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Incyte's (INCY) Opzelura Meets Goal in Phase III Pediatric Study
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Incyte Corporation (INCY - Free Report) recently announced positive top-line results from the late-stage TRuE-AD3 study on Opzelura (ruxolitinib cream).
TRuE-AD3 (NCT04921969) is a randomized, double-blind, vehicle-controlled phase III study evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in children with atopic dermatitis (AD). The study enrolled more than 300 patients (age ≥2 to <12 years) diagnosed with AD for at least three months and who were candidates for topical therapy.
Atopic dermatitis is a chronic skin condition characterized by inflammation and itchiness, affecting approximately 13% of all children in the United States. The symptoms of AD include redness, dry skin and intense itch.
The study successfully met its primary endpoint, demonstrating that a significantly higher number of patients treated with ruxolitinib cream achieved Investigator's Global Assessment Treatment Success (IGA-TS) compared to those treated with a non-medicated cream. Patients treated with ruxolitinib cream 0.75% and 1.5% demonstrated a significantly higher treatment success rate compared to those using the non-medicated cream.
The positive results from the TRuE-AD3 study highlight the potential of ruxolitinib cream to provide an effective non-steroidal topical therapy for children suffering from this condition.
The overall safety profile of ruxolitinib cream remained consistent with previous data, with no new safety signals observed. The long-term safety portion of the study will proceed as planned.
The positive data from the TRuE-AD1 and TRuE-AD2 studies, involving adult and adolescent patients, further reinforce the potential of ruxolitinib cream as an effective topical therapy. Incyte plans to discuss these favorable results with regulatory agencies to determine the next steps in the approval process.
Opzelura, the topical cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib, has already received approval from FDA for the treatment of nonsegmental vitiligo in patients aged 12 years and older. Opzelura is also approved in the United States for the short-term and non-continuous chronic treatment of mild-to-moderate AD in non-immunocompromised patients aged 12 years and older, when other topical prescription therapies are not effective or advisable.
Opzelura cream 15mg/g is approved in Europe for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States and Europe as Opzelura.
Shares of the company are down 21.7% in the year so far compared with the industry’s decline of 10.6%.
Image Source: Zacks Investment Research
The initial uptake of Opzelura has been strong. Positive regulatory decisions would likely lead to increased uptake of Opzelura in the market, expanding the patient population that can benefit from this innovative therapy. The potential approval of Opzelura for pediatric use opens up a new market segment and presents a growth opportunity for Incyte.
We note that ruxolitinib is approved under the brand name Jakafi for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant to hydroxyurea. It is also approved for patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-PV MF and post-essential thrombocythemia MF. The drug is also approved in the United States for treating steroid-refractory acute graft versus host disease in adult and pediatric patients aged 12 years or older.
Incyte has a collaboration agreement with Swiss pharma giant Novartis (NVS - Free Report) for Jakafi.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi outside the country.
Zacks Rank and Stocks to Consider
Incyte currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Ligand Pharmaceuticals and AbbVie (ABBV - Free Report) . While Ligand currently sports a Zacks Rank #1 (Strong Buy), AbbVie carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, earnings estimates for LGND have increased by 46 cents to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 90 days, earnings estimates for ABBV have increased by 3 cents to $10.99 for 2023. ABBV surpassed estimates in all the trailing four quarters, the average surprise being 1.78%.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.
Image: Bigstock
Incyte's (INCY) Opzelura Meets Goal in Phase III Pediatric Study
Incyte Corporation (INCY - Free Report) recently announced positive top-line results from the late-stage TRuE-AD3 study on Opzelura (ruxolitinib cream).
TRuE-AD3 (NCT04921969) is a randomized, double-blind, vehicle-controlled phase III study evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in children with atopic dermatitis (AD). The study enrolled more than 300 patients (age ≥2 to <12 years) diagnosed with AD for at least three months and who were candidates for topical therapy.
Atopic dermatitis is a chronic skin condition characterized by inflammation and itchiness, affecting approximately 13% of all children in the United States. The symptoms of AD include redness, dry skin and intense itch.
The study successfully met its primary endpoint, demonstrating that a significantly higher number of patients treated with ruxolitinib cream achieved Investigator's Global Assessment Treatment Success (IGA-TS) compared to those treated with a non-medicated cream. Patients treated with ruxolitinib cream 0.75% and 1.5% demonstrated a significantly higher treatment success rate compared to those using the non-medicated cream.
The positive results from the TRuE-AD3 study highlight the potential of ruxolitinib cream to provide an effective non-steroidal topical therapy for children suffering from this condition.
The overall safety profile of ruxolitinib cream remained consistent with previous data, with no new safety signals observed. The long-term safety portion of the study will proceed as planned.
The positive data from the TRuE-AD1 and TRuE-AD2 studies, involving adult and adolescent patients, further reinforce the potential of ruxolitinib cream as an effective topical therapy. Incyte plans to discuss these favorable results with regulatory agencies to determine the next steps in the approval process.
Opzelura, the topical cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib, has already received approval from FDA for the treatment of nonsegmental vitiligo in patients aged 12 years and older. Opzelura is also approved in the United States for the short-term and non-continuous chronic treatment of mild-to-moderate AD in non-immunocompromised patients aged 12 years and older, when other topical prescription therapies are not effective or advisable.
Opzelura cream 15mg/g is approved in Europe for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States and Europe as Opzelura.
Shares of the company are down 21.7% in the year so far compared with the industry’s decline of 10.6%.
Image Source: Zacks Investment Research
The initial uptake of Opzelura has been strong. Positive regulatory decisions would likely lead to increased uptake of Opzelura in the market, expanding the patient population that can benefit from this innovative therapy. The potential approval of Opzelura for pediatric use opens up a new market segment and presents a growth opportunity for Incyte.
We note that ruxolitinib is approved under the brand name Jakafi for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant to hydroxyurea. It is also approved for patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-PV MF and post-essential thrombocythemia MF. The drug is also approved in the United States for treating steroid-refractory acute graft versus host disease in adult and pediatric patients aged 12 years or older.
Incyte has a collaboration agreement with Swiss pharma giant Novartis (NVS - Free Report) for Jakafi.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi outside the country.
Zacks Rank and Stocks to Consider
Incyte currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Ligand Pharmaceuticals and AbbVie (ABBV - Free Report) . While Ligand currently sports a Zacks Rank #1 (Strong Buy), AbbVie carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, earnings estimates for LGND have increased by 46 cents to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 90 days, earnings estimates for ABBV have increased by 3 cents to $10.99 for 2023. ABBV surpassed estimates in all the trailing four quarters, the average surprise being 1.78%.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.