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STAMFORD, Conn. - SpringWorks Therapeutics (SWTX), a healthcare company of Merck KGaA showing remarkable growth with a 730% revenue increase in the last twelve months, announced Tuesday that long-term efficacy and safety data from its Phase 3 DeFi trial of OGSIVEO (nirogacestat) have been published in the Journal of Clinical Oncology. According to InvestingPro data, the company has achieved revenues of $219.67 million with an impressive 93.23% gross profit margin.
The data showed that extended treatment with OGSIVEO, an oral gamma secretase inhibitor approved for adults with progressing desmoid tumors requiring systemic treatment, led to further tumor size reductions and increased response rates over time.
According to the company’s press release, the objective response rate improved from 34.3% in the first year to 45.7% in patients who received the drug for up to four years. The median best reduction in tumor size deepened from -32.3% at year one to -75.8% for patients completing at least four years of treatment. This clinical success has contributed to the stock’s strong performance, with InvestingPro showing a 54% return over the past year and the stock currently trading at $46.99.
The long-term data utilized a December 2024 data cutoff date and demonstrated sustained improvement in patient-reported outcomes including pain, symptom severity, physical functioning, and quality of life.
"These data represent the largest prospective analysis from a randomized controlled clinical trial of long-term exposure to any systemic agent for desmoid tumors," said Uche Iloeje, Senior Vice President at SpringWorks Therapeutics.
The most common adverse events reported in patients receiving OGSIVEO included diarrhea, ovarian toxicity, rash, nausea, and fatigue. The company noted that the incidence and severity of frequently reported adverse events decreased through years two, three, and four of treatment.
OGSIVEO is currently approved in both the United States and European Union for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. Both the FDA and EMA have granted the drug Orphan Drug designation for this indication. For deeper insights into SpringWorks Therapeutics’ financial health and growth prospects, including exclusive ProTips and comprehensive valuation analysis, visit InvestingPro, where you’ll find detailed research reports covering 1,400+ top stocks.
In other recent news, the European Commission has granted marketing authorization for Merck’s OGSIVEO, an oral gamma secretase inhibitor, for the treatment of desmoid tumors. This approval marks OGSIVEO as the first therapy in the European Union specifically for these rare, locally aggressive tumors that affect connective tissues. Desmoid tumors are diagnosed in approximately 1,300 to 2,300 individuals annually within the EU. The approval was announced by SpringWorks Therapeutics, a healthcare company associated with Merck KGaA. This development is significant as it provides a new treatment option for adults with progressing desmoid tumors who require systemic treatment. The decision by the European Commission underscores the importance of addressing the needs of patients with rare diseases.
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