COPENHAGEN - The European Commission has granted conditional marketing authorization to Genmab (NASDAQ:GMAB) A/S's TEPKINLY (epcoritamab), making it the first subcutaneous bispecific antibody approved in the European Union for monotherapy treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after at least two lines of systemic therapy. This approval also extends to the European Economic Area countries and Northern Ireland.
Follicular lymphoma, a typically slow-growing form of non-Hodgkin's lymphoma, accounts for 20-30% of all non-Hodgkin's lymphoma cases and is considered incurable with no standard third-line treatment. The authorization of TEPKINLY offers a new treatment option for patients who have exhausted other therapies and often face relapse.
The approval is based on data from the Phase 1/2 EPCORE NHL-1 clinical trial, which showed an overall response rate of 83% and a complete response rate of 63% in patients treated with TEPKINLY. At a median follow-up of 16.2 months, the median duration of response was 21.4 months, with the duration of complete response not yet reached. The trial also demonstrated a favorable safety profile, with the most common adverse reactions being cytokine release syndrome, injection site reactions, and fatigue.
Genmab, in partnership with AbbVie (NYSE:ABBV), is committed to further development of epcoritamab as a potential core therapy for B-cell malignancies. The companies plan to pursue additional international regulatory approvals for R/R FL and R/R diffuse large B-cell lymphoma (DLBCL) indications.
The approval has been welcomed by the lymphoma community, as it represents a significant advancement in the treatment options available for patients with this challenging form of cancer.
This news article is based on a press release statement from Genmab A/S, an international biotechnology company focused on developing innovative antibody therapeutics for cancer treatment. The information provided here is intended for general informational purposes and should not be considered as medical advice. The safety and efficacy of TEPKINLY for investigational uses have not been established. For detailed safety information, please refer to the full Summary of Product Characteristics or the prescribing information in your region.
In other recent news, Genmab A/S has reported a capital increase resulting from employee warrant exercises. This development is part of the company's internal incentive programs aimed at retaining employees. The company has not disclosed the number of warrants exercised or the amount of capital raised. Genmab, known for its work in the development of antibody therapeutics, has also disclosed transactions with shares and linked securities by managerial employees and their closely associated persons.
In financial news, Genmab has reported strong financial results for the first half of 2024, with a significant revenue growth of 36% to over DKK 9.5 billion and a 29% increase in operating profit to DKK 2.4 billion. The company's drugs, DARZALEX, KESIMPTA, and EPKINLY, have contributed significantly to these figures. Genmab has also completed the acquisition of ProfoundBio, which is expected to enhance its long-term growth potential.
Despite potential volatility in their tax rate due to the integration of ProfoundBio operations, Genmab anticipates this to normalize within 12 to 18 months. The company is not actively seeking a partner for acasunlimab but may consider regional partnerships in the future. These are among the recent developments at Genmab.
InvestingPro Insights
In light of Genmab A/S's recent European Commission approval for TEPKINLY, the company's financial health and stock performance become a focal point for investors. Genmab's market capitalization stands at a robust 17.47 billion USD, reflecting investor confidence in the company's value and growth potential. The company's P/E ratio, a key indicator of investor expectations for earnings growth, is 21.76, aligning with industry standards and suggesting a balanced valuation relative to its earnings.
Significantly, Genmab holds more cash than debt on its balance sheet, a strong indicator of financial stability and an InvestingPro Tip that highlights the company's solid liquidity position. This financial footing could be instrumental in supporting ongoing research and development efforts, such as the further development of epcoritamab for B-cell malignancies. Additionally, Genmab's revenue growth over the last twelve months has been impressive at 17.19%, signaling a healthy increase in the company's financial inflows, which is essential for fuelling its strategic initiatives.
Investors may also take note of another InvestingPro Tip: Genmab's management has been actively engaging in share buybacks, a move that often reflects leadership's belief in the company's future prospects and can be seen as a positive sign for shareholders. For those looking to delve deeper into the company's financials and stock performance, there are over 10 additional InvestingPro Tips available at https://www.investing.com/pro/GMAB, offering comprehensive insights into Genmab's market position and future outlook.
With Genmab's commitment to advancing cancer treatment and its strong financial metrics, the company appears well-positioned to navigate the competitive landscape of the biotechnology industry and deliver value to both patients and investors alike.
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