SpringWorks Therapeutics, Inc. (SWTX) reported positive topline results from the DeFi trial, a double-blind, placebo-controlled phase 3 trial evaluating nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors. The trial met its primary endpoint of improving progression-free survival, showing a statistically significant improvement for nirogacestat over placebo, with a 71% reduction in the risk of disease progression. Also, the trial met all key secondary endpoints.
The company plans to submit a New Drug Application to the FDA in the second half of 2022.
Shares of SpringWorks Therapeutics were up 26% in pre-market trade on Tuesday.
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