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Immutep Limited (ASX:IMM)

ALERT: Price-sensitive ASX Announcement for IMM
Current share price for IMM : $0.048 0.009 (23.08%)+
Announcement
Release
15 Apr 2026 9:27AM
Price at Release
$0.039
Full Release
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Summary
Immutep Limited has announced that the FDA has granted Orphan Drug Designation (ODD) for eftilagimod alfa (efti) for the treatment of soft tissue sarcoma (STS), a rare cancer. This designation aims to encourage the development of therapies for rare diseases, offering benefits such as regulatory support, potential tax credits, fee exemptions, and market exclusivity upon approval. The decision is based on promising data from the Phase II EFTISARC-NEO trial, which evaluated efti with radiotherapy and KEYTRUDA® in patients with resectable STS, demonstrating significant tumor hyalinization and a favorable safety profile. Immutep is a biotechnology company focused on developing immunotherapies for cancer and autoimmune diseases, leveraging Lymphocyte Activation Gene-3 (LAG-3) related therapeutics.
Key Points
  • FDA granted Orphan Drug Designation for eftilagimod alfa in soft tissue sarcoma.
  • ODD aims to encourage therapies for rare diseases with benefits like regulatory support and market exclusivity.
  • EFTISARC-NEO trial showed significant results in tumor hyalinization with efti.
  • Immutep develops immunotherapies targeting cancer and autoimmune diseases.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.