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Immutep Wins FDA Orphan Drug Status for Eftilagimod Alfa in Soft Tissue Sarcoma

9:36am on Wednesday 15th of April, 2026 AEST Biotechnology
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Immutep Wins FDA Orphan Drug Status for Eftilagimod Alfa in Soft Tissue Sarcoma

9:36am on Wednesday 15th of April, 2026 AEST
Key Points
  • FDA grants Orphan Drug Designation for eftilagimod alfa in rare soft tissue sarcoma
  • Phase II EFTISARC-NEO trial shows significant tumour response with efti combo therapy
  • Designation offers regulatory benefits including seven years market exclusivity
  • Immutep reassessing clinical strategy after halting Phase III TACTI-004 trial
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