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COPENHAGEN - Genmab A/S (Nasdaq:GMAB), a $13.2 billion market cap biotech company with impressive 25% revenue growth over the last twelve months, announced Thursday that its Phase 3 EPCORE FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) demonstrated significant improvements over R2 alone in patients with relapsed or refractory follicular lymphoma.
The study met both primary endpoints, showing a 95.7% overall response rate (p
The U.S. Food and Drug Administration has accepted for priority review the supplemental Biologics License Application for this combination therapy, with a target action date of November 30, 2025.
If approved, epcoritamab plus R2 would become the first bispecific antibody combination regimen available as a second-line treatment option for patients with relapsed or refractory follicular lymphoma in the United States.
"While therapeutic options exist for patients with relapsed or refractory follicular lymphoma, response rates tend to decline and durability diminishes with each subsequent line of treatment," said Jan van de Winkel, Chief Executive Officer of Genmab, according to the press release. The company’s strong market position is reflected in its financial health, earning a "GREAT" overall score from InvestingPro, which identifies the stock as currently undervalued based on its comprehensive Fair Value analysis.
The safety profile of the combination therapy was consistent with the known profiles of the individual components, with no new safety signals observed.
Follicular lymphoma is the second most common form of non-Hodgkin’s lymphoma, accounting for 20-30 percent of all cases. Approximately 15,000 people develop this slow-growing, typically incurable form of lymphoma each year in the U.S.
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and is being co-developed with AbbVie as part of the companies’ oncology collaboration. Investors seeking deeper insights into Genmab’s financial health and growth potential can access the comprehensive Pro Research Report, available exclusively on InvestingPro, which includes detailed analysis of the company’s strong cash flow position and market opportunities.
The results from this trial will be submitted for presentation at the upcoming American Society of Hematology Annual Meeting and will serve as the basis for global regulatory submissions.
In other recent news, Genmab A/S announced the completion of its share buy-back program, repurchasing 2.2 million shares valued at approximately 2.86 billion Danish kroner. The program concluded ahead of schedule, with the final transactions occurring between June 23-26, 2025. Truist Securities raised its price target for Genmab to $46, maintaining a Buy rating, citing a strong revenue outlook for 2025 driven by the performance of the cancer drug Darzalex. Genmab also disclosed details of its share buy-back activities, which were part of a regulatory filing with the U.S. Securities and Exchange Commission. Additionally, the company granted restricted stock units and warrants to employees as part of its long-term incentive plan. The grants include 3,320 restricted stock units and 3,636 warrants, aligning employee and shareholder interests. These units, awarded at no cost to employees, will vest after three years. The recent developments reflect Genmab’s strategic initiatives in shareholder value and employee incentives.
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