Arcutis (ARQT) Files sNDA for Zoryve in Atopic Dermatitis, Stock Up
Arcutis Biotherapeutics ARQT announced that it submitted a supplemental new drug application (sNDA) to the FDA, seeking expanded approval for its roflumilast cream 0.15% to treat patients aged 6 year and older with atopic dermatitis, also called “eczema”. Following this announcement, shares of the company were up 5.1% on Sep 12.
Roflumilast cream is approved in the United States under the brand name Zoryve to treat plaque psoriasis in patients aged 12 years and older. The company launched Zoryve in August 2022, and since then, the drug has experienced robust demand growth, with more than 70,000 prescriptions filled by 7,500 unique prescribers.
Shares of Arcutis have nosedived 44.6% year to date compared with the industry’s 12.8% decline.
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The sNDA seeking approval for expanded use of Zoryve for eczema is based on positive data from two phase III studies — INTEGUMENT-1 and INTEGUMENT-2.Both the studies met their primary endpoint of Investigator Global Assessment (IGA) Success at Week 4 by demonstrating statistically significant improvements over vehicle. The studies also met their secondary endpoints, including a rapid reduction in itchiness.
Atopic dermatitis is a chronic skin disease characterized by itchy and inflamed skin, primarily common in children. Per the company, the disease needs rapid-acting topical treatment options since the available treatment with corticosteroids causes major side effects.
Arcutis also filed a separate sNDA seeking label expansion of Zoryve to treat kids (aged two years and older) with plaque psoriasis. In the fourth quarter of 2023, management anticipates a potential approval for Zoryve for treating plaque psoriasis in children. The successful approval of roflumilast cream for additional indications will likely drive Arcutis' top-line growth.
Arcutis Biotherapeutics, Inc. Price and Consensus
Arcutis Biotherapeutics, Inc. price-consensus-chart | Arcutis Biotherapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Arcutis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same industry are Anika Therapeutics ANIK, Annovis Bio ANVS and Corcept Therapeutics CORT, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate forAnika Therapeutics has narrowed from a loss of $1.41 per share to a loss of $1.32 for 2023. The bottom-line estimate has narrowed from a loss of 79 cents to a loss of 64 cents for 2024 during the same time frame. Shares of the company have lost 42.4% year to date.
ANIK’s earnings beat estimates in one of the trailing four quarters and missed the mark in the remaining three, delivering an average negative surprise of 32.12%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to a loss of $2.77 for 2024 during the same time frame. Shares of the company have lost 17% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 62.6% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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