Why SpringWorks Shares Are Soaring Today Premarket

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  • SpringWorks Therapeutics Inc SWTX has announced positive topline results from the DeFi Phase 3 trial evaluating nirogacestat in adult patients with progressing desmoid tumors.
  • Desmoid tumors are noncancerous growths occurring in the connective tissue, most often in the abdomen, arms, and legs.
  • The DeFi trial met its primary endpoint of improving progression-free survival, demonstrating a statistically significant improvement for nirogacestat over placebo, with a 71% reduction in the risk of disease progression. 
  • Also Read: AbbVie, SpringWorks Join Forces To Conduct Multiple Myeloma Combo Therapy Trial.
  • In addition, the trial met all key secondary endpoints, with nirogacestat demonstrating statistically significant improvements as compared to placebo in objective response rate and patient-reported outcomes. 
  • Nirogacestat was generally well tolerated with a manageable safety profile
  • SpringWorks plans to submit a marketing application to the FDA in 2H of 2022.
  • Nirogacestat has received Orphan Drug Designation from the FDA for desmoid tumors and from the European Commission to treat soft tissue sarcoma. 
  • The FDA also granted Fast Track and Breakthrough Therapy Designations for adult patients with progressive, unresectable, recurrent, refractory desmoid tumors or deep fibromatosis.
  • Price Action: SWTX shares are up 18.8% at $44.94 during the premarket session on the last check Tuesday.
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