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Arcutis (ARQT) Up on Top-Line Data From Atopic Dermatitis Study
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Arcutis Biotherapeutics (ARQT - Free Report) recently announced top-line data from its phase III INTEGUMENT-1 pivotal study of roflumilast cream 0.15% to treat mild to moderate atopic dermatitis (AD) in adults and children more than six years.
Roflumilast, the company’s lead candidate, is a non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor.
Atopic dermatitis is a chronic skin disease characterized by itchy and inflamed skin, common mainly in children. Per the company, the disease needs rapid-acting topical treatment options since the available treatment with corticosteroids causes major side effects.
The INTEGUMENT-1 study met its primary endpoint, with 32% of the individuals treated with roflumilast cream 0.15% achieving Investigator Global Assessment (IGA) Success - AD score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline, at week four compared with 15.2% of the subjects treated with a vehicle. The ointment was also well tolerated by the subjects.
The study achieved all its secondary endpoints. 43.2% of the subjects treated with the roflumilast 0.15% cream achieved a 75% reduction in Eczema Area and Severity Index (EASI) at week four compared with 22% treated with vehicle.
The study also measured the reduction in itchiness in children 12 years and older. Of the subjects, 33.6% treated with the candidate achieved a four-point reduction in Itch Numeric Scale (WI-NRS) at week four compared with 20.7% treated with the vehicle.
Post the announcement of the news, Arcutis’ shares have risen 3.90% at market close. However, the stock has declined 6.3% in the year-to-date period compared with the industry’s fall of 17.7%.
Image Source: Zacks Investment Research
The company intends to report results from an identical pivotal phase III INTEGUMENT-2 study on the candidate by the end of 2022. If all goes well, Arcutis will submit a supplemental new drug application (sNDA) in 2023 for roflumilast 0.15% for mild to moderate AD in individuals six years or older.
Arcutis is also evaluating the candidate in a third pivotal phase III study, INTEGUMENT-PED, in patients aged two to five years old.
We remind investors that Arcutis launched roflumilast cream 0.3% in August 2022, under the trade name Zoryve, after the FDA approved it in July to treat plaque psoriasis in the intertriginous areas in individuals 12 years of age or older.
The company is also developing a topical foam formulation of roflumilast and has completed pivotal phase III studies in seborrheic dermatitis and scalp and body psoriasis.
Immunocore’s loss per share estimates for 2022 have narrowed from $1.25 to 97 cents over the past 30 days. The loss per share for 2023 has narrowed from $1.69 to $1.10 in the same time frame.
Earnings of Immunocore beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion. The average earnings surprise for IMCR is 68.34%.
AVEO Pharmaceuticals loss per share estimates for 2022 have narrowed down from 94 cents to 68 cents over the past 30 days. The earnings estimate for 2023 remained steady at improved from 41 cents to 52 cents in the same time frame.
Earnings of AVEO beat estimates in three of the trailing four quarters, while missing the same in the reaming occasion. The average earnings surprise for AVEO is 19.87%.
Eton Pharmaceuticals’ loss per share estimates for 2022 remained steady at 44 cents in the past 30 days. The earnings per share for 2023 have remained steady at a cent in the same time frame.
Earnings of Eton missed estimates in three of the trailing four quarters, while beating the same on the remaining occasion. The average earnings surprise for ETON is 115.63%.
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Arcutis (ARQT) Up on Top-Line Data From Atopic Dermatitis Study
Arcutis Biotherapeutics (ARQT - Free Report) recently announced top-line data from its phase III INTEGUMENT-1 pivotal study of roflumilast cream 0.15% to treat mild to moderate atopic dermatitis (AD) in adults and children more than six years.
Roflumilast, the company’s lead candidate, is a non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor.
Atopic dermatitis is a chronic skin disease characterized by itchy and inflamed skin, common mainly in children. Per the company, the disease needs rapid-acting topical treatment options since the available treatment with corticosteroids causes major side effects.
The INTEGUMENT-1 study met its primary endpoint, with 32% of the individuals treated with roflumilast cream 0.15% achieving Investigator Global Assessment (IGA) Success - AD score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline, at week four compared with 15.2% of the subjects treated with a vehicle. The ointment was also well tolerated by the subjects.
The study achieved all its secondary endpoints. 43.2% of the subjects treated with the roflumilast 0.15% cream achieved a 75% reduction in Eczema Area and Severity Index (EASI) at week four compared with 22% treated with vehicle.
The study also measured the reduction in itchiness in children 12 years and older. Of the subjects, 33.6% treated with the candidate achieved a four-point reduction in Itch Numeric Scale (WI-NRS) at week four compared with 20.7% treated with the vehicle.
Post the announcement of the news, Arcutis’ shares have risen 3.90% at market close. However, the stock has declined 6.3% in the year-to-date period compared with the industry’s fall of 17.7%.
Image Source: Zacks Investment Research
The company intends to report results from an identical pivotal phase III INTEGUMENT-2 study on the candidate by the end of 2022. If all goes well, Arcutis will submit a supplemental new drug application (sNDA) in 2023 for roflumilast 0.15% for mild to moderate AD in individuals six years or older.
Arcutis is also evaluating the candidate in a third pivotal phase III study, INTEGUMENT-PED, in patients aged two to five years old.
We remind investors that Arcutis launched roflumilast cream 0.3% in August 2022, under the trade name Zoryve, after the FDA approved it in July to treat plaque psoriasis in the intertriginous areas in individuals 12 years of age or older.
The company is also developing a topical foam formulation of roflumilast and has completed pivotal phase III studies in seborrheic dermatitis and scalp and body psoriasis.
Arcutis Biotherapeutics, Inc. Price
Arcutis Biotherapeutics, Inc. price | Arcutis Biotherapeutics, Inc. Quote
Zacks Rank and Stock to Consider
Arcutis currently holds a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same sector includes Immunocore (IMCR - Free Report) , carrying a Zacks Rank #1 (Strong Buy) and AVEO Pharmaceuticals and Eton Pharmaceuticals (ETON - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Immunocore’s loss per share estimates for 2022 have narrowed from $1.25 to 97 cents over the past 30 days. The loss per share for 2023 has narrowed from $1.69 to $1.10 in the same time frame.
Earnings of Immunocore beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion. The average earnings surprise for IMCR is 68.34%.
AVEO Pharmaceuticals loss per share estimates for 2022 have narrowed down from 94 cents to 68 cents over the past 30 days. The earnings estimate for 2023 remained steady at improved from 41 cents to 52 cents in the same time frame.
Earnings of AVEO beat estimates in three of the trailing four quarters, while missing the same in the reaming occasion. The average earnings surprise for AVEO is 19.87%.
Eton Pharmaceuticals’ loss per share estimates for 2022 remained steady at 44 cents in the past 30 days. The earnings per share for 2023 have remained steady at a cent in the same time frame.
Earnings of Eton missed estimates in three of the trailing four quarters, while beating the same on the remaining occasion. The average earnings surprise for ETON is 115.63%.