SpringWorks Therapeutics Anticipates EMA Decision on Nirogacestat by Q2 2025
SpringWorks Therapeutics expects the European Medicines Agency (EMA) to provide its opinion on nirogacestat’s marketing authorization for treating desmoid tumors by the second quarter of 2025.
Company Overview
SpringWorks Therapeutics, Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA will likely assess its application for nirogacestat, an oral gamma secretase inhibitor for adults with desmoid tumors. This company specializes in addressing severe rare diseases and cancer. It already has the FDA-approved drug OGSIVEO® for desmoid tumors and GOMEKLI™ for neurofibromatosis type 1. SpringWorks is also actively developing a range of targeted therapies for different types of cancer. However, the press release includes forward-looking statements that highlight the risks and uncertainties typically associated with drug approval processes.
Potential Positives for Investors
- The anticipated CHMP opinion on nirogacestat could significantly improve SpringWorks’ market position in Europe.
- The FDA has already granted approval for nirogacestat, marking it as the first and only treatment for adults with desmoid tumors, attesting to the company’s commitment to rare diseases.
- SpringWorks’ expanding portfolio of innovative therapies suggests a strong pipeline, with potential for further growth in the biopharmaceutical sector.
Potential Negatives to Consider
- The press release points out regulatory risks; the EMA may require additional information or studies, which could delay the approval of nirogacestat.
- Uncertainties surrounding the timing and outcomes of regulatory approvals are highlighted, suggesting actual results may vary from expectations.
- The caution against over-reliance on forward-looking statements reflects a lack of certainty about the company’s future plans, which might affect investor confidence.
Frequently Asked Questions
What is the latest news about SpringWorks Therapeutics?
SpringWorks expects a CHMP opinion on nirogacestat’s marketing authorization application in Q2 2025.
What condition does nirogacestat aim to treat?
Nirogacestat is designed for adults with desmoid tumors.
What other products does SpringWorks offer?
SpringWorks manufactures OGSIVEO® for desmoid tumors and GOMEKLI™ for neurofibromatosis type 1.
What is the role of the European Medicines Agency (EMA) in this announcement?
The EMA’s CHMP will assess the marketing authorization application for nirogacestat.
How can I find more information about SpringWorks Therapeutics?
Visit www.springworkstx.com or follow @SpringWorksTx on social media for updates.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model may contain inaccuracies.
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Full Release
STAMFORD, Conn., April 27, 2025 (GLOBE NEWSWIRE) — SpringWorks Therapeutics,
SpringWorks Expects EMA Review for Nirogacestat by Q2 2025
SpringWorks Therapeutics Inc. (Nasdaq: SWTX), a biopharmaceutical company focused on severe rare diseases and cancer, announced its anticipation that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) will issue an opinion regarding the marketing authorization application (MAA) for nirogacestat. This oral gamma secretase inhibitor is intended for treating adults with desmoid tumors and is expected to receive attention in the second quarter of 2025.
Overview of SpringWorks Therapeutics
SpringWorks is committed to developing therapies aimed at improving the lives of patients suffering from severe rare diseases and cancers. The company is advancing OGSIVEO® (nirogacestat), recognized as the first FDA-approved treatment for adults with desmoid tumors. Additionally, they have introduced GOMEKLI™ (mirdametinib), the first FDA-approved medicine targeting both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN). The company also has a range of evolving targeted therapy candidates for patients with solid tumors and hematological cancers.
For more insights, visit www.springworkstx.com.
Forward-Looking Statements
This announcement contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. These statements pertain to SpringWorks’ business operations, financial conditions, and future plans, particularly the anticipated decision timelines from the CHMP regarding the nirogacestat marketing application. Words such as “look forward to,” “believe,” “expect,” and similar expressions indicate forward-looking statements. Actual outcomes may differ due to various risks and uncertainties, including regulatory submission timelines and approval processes.
Despite management’s belief in these projections, it is crucial for readers to understand that new uncertainties could emerge. Thus, undue reliance on these statements is discouraged.
For a comprehensive overview of potential risks, refer to the “Risk Factors” section in Item 1A of SpringWorks’ Annual report on Form 10-K for the fiscal year ending December 31, 2024, as well as subsequent filings.
Contact Information:
Media inquiries: [email protected]
Investor inquiries: [email protected]
The views expressed in this article represent those of the author and do not necessarily reflect those of Nasdaq, Inc.
