Arcutis Biotherapeutics ( ARQT Quick Quote ARQT - Free Report) 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. Image Source: Zacks Investment Research
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.
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 Quick Quote ANIK - Free Report) , Annovis Bio ( ANVS Quick Quote ANVS - Free Report) and Corcept Therapeutics ( CORT Quick Quote CORT - Free Report) , 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 .
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