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BRUSSELS - The European Commission has granted marketing authorization for OGSIVEO (nirogacestat), an oral gamma secretase inhibitor, for the treatment of adults with progressing desmoid tumors requiring systemic treatment, according to a statement from SpringWorks Therapeutics (SWTX), a healthcare company of Merck KGaA. According to InvestingPro data, SWTX shares have surged 30% year-to-date, currently trading at $46.99.
OGSIVEO becomes the first and only therapy approved in the European Union specifically for desmoid tumors, which are rare, locally aggressive tumors that form in the connective tissues of the body. Approximately 1,300 to 2,300 new cases are diagnosed annually in the EU. InvestingPro data shows SpringWorks has demonstrated remarkable revenue growth of over 730% in the last twelve months, with a strong current ratio of 4.33 indicating solid financial stability. Get detailed analysis and 12+ additional ProTips with an InvestingPro subscription.
The approval is based on results from the Phase 3 DeFi trial involving 142 adult patients with progressing desmoid tumors. The study met its primary endpoint with OGSIVEO demonstrating a 71% reduction in the risk of disease progression compared to placebo. The confirmed objective response rate was 41% with OGSIVEO versus 8% with placebo.
"Desmoid tumors can have a profound impact on people’s lives and are difficult to manage due to their invasive nature and high rates of recurrence," said Bernd Kasper, Professor at the University of Heidelberg and principal investigator of the DeFi trial.
The most common adverse reactions reported in patients receiving OGSIVEO included diarrhea (85%), rash (65%), ovarian toxicity in women of childbearing potential (60%), nausea (59%), and fatigue (50%).
This marks the second recent European Commission approval for Merck KGaA in the rare tumor space, following last month’s authorization of a therapy for patients with NF1-PN.
Desmoid tumors primarily affect patients between the ages of 20 and 44 years, with a two-to-three times higher prevalence in females. These tumors can cause severe pain, limited function, loss of mobility, and fatigue, significantly impacting quality of life. For comprehensive insights into SpringWorks Therapeutics’ financial health and growth prospects, access the detailed Pro Research Report available exclusively on InvestingPro, covering what really matters for informed investment decisions.
In other recent news, SpringWorks Therapeutics has received conditional marketing authorization from the European Commission for its drug EZMEKLY (mirdametinib) to treat symptomatic, inoperable plexiform neurofibromas in patients with neurofibromatosis type 1 (NF1). This approval marks the first therapy available in the European Union for both adults and children with NF1-PN. Additionally, Merck KGaA has completed its acquisition of SpringWorks Therapeutics, making the company a wholly owned subsidiary. The acquisition was finalized at $47 per share as outlined in a merger agreement dated April 27, 2025. Moreover, the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nirogacestat for treating desmoid tumors, with a final decision expected in the third quarter of 2025. This development could lead to nirogacestat becoming the first authorized therapy for desmoid tumors in the EU. SpringWorks had also previously announced significant progress in its merger with Merck KGaA, receiving regulatory clearances from the Bundeskartellamt and the expiration of the Hart-Scott-Rodino waiting period. These recent developments highlight SpringWorks Therapeutics’ ongoing advancements in securing regulatory approvals and completing strategic mergers.
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