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FDA Approves SpringWorks' Ogsiveo, First Treatment for Desmoid Tumors

Company's shares surge 18% following approval, with the drug set to cost $29,000 for a 30-day supply.

  • SpringWorks Therapeutics' drug, Ogsiveo, has been approved by the FDA as the first and only treatment for desmoid tumors, non-cancerous growths in connective tissue.
  • The approval led to an 18% increase in SpringWorks' share prices, despite remaining negative for the year.
  • The drug will be sold at a list price of $29,000 for a 30-day supply, higher than analysts' expectations.
  • CEO Saqib Islam described the approval as a 'watershed moment' for the desmoid tumor community and expects Ogsiveo to become the new standard of care.
  • SpringWorks plans to file a marketing application for Ogsiveo with the European Medicines Agency in the first half of 2024.
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