Incyte reports success in lymphoma trial, plans FDA application By Investing.com

WILMINGTON, Del. – Incyte (NASDAQ:) announced positive outcomes from its Phase 3 inMIND trial, which evaluated the effectiveness and safety of the drug tafasitamab in patients with relapsed or refractory follicular lymphoma (FL). The trial achieved its primary goal of progression-free survival (PFS) and also met key secondary endpoints, including PFS in the overall population and complete response rates as determined by positron-emission tomography.

Tafasitamab, marketed as Monjuvi® in the United States and Minjuvi® in Europe and Canada, is a monoclonal antibody that targets CD19, a protein expressed on the surface of B-cells. The trial’s positive results have led Incyte to plan for a supplemental Biologics License Application submission for tafasitamab’s use in FL by the end of the year.

Follicular lymphoma, a slow-growing form of B-cell non-Hodgkin lymphoma, accounts for a significant portion of NHL cases. Despite initial treatments, many patients experience a relapse, highlighting the need for additional therapeutic options. The inMIND study, which is set to be presented at an upcoming scientific meeting, compared the efficacy of tafasitamab combined with lenalidomide and rituximab against a control group receiving only lenalidomide and rituximab.

Incyte’s Chief Medical Officer, Steven Stein, M.D., emphasized the potential of tafasitamab to become a meaningful new treatment for FL patients who have seen their disease progress after previous therapies. The study reported no new safety concerns associated with tafasitamab, which was previously approved in combination with lenalidomide for a different type of lymphoma in both the U.S. and Europe.

The inMIND trial enrolled 654 adults with relapsed or refractory FL or marginal zone lymphoma (MZL), assessing the clinical benefit of adding tafasitamab to the existing treatment regimen. As the company prepares for regulatory submission, the latest findings could represent a significant step forward in the management of follicular lymphoma.

The information in this article is based on a press release statement from Incyte.

In other recent news, Syndax Pharmaceuticals (NASDAQ:) and Incyte Corporation have seen significant developments. The U.S. Food and Drug Administration (FDA) has approved Syndax’s Niktimvo for use in third-line or higher chronic graft versus host disease (cGvHD), leading Citi to raise its price target on the company’s stock from $30 to $34. The company plans to launch Niktimvo between the fourth quarter of 2024 and the first quarter of 2025. Meanwhile, Incyte Corporation’s axatilimab, now branded as Niktimvo, has also been approved by the FDA. RBC Capital Markets has subsequently increased Incyte’s price target from $66 to $67, while BMO Capital Markets has maintained its underperform rating on Incyte’s shares. Incyte’s total revenues for the second quarter of 2024 reached $1.4 billion, a 9% increase from the previous year, largely driven by key products, Jakafi and Opzelura. These are recent developments in the companies’ respective trajectories.

InvestingPro Insights

As Incyte (NASDAQ:INCY) prepares for a supplemental Biologics License Application submission for tafasitamab, the company’s financial health and market performance provide additional context for potential investors. According to InvestingPro, Incyte holds more cash than debt on its balance sheet, a position that may offer financial flexibility as the company advances its clinical programs. Moreover, management’s aggressive share buyback strategy indicates confidence in the company’s prospects, potentially signaling a positive outlook to investors.

In terms of market performance, Incyte’s market capitalization stands at $11.87 billion, reflecting its substantial presence in the biopharmaceutical sector. However, the company is trading at a high earnings multiple, with a P/E ratio of 140.78, suggesting investors have high expectations for future earnings growth. Despite a challenging market environment, Incyte’s stock has shown low price volatility, which might appeal to investors looking for stability in the biotech industry.

For those interested in a deeper dive into Incyte’s financials and market performance, there are 11 additional InvestingPro Tips available, providing a comprehensive analysis of the company’s outlook. Additionally, Incyte’s fair value is estimated at $82.36 according to InvestingPro, which is above the current trading price, indicating potential undervaluation. With these insights in hand, investors can better assess how the latest clinical developments might impact Incyte’s financial future.

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