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- SpringWorks Therapeutics Inc (NASDAQ: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.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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