Zynyz® Receives Positive Opinion for SCAC Treatment in Europe
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 30 2026
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Should l Buy INCY?
Source: Newsfilter
- Therapeutic Innovation: Zynyz® (retifanlimab) in combination with platinum-based chemotherapy has received a positive opinion from the EMA's CHMP, marking it as the first PD-1 immunotherapy for advanced squamous cell carcinoma of the anal canal (SCAC) in Europe, which is expected to significantly enhance treatment options for patients.
- Clinical Trial Results: Data from the POD1UM-303/InterAACT2 trial showed that patients receiving Zynyz with platinum-based chemotherapy achieved a median progression-free survival of 9.3 months compared to 7.4 months in the placebo group, indicating a significant 37% reduction in the risk of progression or death, highlighting its therapeutic advantage.
- Market Potential: With SCAC's global prevalence estimated at 1 to 2 cases per 100,000 people, and a higher incidence in women, the approval of Zynyz is poised to fill a critical gap in the treatment landscape for this rare cancer, potentially establishing a new standard of care to meet the urgent demand for innovative therapies.
- Safety Assessment: Among patients treated with Zynyz and chemotherapy, 47% experienced serious adverse reactions, primarily sepsis and pulmonary embolism; however, no new safety signals were identified, indicating an acceptable safety profile for this treatment regimen.
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Analyst Views on INCY
Wall Street analysts forecast INCY stock price to fall
19 Analyst Rating
9 Buy
9 Hold
1 Sell
Moderate Buy
Current: 100.750
Low
73.00
Averages
100.31
High
125.00
Current: 100.750
Low
73.00
Averages
100.31
High
125.00
About INCY
Incyte Corporation is a biopharmaceutical company, which is focused on the discovery, development, and commercialization of therapeutics. The Company operates in two therapeutic areas. One therapeutic area is Hematology/Oncology, which is comprised of Myeloproliferative Neoplasms and Graft-Versus-Host Disease, as well as solid tumors and hematologic malignancies. Its other therapeutic area is Inflammation and Autoimmunity, which includes its Dermatology commercial franchise. Its hematology and oncology franchise are comprised of six products, which are JAKAFI (ruxolitinib), MONJUVI (tafasitamab-cxix)/MINJUVI (tafasitamab), PEMAZYRE (pemigatinib), ICLUSIG (ponatinib), NIKTIMVO (axatilimab-csfr), and ZYNYZ (retifanlimab-dlwr), as well as numerous clinical development programs. The Company's pipeline also includes two first-in-class small molecule antagonist of Mas-related G protein-coupled receptor (MRGPRX2) and INCB000547, an oral MRGPRX4 antagonist.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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