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Cantargia’s Nadunolimab Receives FDA Fast Track Designation

Story Highlights
  • Cantargia’s nadunolimab gains FDA Fast Track Designation for metastatic PDAC treatment.
  • The designation will expedite nadunolimab’s development and potential approval process.
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Cantargia’s Nadunolimab Receives FDA Fast Track Designation

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Cantargia AB ( (SE:CANTA) ) has shared an update.

Cantargia AB announced that its anti-IL1RAP antibody, nadunolimab, has received Fast Track Designation from the US FDA for treating metastatic pancreatic ductal adenocarcinoma (PDAC) with high IL1RAP expression. This designation, following promising clinical data, will facilitate the drug’s development with more frequent FDA interactions and potential for accelerated approval. The recognition underscores the high unmet medical need in metastatic PDAC and strengthens Cantargia’s efforts to provide new treatment options for patients with limited alternatives.

More about Cantargia AB

Cantargia AB is a biotechnology company focused on developing antibody-based treatments for life-threatening diseases. The company has established a platform based on the protein IL1RAP, which is involved in various cancer forms and inflammatory diseases. Cantargia’s oncology program includes the antibody nadunolimab, primarily studied in combination with chemotherapy for pancreatic cancer, non-small cell lung cancer, and triple-negative breast cancer. Additionally, Cantargia is developing CAN10 for autoimmune/inflammatory diseases.

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