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Arcutis (ARQT) Stock Rises 31% in the Past Month: Here's Why
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Arcutis Biotherapeutics (ARQT - Free Report) rallied 30.9% in the past month after the FDA approved the supplemental new drug application (sNDA) for its marketed product, Zoryve (roflumilast) cream 0.15%, to treat mild to moderate atopic dermatitis (AD) in adult and pediatric patients aged six years and older.
AD, also known as eczema, is a chronic skin disease characterized by itchy and inflamed skin, primarily common in children. Per Arcutis, 9.6 million children and 16.5 million adults in the United States are affected by AD.
Please note that Zoryve cream 0.15% is a once-daily, next-gen topical PDE4 inhibitor that has demonstrated rapid, significant and sustained reduction in itch, the most bothersome symptom of AD, as soon as 24 hours following the first application in clinical studies.
The latest FDA approval was primarily based on positive data from two identical phase III studies, INTEGUMENT-1 and INTEGUMENT-2, that evaluated the safety and efficacy of Zoryve cream 0.15% for four weeks in 1,337 adults and children suffering from AD.
Both studies achieved the primary and key secondary endpoints, with significant improvements observed as early as week 1. Additionally, the drug was overall well-tolerated in both studies and adverse events related to treatment were mostly mild to moderate in severity.
Arcutis plans to make Zoryve cream 0.15% widely available through key wholesalers and dermatology pharmacies by the end of July, ensuring predictable access with a simple copay and fulfillment process. The company also has several patient assistance initiatives to help financially eligible uninsured or underinsured AD patients access the drug.
Management believes that the sNDA approval brings a new steroid-free treatment option for AD without some of the risks associated with stand-of-care topical steroid treatment, thereby addressing a huge unmet medical need.
Year to date, shares of Arcutis have skyrocketed 230.3% against the industry’s 2.7% decline.
Image Source: Zacks Investment Research
The approval of Zoryve cream 0.15% for the AD indication marks the third FDA approval of a commercial product for Arcutis in just the last two years. A 0.3% formulation of the cream was initially approved and subsequently launched in 2022 for the topical treatment of plaque psoriasis in patients aged 12 years and above.
Last year, the FDA expanded the drug’s label to include the treatment of patients in the age group of 6-11 years for the psoriasis indication. Psoriasis is a common, non-contagious skin condition affecting around nine million people in the United States.
In 2023, the FDA approved Arcutis’ NDA for Zoryve topical foam 0.3% for the treatment of seborrheic dermatitis in patients aged nine years and above.
Following the nod, Arcutis’ Zoryve foam became the first drug approved by the FDA to treat seborrheic dermatitis with a new mechanism of action in over two decades.
Zoryve has witnessed strong uptake since launch fueled by continued growth of unit demand. In the first quarter of 2024, Arcutis recorded $15 million from the sales of Zoryve cream 0.3%, representing growth of 675% over the year-ago quarter. Revenues generated from the sale of Zoryve topical foam 0.3% was $6.5 million, which represented sequential growth of 59%.
The company is simultaneously evaluating roflumilast cream for AD at a lower dose of 0.05% for children aged two to five years. Arcutis has also completed the clinical development program for Zoryve foam 0.3% to treat scalp and body psoriasis. It plans to submit an sNDA for the drug for this additional indication in the third quarter of 2024. Potential approvals will further boost revenues.
In the past 60 days, estimates for ANI Pharmaceuticals 2024 earnings per share (EPS) have improved from $4.41 to $4.44. EPS estimates for 2025 have improved from $4.85 to $5.42. Year to date, shares of ANIP have jumped 16.5%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 53.90%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2024 loss per share have narrowed from $1.30 to $1.29, while loss per share estimates for 2025 have narrowed from $1.08 to $1.02. Year to date, shares of ADPT have lost 9.2%.
ADPT’s earnings beat estimates in two of the trailing four quarters, meeting the same once and missing on the remaining occasion, the average surprise being 0.65%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $2.94 to $2.93. Loss per share estimates for 2025 have narrowed from $2.06 to $2.05. Year to date, shares of RAPT have plunged 84.9%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.
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Arcutis (ARQT) Stock Rises 31% in the Past Month: Here's Why
Arcutis Biotherapeutics (ARQT - Free Report) rallied 30.9% in the past month after the FDA approved the supplemental new drug application (sNDA) for its marketed product, Zoryve (roflumilast) cream 0.15%, to treat mild to moderate atopic dermatitis (AD) in adult and pediatric patients aged six years and older.
AD, also known as eczema, is a chronic skin disease characterized by itchy and inflamed skin, primarily common in children. Per Arcutis, 9.6 million children and 16.5 million adults in the United States are affected by AD.
Please note that Zoryve cream 0.15% is a once-daily, next-gen topical PDE4 inhibitor that has demonstrated rapid, significant and sustained reduction in itch, the most bothersome symptom of AD, as soon as 24 hours following the first application in clinical studies.
The latest FDA approval was primarily based on positive data from two identical phase III studies, INTEGUMENT-1 and INTEGUMENT-2, that evaluated the safety and efficacy of Zoryve cream 0.15% for four weeks in 1,337 adults and children suffering from AD.
Both studies achieved the primary and key secondary endpoints, with significant improvements observed as early as week 1. Additionally, the drug was overall well-tolerated in both studies and adverse events related to treatment were mostly mild to moderate in severity.
Arcutis plans to make Zoryve cream 0.15% widely available through key wholesalers and dermatology pharmacies by the end of July, ensuring predictable access with a simple copay and fulfillment process. The company also has several patient assistance initiatives to help financially eligible uninsured or underinsured AD patients access the drug.
Management believes that the sNDA approval brings a new steroid-free treatment option for AD without some of the risks associated with stand-of-care topical steroid treatment, thereby addressing a huge unmet medical need.
Year to date, shares of Arcutis have skyrocketed 230.3% against the industry’s 2.7% decline.
Image Source: Zacks Investment Research
The approval of Zoryve cream 0.15% for the AD indication marks the third FDA approval of a commercial product for Arcutis in just the last two years. A 0.3% formulation of the cream was initially approved and subsequently launched in 2022 for the topical treatment of plaque psoriasis in patients aged 12 years and above.
Last year, the FDA expanded the drug’s label to include the treatment of patients in the age group of 6-11 years for the psoriasis indication. Psoriasis is a common, non-contagious skin condition affecting around nine million people in the United States.
In 2023, the FDA approved Arcutis’ NDA for Zoryve topical foam 0.3% for the treatment of seborrheic dermatitis in patients aged nine years and above.
Following the nod, Arcutis’ Zoryve foam became the first drug approved by the FDA to treat seborrheic dermatitis with a new mechanism of action in over two decades.
Zoryve has witnessed strong uptake since launch fueled by continued growth of unit demand. In the first quarter of 2024, Arcutis recorded $15 million from the sales of Zoryve cream 0.3%, representing growth of 675% over the year-ago quarter. Revenues generated from the sale of Zoryve topical foam 0.3% was $6.5 million, which represented sequential growth of 59%.
The company is simultaneously evaluating roflumilast cream for AD at a lower dose of 0.05% for children aged two to five years. Arcutis has also completed the clinical development program for Zoryve foam 0.3% to treat scalp and body psoriasis. It plans to submit an sNDA for the drug for this additional indication in the third quarter of 2024. Potential approvals will further boost revenues.
Arcutis Biotherapeutics, Inc. Price and Consensus
Arcutis Biotherapeutics, Inc. price-consensus-chart | Arcutis Biotherapeutics, Inc. Quote
Zacks Rank & Other Stocks to Consider
Arcutis currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Adaptive Biotechnologies Corporation (ADPT - Free Report) and RAPT Therapeutics, Inc. (RAPT - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals 2024 earnings per share (EPS) have improved from $4.41 to $4.44. EPS estimates for 2025 have improved from $4.85 to $5.42. Year to date, shares of ANIP have jumped 16.5%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 53.90%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2024 loss per share have narrowed from $1.30 to $1.29, while loss per share estimates for 2025 have narrowed from $1.08 to $1.02. Year to date, shares of ADPT have lost 9.2%.
ADPT’s earnings beat estimates in two of the trailing four quarters, meeting the same once and missing on the remaining occasion, the average surprise being 0.65%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $2.94 to $2.93. Loss per share estimates for 2025 have narrowed from $2.06 to $2.05. Year to date, shares of RAPT have plunged 84.9%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.