- SpringWorks Therapeutics (SWTX, Financial) anticipates CHMP opinion for nirogacestat in Q2 2025.
- Nirogacestat is an oral gamma secretase inhibitor aiming to treat desmoid tumors.
- Approval would mark a significant regulatory milestone for SpringWorks in the EU market.
SpringWorks Therapeutics, Inc. (SWTX), a leading biopharmaceutical company, has announced the expected timeline for the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to deliver its opinion on the marketing authorization application for nirogacestat. This opinion is anticipated in the second quarter of 2025.
Nirogacestat is an oral gamma secretase inhibitor developed by SpringWorks Therapeutics for adults with desmoid tumors, a rare and debilitating type of tumor. If approved, nirogacestat would become a significant treatment option for patients within the European Union, providing a targeted therapeutic to manage and potentially mitigate this condition.
SpringWorks Therapeutics continues to progress in its mission to address severe rare diseases and cancer, leveraging its innovative pipeline of treatments. The company is presently awaiting a pivotal regulatory milestone decision that could expand its therapeutic offerings to the European market.
For additional updates and developments, please visit SpringWorks Therapeutics' official site or follow their social media channels for the latest news.
