FDA approves new anal cancer treatment Zynyz by Incyte

WILMINGTON, Del. - Incyte (NASDAQ:INCY), a $12.1 billion biopharmaceutical company with strong financial health according to InvestingPro metrics, has received U.S. Food and Drug Administration (FDA) approval for Zynyz® (retifanlimab-dlwr), a PD-1 inhibitor, for use in combination with chemotherapy and as a monotherapy for advanced squamous cell carcinoma of the anal canal (SCAC). This marks a significant advancement for patients with SCAC, providing a new treatment option for a disease with historically limited therapeutic innovations. The company maintains a robust balance sheet with more cash than debt, positioning it well for continued innovation.

The FDA’s decision was based on results from two clinical trials: the Phase 3 POD1UM-303/InterAACT2 trial, which demonstrated a 37% reduction in the risk of disease progression or death for patients treated with Zynyz in combination with platinum-based chemotherapy, and the Phase 2 POD1UM-202 trial, which evaluated Zynyz monotherapy. Patients treated with the combination therapy achieved a median progression-free survival of 9.3 months compared to 7.4 months with the placebo, and a 6.2-month improvement in median overall survival (OS) was observed at an interim analysis. This development comes as Incyte reports impressive revenue growth of 17% year-over-year, with analysts on InvestingPro expecting continued profit growth this year.

Serious adverse reactions occurred in 47% of patients receiving Zynyz with chemotherapy, with the most frequent being sepsis, pulmonary embolism, diarrhea, and vomiting. Zynyz monotherapy, intended for patients with disease progression on or intolerance to platinum-based chemotherapy, showed an objective response rate of 14% and a disease control rate of 49%, with a safety profile consistent with PD-1 inhibitors.

The approval of Zynyz is seen as a pivotal moment for those affected by SCAC, a condition that typically presents with advanced disease and is often associated with human papillomavirus (HPV) infection. The Anal Cancer Foundation has welcomed the approval, emphasizing the importance of new treatment approaches for this challenging cancer.

Incyte’s commitment to patient support is evident through its IncyteCARES program, which provides financial assistance and education to eligible patients in the U.S. prescribed Zynyz.

This approval may represent an important step forward for Incyte and patients with SCAC, offering new hope where treatment options were previously limited. According to InvestingPro analysis, Incyte appears undervalued at its current price of $62.50, with analyst targets ranging from $52 to $95 per share. The company’s strong financial position and growth prospects make it an interesting case study among healthcare stocks. For detailed insights into Incyte and similar opportunities, investors can access comprehensive Pro Research Reports covering 1,400+ top US stocks on InvestingPro. The information in this article is based on a press release statement and financial data from InvestingPro.

In other recent news, Incyte Corporation has reported first-quarter earnings for 2025 that exceeded expectations, with an earnings per share of $1.16 and revenue of $1.05 billion, surpassing the forecasted figures. Jakafi, a key product for Incyte, generated $709 million in revenue, beating both BofA Securities’ projection and the consensus estimate. The company has consequently raised its full-year revenue guidance for Jakafi to a range of $2.95 to $3 billion, attributing this to increased demand and favorable Medicare Part D impacts. Incyte has also resolved a royalty dispute with Novartis by agreeing to a $280 million settlement, which will result in a $242.2 million difference reflected in their financial statements for the quarter ending June 30, 2025.

BofA Securities recently raised its price target on Incyte’s stock to $89, maintaining a Buy rating, following the company’s strong financial performance. Despite a decline in Opzelura revenues, Incyte remains optimistic about the product’s future, particularly with its expansion into pediatric atopic dermatitis. The company also reported a successful launch of Nictimvo for third-line chronic graft-versus-host disease, contributing $14 million in revenue in its initial months. These developments highlight Incyte’s strong commercial performance and strategic foresight, positioning it favorably for future growth.

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