential tax credits, fee exemptions, and seven years of market exclusivity upon approval. This decision is backed by promising Phase II EFTISARC-NEO trial data showing a median tumor hyalinization of 51.5%, significantly exceeding the pre-specified target of 35%. The positive regulatory news comes as the company discontinues its TACTI-004 Phase III trial due to futility, which is expected to extend cash runway beyond Q2 2027. Immutep continues advancing its LAG-3 pipeline while managing operational losses of A$61.4 million in 2025.