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INCY Obtains FDA Approval for Label Expansion of Ruxolitinib Cream
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Key Takeaways
{\"0\":\"Incyte gained FDA approval for Opzelura to treat pediatric atopic dermatitis from age two. \\r\\n\",\"1\":\"Approval was backed by TRuE-AD3 trial showing efficacy and consistent safety results.\",\"2\":\"Opzelura sales hit $283.2M in 1H1 2025, up 37%, with label expansion set to drive further growth. \"}
Incyte (INCY - Free Report) announced that the FDA has approved the label expansion of Opzelura (ruxolitinib) cream 1.5%.
Opzelura, a topical Janus kinase (JAK) inhibitor, is now approved for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended.
Per INCY, Opzelura is the first topical JAK inhibitor approved in the United States for pediatric AD.
More on INCY’s Opzelura
The FDA approval of Opzelura was based on positive data from the phase III TRuE-AD3 study, which evaluated the safety and efficacy of ruxolitinibcream in children (age ≥2 to <12 years) with AD.
This study met its primary endpoint with significantly more patients treated with Opzelura achieving Investigator’s Global Assessment-treatment success, a measure of treatment efficacy, than those treated with vehicle control (non-medicated cream). In addition, a secondary endpoint of patients demonstrating at least a 75% improvement in the Eczema Area and Severity Index at week 8 was also achieved.
The overall safety profile of Opzelura in the TRuE-AD3 study was consistent with previous data, and no new safety signals were observed.
The latest FDA decision marks Opzelura’s third U.S. approval.
Sales of Opzelura totaled $283.2 million in the first half of 2025, up 37% year over year.
Incyte Corporation Price, Consensus and EPS Surprise
In September 2021, Opzelura was approved by the FDA for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
Subsequently, the FDA expanded Opzelura’s label In July 2022 for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
INCY’s Focus on Diversification of Revenue Base
While the uptake of recently approved drugs (Pemazyre, Monjuvi and Tabrecta) has been strong and potential approvals of additional drugs could further diversify its portfolio, INCY remains heavily dependent on its lead drug, Jakafi, for top-line growth.
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.
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.
Hence, the company is looking to diversify its revenue base.
Year to date, shares of the company have gained 24.5% compared with the industry’s growth of 6%.
Image Source: Zacks Investment Research
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, a group of rare blood cancers.
Per the agreement with Incyte, QIAGEN will develop a multimodal panel utilizing next-generation sequencing 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.
Image: Bigstock
INCY Obtains FDA Approval for Label Expansion of Ruxolitinib Cream
Key Takeaways
Incyte (INCY - Free Report) announced that the FDA has approved the label expansion of Opzelura (ruxolitinib) cream 1.5%.
Opzelura, a topical Janus kinase (JAK) inhibitor, is now approved for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended.
Per INCY, Opzelura is the first topical JAK inhibitor approved in the United States for pediatric AD.
More on INCY’s Opzelura
The FDA approval of Opzelura was based on positive data from the phase III TRuE-AD3 study, which evaluated the safety and efficacy of ruxolitinibcream in children (age ≥2 to <12 years) with AD.
This study met its primary endpoint with significantly more patients treated with Opzelura achieving Investigator’s Global Assessment-treatment success, a measure of treatment efficacy, than those treated with vehicle control (non-medicated cream). In addition, a secondary endpoint of patients demonstrating at least a 75% improvement in the Eczema Area and Severity Index at week 8 was also achieved.
The overall safety profile of Opzelura in the TRuE-AD3 study was consistent with previous data, and no new safety signals were observed.
The latest FDA decision marks Opzelura’s third U.S. approval.
Sales of Opzelura totaled $283.2 million in the first half of 2025, up 37% year over year.
Incyte Corporation Price, Consensus and EPS Surprise
Incyte Corporation price-consensus-eps-surprise-chart | Incyte Corporation Quote
The label expansion of the drug will boost sales.
In September 2021, Opzelura was approved by the FDA for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
Subsequently, the FDA expanded Opzelura’s label In July 2022 for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
INCY’s Focus on Diversification of Revenue Base
While the uptake of recently approved drugs (Pemazyre, Monjuvi and Tabrecta) has been strong and potential approvals of additional drugs could further diversify its portfolio, INCY remains heavily dependent on its lead drug, Jakafi, for top-line growth.
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.
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.
Hence, the company is looking to diversify its revenue base.
Year to date, shares of the company have gained 24.5% compared with the industry’s growth of 6%.
Image Source: Zacks Investment Research
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, a group of rare blood cancers.
Per the agreement with Incyte, QIAGEN will develop a multimodal panel utilizing next-generation sequencing 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 currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.