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 over the next 12 months. According to Wall Street analysts, the average 1-year price target for INCY is 100.31 USD with a low forecast of 73.00 USD and a high forecast of 125.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
19 Analyst Rating
9 Buy
9 Hold
1 Sell
Moderate Buy
Current: 102.760
Low
73.00
Averages
100.31
High
125.00
Current: 102.760
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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- Innovative Treatment Combination: The therapy is recommended in combination with platinum-based chemotherapy for squamous cell carcinoma of the anal canal (SCAC), which accounts for 85% of anal cancer cases; despite being rare, its incidence is rising by approximately 3% annually, indicating potential market demand.
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See More
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- Cisco's AI Focus: Cisco anticipates earnings of $1.02 per share and revenue of $15.1 billion for Q2 FY2026, with CEO highlighting a major multi-year campus networking refresh, making AI infrastructure demand a critical growth driver.
- Importance of Employment Report: The January employment report is expected to show an addition of 80,000 nonfarm payrolls and an unchanged unemployment rate of 4.4%, directly impacting private consumption and U.S. GDP, making it crucial for investors to monitor.
- Consumer Price Index Insights: The January CPI is projected to increase by 2.5% year-over-year, with core CPI rising by 2.6%, providing essential inflation details despite not being the Fed's preferred measure, particularly regarding persistent shelter cost inflation.
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- Inflation Metrics Analysis: The January Consumer Price Index is projected to rise by 0.29% month-over-month and 2.5% year-over-year, showing improvement but still falling short of the Fed's 2% target, potentially affecting investor rate expectations.
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- Analyst Rating Updates: Top Wall Street analysts have adjusted their ratings on several companies, reflecting the latest market sentiment towards these stocks, although specific names were not disclosed, investors should pay attention to these changes for informed decision-making.
- Impact of Rating Changes: Upgrades or downgrades in ratings can directly influence the market performance of the related stocks, prompting investors to closely monitor these shifts to timely adjust their portfolios for optimized returns.
- Market Reaction Expectations: Analyst rating adjustments often trigger immediate market reactions, particularly when investors have a high level of interest in specific stocks, potentially leading to short-term price volatility.
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See More
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- FDA Trial Approval: Prelude Therapeutics has received FDA clearance to advance its blood cancer candidate PRT12396 into early-stage trials, marking a significant milestone in the company's efforts in hematologic oncology.
- Targeting Specific Cancer Types: PRT12396 is designed to treat a group of blood cancers known as myeloproliferative neoplasms, specifically targeting high-risk polycythemia vera and intermediate to high-risk myelofibrosis, with dosing expected to commence in Q2 2026.
- Multi-Center Study Design: The open-label, multi-center study aims to evaluate the safety and efficacy of PRT12396, with primary endpoints focusing on drug tolerability and effectiveness, laying the groundwork for future clinical applications.
- Gene-Targeted Therapy: PRT12396 is part of Prelude's JAK2V617F JH2 inhibitor program, targeting the key genetic mutation responsible for the progression of most myeloproliferative neoplasms, highlighting the company's strategic positioning in precision medicine.
See More
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- New Indication Endorsement: Incyte's Zynyz (retifanlimab), marketed in collaboration with MacroGenics, has received endorsement from the European Medicines Agency (EMA) expert panel as a first-line treatment option for certain adults with squamous cell carcinoma, marking a significant advancement in cancer therapy.
- Innovative Treatment Combination: The therapy is recommended in combination with platinum-based chemotherapy for squamous cell carcinoma of the anal canal (SCAC), which accounts for 85% of anal cancer cases; despite being rare, its incidence is rising by approximately 3% annually, indicating potential market demand.
- Current Market Status: Zynyz is already available in the EU as a single-agent first-line treatment for certain cases of Merkel cell carcinoma, and this new indication will further expand its market application, enhancing the company's competitiveness in cancer treatment.
- Approval Process Ahead: The EMA's Committee for Medicinal Products for Human Use (CHMP) recommendation will be reviewed by the European Commission (EC) for final approval, which, if granted, could provide Incyte with a new revenue stream and strengthen its market position.
See More
