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INCY Stock Trading Close to Its 52-Week High: Buy, Sell or Hold?
Read MoreHide Full Article
Key Takeaways
Incyte touched a 52-week high of $87.24 on Aug. 18 after strong results and pipeline progress.
Jakafi sales rose 15% to $1.5B in 1H 2025, while Opzelura jumped 37% to $283M.
FDA approvals for Monjuvi and Zynyz expand Incytes oncology portfolio and boost growth.
Incyte ((INCY - Free Report) ) has put up a stupendous performance in the past month and touched a new 52-week high of $87.24 on Aug. 18. Nonetheless, the stock price dipped to $85.46 on the following day. Shares of the company have gained 26.8% compared to the industry’s gain of 6.3%.
The stock has also outperformed the sector in the aforementioned timeframe.
Image Source: Zacks Investment Research
INCY Outperforms Industry, Sector & S&P 500 Index
The recent rally can be attributed to positive investor sentiment around INCY. Last month, the company reported better-than-expected second-quarter results. The recent pipeline progress has been impressive as well.
Let’s delve deeper and analyze the company’s strengths and weaknesses to understand how to play the stock in such a scenario.
INCY’s Lead Drug Jakafi Maintains Momentum
Incyte’s lead drug, Jakafi, is a JAK1/JAK2 inhibitor approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.
Sales in all indications continue to be strong and should maintain momentum going forward.
Jakafi sales in the first half of 2025 were up 15% to $1.5 billion.
Jakafi is marketed by Incyte in the United States and by Novartis ((NVS - Free Report) ) as Jakavi in ex-U.S. markets. Incyte earns royalties from NVS on sales outside the country.
The FDA’s approval of the cream formulation of ruxolitinib for the treatment of mild to moderate atopic dermatitis (AD), under the brand name Opzelura, has been a significant boost for the company. The drug has also been approved for the topical treatment of non-segmental vitiligo in adult and pediatric patients aged 12 years and above. The approval makes Opzelura the first and only topical formulation of a JAK inhibitor approved in the United States. The uptake of Opzelura has been strong, driven by increased patient demand and refills in both atopic dermatitis (AD) and vitiligo.
Opzelura sales jumped 37% year over year to $283 million in the first half of 2025.
Pipeline/Regulatory Updates Boost INCY Stock
Incyte’s efforts to develop new drugs to diversify its portfolio and add an incremental stream of revenues are impressive.
Encouraging uptake of new drugs like Pemazyre, Monjuvi and Tabrecta also contributes to its top-line growth.
The FDA had earlier approved Monjuvi (tafasitamab-cxix) for a new cancer indication.
Monjuvi, in combination with Rituxan (rituximab) and Revlimid (lenalidomide), was approved for the treatment of adult patients with relapsed or refractory follicular lymphoma, a type of slow-growing blood cancer.
The drug is already approved, in combination with Revlimid, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.
Incyte gained worldwide exclusive global rights for tafasitamab from MorphoSys AG in February 2024. Tafasitamab is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets.
The label expansion of the drug should boost sales of the drug.
In May 2025, the FDA approved a label expansion of oncology drug Zynyz (retifanlimab-dlwr), a PD-1 inhibitor. The regulatory body has now approved Zynyz in combination with chemotherapy and as a single agent for the treatment of adult patients with advanced squamous cell carcinoma of the anal canal (SCAC).
Zynyz is also indicated in the United States for the treatment of adult patients with metastatic or recurrent locally advanced merkel cell carcinoma.
Earlier, INCY’s new global collaboration with Qiagen ((QGEN - Free Report) ) also impressed investors.
The collaboration is aimed at developing a novel diagnostic panel to support INCY’s pipeline of investigational treatments for myeloproliferative neoplasms (MPNs), a group of rare blood cancers.
Per the agreement with Incyte, QIAGEN will develop a multimodal panel utilizing next-generation sequencing (NGS) technology to detect clinically relevant gene alterations in hematological malignancies. QIAGEN will also assist with regulatory submissions and market access efforts in the United States, the EU and certain Asia-Pacific regions.
INCY’s Dependence on Jakafi
While the uptake of recently approved drugs has been good and a potential approval of the additional drugs should diversify its portfolio, INCY is heavily dependent on Jakafi for its top-line growth.
Moreover, competition has increased for some of Jakafi’s approved indications. The FDA’s approval of GSK plc’s (GSK) Ojjaara for the treatment of intermediate or high-risk MF, including primary MF or secondary MF (post-polycythemia vera and post-essential thrombocythaemia) in adults with anemia, poses competition.
Jakafi is also expected to lose patent protection in a few years. The FDA recently extended the review period for the supplemental new drug application (sNDA) for ruxolitinib cream seeking approval for the treatment of children 2-11 years old with mild to moderate AD.
The target action date has been extended by three months to Sept. 19, 2025, to provide the FDA with the time to review additional chemistry, manufacturing and controls data on the 0.75% strength submitted by Incyte in response to a recent information request by the regulatory body.
Valuation & Estimates
Going by the price/earnings ratio, INCY is still inexpensive. INCY’s shares currently trade at 12.25x forward earnings, lower than its mean of 20.83x and 14.56x for the large-cap pharma biotech industry.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2025 earnings per share (EPS) has moved north to $6.07 from $5.77 over the past 30 days. During the same timeframe, the EPS estimate for 2026 has jumped 36 cents to $7.49.
Image Source: Zacks Investment Research
Stay Invested in INCY
Incyte’s recent robust rally is positive, and potential label expansion of existing drugs and the launch of new drugs should generate incremental revenues and drive share price gains.
However, generic competition for Jakafi is a major headwind as it accounts for more than 70% of total revenues.
Incyte has recently appointed Bill Meury as its president and chief executive officer (CEO). With a new CEO at the helm, we advise a wait-and-watch stance for prospective investors as of now. Existing investors can stay invested for the time being, as large biotechs are considered safe havens for investors in this sector.
Image: Bigstock
INCY Stock Trading Close to Its 52-Week High: Buy, Sell or Hold?
Key Takeaways
Incyte ((INCY - Free Report) ) has put up a stupendous performance in the past month and touched a new 52-week high of $87.24 on Aug. 18. Nonetheless, the stock price dipped to $85.46 on the following day. Shares of the company have gained 26.8% compared to the industry’s gain of 6.3%.
The stock has also outperformed the sector in the aforementioned timeframe.
Image Source: Zacks Investment Research
INCY Outperforms Industry, Sector & S&P 500 Index
The recent rally can be attributed to positive investor sentiment around INCY. Last month, the company reported better-than-expected second-quarter results. The recent pipeline progress has been impressive as well.
Let’s delve deeper and analyze the company’s strengths and weaknesses to understand how to play the stock in such a scenario.
INCY’s Lead Drug Jakafi Maintains Momentum
Incyte’s lead drug, Jakafi, is a JAK1/JAK2 inhibitor approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.
Sales in all indications continue to be strong and should maintain momentum going forward.
Jakafi sales in the first half of 2025 were up 15% to $1.5 billion.
Jakafi is marketed by Incyte in the United States and by Novartis ((NVS - Free Report) ) as Jakavi in ex-U.S. markets. Incyte earns royalties from NVS on sales outside the country.
The FDA’s approval of the cream formulation of ruxolitinib for the treatment of mild to moderate atopic dermatitis (AD), under the brand name Opzelura, has been a significant boost for the company. The drug has also been approved for the topical treatment of non-segmental vitiligo in adult and pediatric patients aged 12 years and above. The approval makes Opzelura the first and only topical formulation of a JAK inhibitor approved in the United States. The uptake of Opzelura has been strong, driven by increased patient demand and refills in both atopic dermatitis (AD) and vitiligo.
Opzelura sales jumped 37% year over year to $283 million in the first half of 2025.
Pipeline/Regulatory Updates Boost INCY Stock
Incyte’s efforts to develop new drugs to diversify its portfolio and add an incremental stream of revenues are impressive.
Encouraging uptake of new drugs like Pemazyre, Monjuvi and Tabrecta also contributes to its top-line growth.
The FDA had earlier approved Monjuvi (tafasitamab-cxix) for a new cancer indication.
Monjuvi, in combination with Rituxan (rituximab) and Revlimid (lenalidomide), was approved for the treatment of adult patients with relapsed or refractory follicular lymphoma, a type of slow-growing blood cancer.
The drug is already approved, in combination with Revlimid, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.
Incyte gained worldwide exclusive global rights for tafasitamab from MorphoSys AG in February 2024. Tafasitamab is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets.
The label expansion of the drug should boost sales of the drug.
In May 2025, the FDA approved a label expansion of oncology drug Zynyz (retifanlimab-dlwr), a PD-1 inhibitor. The regulatory body has now approved Zynyz in combination with chemotherapy and as a single agent for the treatment of adult patients with advanced squamous cell carcinoma of the anal canal (SCAC).
Zynyz is also indicated in the United States for the treatment of adult patients with metastatic or recurrent locally advanced merkel cell carcinoma.
Earlier, INCY’s new global collaboration with Qiagen ((QGEN - Free Report) ) also impressed investors.
The collaboration is aimed at developing a novel diagnostic panel to support INCY’s pipeline of investigational treatments for myeloproliferative neoplasms (MPNs), a group of rare blood cancers.
Per the agreement with Incyte, QIAGEN will develop a multimodal panel utilizing next-generation sequencing (NGS) technology to detect clinically relevant gene alterations in hematological malignancies. QIAGEN will also assist with regulatory submissions and market access efforts in the United States, the EU and certain Asia-Pacific regions.
INCY’s Dependence on Jakafi
While the uptake of recently approved drugs has been good and a potential approval of the additional drugs should diversify its portfolio, INCY is heavily dependent on Jakafi for its top-line growth.
Moreover, competition has increased for some of Jakafi’s approved indications. The FDA’s approval of GSK plc’s (GSK) Ojjaara for the treatment of intermediate or high-risk MF, including primary MF or secondary MF (post-polycythemia vera and post-essential thrombocythaemia) in adults with anemia, poses competition.
Jakafi is also expected to lose patent protection in a few years. The FDA recently extended the review period for the supplemental new drug application (sNDA) for ruxolitinib cream seeking approval for the treatment of children 2-11 years old with mild to moderate AD.
The target action date has been extended by three months to Sept. 19, 2025, to provide the FDA with the time to review additional chemistry, manufacturing and controls data on the 0.75% strength submitted by Incyte in response to a recent information request by the regulatory body.
Valuation & Estimates
Going by the price/earnings ratio, INCY is still inexpensive. INCY’s shares currently trade at 12.25x forward earnings, lower than its mean of 20.83x and 14.56x for the large-cap pharma biotech industry.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2025 earnings per share (EPS) has moved north to $6.07 from $5.77 over the past 30 days. During the same timeframe, the EPS estimate for 2026 has jumped 36 cents to $7.49.
Image Source: Zacks Investment Research
Stay Invested in INCY
Incyte’s recent robust rally is positive, and potential label expansion of existing drugs and the launch of new drugs should generate incremental revenues and drive share price gains.
However, generic competition for Jakafi is a major headwind as it accounts for more than 70% of total revenues.
Incyte has recently appointed Bill Meury as its president and chief executive officer (CEO). With a new CEO at the helm, we advise a wait-and-watch stance for prospective investors as of now. Existing investors can stay invested for the time being, as large biotechs are considered safe havens for investors in this sector.
INCY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.