Broadcom named strategic vendor for Walmart virtualization solutions
STAMFORD, Conn. - The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has recommended approval of nirogacestat for treating adults with progressing desmoid tumors requiring systemic treatment, SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a $3.5 billion market cap biotech company with impressive 93% gross profit margins, announced Friday. According to InvestingPro data, the company maintains strong financial health with more cash than debt on its balance sheet.
If approved by the European Commission, which is expected to make its final decision in the third quarter of 2025, nirogacestat would become the first authorized therapy for desmoid tumors in the European Union.
The CHMP recommendation is based on results from the Phase 3 DeFi trial published in The New England Journal of Medicine. The study showed nirogacestat reduced the risk of disease progression by 71% compared to placebo and demonstrated significant improvement in objective response rate and patient-reported outcomes including pain, physical functioning and quality of life. This development has contributed to SpringWorks’ remarkable revenue growth of over 730% in the last twelve months, as reported by InvestingPro.
Desmoid tumors are rare, aggressive soft tissue tumors that can be debilitating and sometimes life-threatening. An estimated 1,300-2,300 new cases are diagnosed annually in the European Union, with higher prevalence in females.
"The positive CHMP opinion reflects the meaningful benefits nirogacestat can offer patients in Europe where currently there are no approved treatment options," said Saqib Islam, Chief Executive Officer of SpringWorks, in a press release statement.
The most common adverse reactions reported in patients receiving nirogacestat included diarrhea, ovarian toxicity, rash, nausea, fatigue, and stomatitis.
Nirogacestat previously received Orphan Drug designation from the European Commission for soft tissue sarcoma treatment and is already approved in the United States for adults with progressing desmoid tumors requiring systemic treatment. The stock has shown strong momentum with a 31% gain over the past six months. For deeper insights into SpringWorks’ financial health, growth prospects, and 6 additional exclusive ProTips, visit InvestingPro, where you’ll find comprehensive analysis in our detailed Pro Research Report.
In other recent news, SpringWorks Therapeutics has made notable strides in its merger with Merck KGaA, having received necessary regulatory clearances from German and U.S. antitrust authorities. The merger, expected to finalize in the second half of 2025, awaits shareholder approval, with a special meeting arranged to vote on the agreement. SpringWorks is also approaching a significant milestone in Europe, as the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended conditional marketing authorization for mirdametinib, a treatment for neurofibromatosis type 1. Meanwhile, H.C. Wainwright has maintained a Buy rating on SpringWorks, with a price target of $74, reflecting optimism about the potential approval of nirogacestat for desmoid tumors in Europe.
In contrast, TD Cowen has downgraded SpringWorks from Buy to Hold, adjusting the price target to $47, citing the proposed acquisition by Merck KGaA. The firm views the acquisition as strategically beneficial, enhancing Merck’s oncology portfolio without overlapping pipelines. SpringWorks recently held its annual stockholders’ meeting, where key resolutions, including the election of directors and the ratification of its accounting firm, were passed. Investors are closely monitoring these developments, as they present significant implications for SpringWorks’ strategic direction and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.