Arcutis (ARQT) Up on FDA Nod for Zoryve Label Expansion
Arcutis Biotherapeutics ARQT announced that the FDA approved a supplemental new drug application (sNDA), seeking label expansion for Zoryve (roflumilast) cream 0.3% to treat patients in the age group of 6-11 years, suffering fromplaquepsoriasis. Following this announcement, shares of the company were up 5.9% on Oct 06.
Roflumilast cream is approved in the United States under the brand name Zoryve for the tropical treatment of plaque psoriasis in patients aged 12 years and above. Zoryve can be applied once a day and does not contain steroids. The company launched the drug in August 2022, and since then, it has been experiencing robust demand growth. In the first half of 2023, ARQT earned $7.5 million from the sale of the drug.
The sNDA seeking approval for the expanded use of Zoryve is based on positive data from a 4-week Maximal Usage Systemic Exposure study in childrenaged 6-11 years with plaque psoriasis. Data from the study demonstrated that Zoryve's efficacy, safety and tolerability in the specified age group were consistent with the pivotal phase III DERMIS-1 and DERMIS-2 studies conducted in adult patients.
Shares of Arcutis have nosedived 68.3% year to date compared with the industry’s 16.5% decline.
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Psoriasis is a common, non-contagious skin condition affecting around nine million people in the United States. Per the company, the disease needs rapid-acting topical treatment options sincethe same have been limited for children. The condition leads to raised, red skin patches covered with white or silver dead skin cells. These plaques can appear differently in individuals with darker skin tones and may be itchy and painful.
Last month, Arcutis also filed a separate sNDA seeking label expansion of roflumilast cream 0.15% to treat patients aged six years and older with atopic dermatitis, also called “eczema”.
Atopic dermatitis is a chronic skin disease characterized by itchy and inflamed skin, primarily common 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. While Anika Therapeutics currently sports a Zacks Rank #1 (Strong Buy), both Annovis Bio and Corcept Therapeutics carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank 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 $1.24 for 2023. The bottom-line estimate has widened from a loss of 79 cents to a loss of 82 cents for 2024 during the same time frame. Shares of the company have lost 37.6% 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 35.4% 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 30.0% 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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