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Here is why SpringWorks Therapeutics jumped 20%

Here is why SpringWorks Therapeutics jumped 20%
Ruchi Gupta
May 27, 2022, 16:13 PM
  • Springworks releases data from the DeFi study on nirogacestat
  • DeFi study attained the primary objective of progression-free survival
  • More data from the DeFi study is expected in 2H 2022

SpringWorks Therapeutics Inc. (NASDAQ: SWTX) stock jumped 20% after the clinical-stage company focusing on life-changing treatment for cancer, and rare diseases announced encouraging results from its DeFi study. The trial was a placebo-controlled, double-blind third phase study assessing the safety, tolerability, and efficacy of the company's experimental oral gamma-secretase inhibitor, Nirogacestat, in the treatment of progressing desmoid tumors.

Springworks releases data on the DeFi study.

CEO Saqib Islam said:

The primary goal of the DeFi trial was improved progression-free survival (PFS), with nirogacestat showing a statistically meaningful improvement versus control, with a 71% reduction in the probability of disease progression. Furthermore, the trial achieved all critical secondary goals, with nirogacestat showing statistically meaningful improvements in patient-reported outcomes and objective response rate when compared to placebo.

Nirogacestat was better tolerated and had a good side effect profile. However, a more significant percentage of women of reproductive age experienced ovarian dysfunction-related symptoms. Other adverse occurrences were mostly in line with what had been reported initially.

More data from the DeFi study is expected in 2H 2022

 More data is planned to be shared at a medical conference, and SpringWorks expects to file a New Drug Application (NDA) to the Food and Drug Administration in 2H 2022. Islam concluded:

 The FDA has designated Nirogacestat as an Orphan Drug for desmoid tumors treatment, while the European Commission has granted the drug Orphan Drug Designation for soft tissue sarcoma treatment. the drug was also issued with Fast Track and Breakthrough Therapy Designations for  treatment of persistent, unresectable, refractory, or recurrent deep fibromatosis or desmoid tumors  patients