Arcutis (ARQT) receives FDA approval for Zorive in seborrheic dermatitis

Arcutis BioTherapeutics, Inc. ARQT announced that the FDA has approved a New Drug Application (NDA) for Zoriv (roflumilast) Topical Foam 0.3% for the treatment of seborrheic dermatitis in patients nine years of age and older. Following the announcement of the news on December 15, the company’s shares rose 4.1% on December 18.

Seborrheic dermatitis is a skin condition that commonly affects the scalp. Taken once daily, the steroid-free foam Zoryve is effective, safe, and well tolerated for use on all affected areas of the body, including hairy areas.

Following the latest approval, Zoriv Foam is now the first drug to be approved by the FDA for the treatment of seborrheic dermatitis with a new mechanism of action in more than two decades. Arcutis plans to launch Zoriv Foam in the United States by the end of January 2024.

The above approval was based on positive data from two studies Stratum and Phase II (Trial 203) study.

Data from the STRATUM study showed that approximately 80% of individuals treated with Zoriv Foam 0.3% achieved the Investigator Global Assessment (IGA) success rate at Week 8 compared to 58% in the vehicle arm, meeting the primary endpoint. . Treatment with Zorive Foam led to statistically significant improvements in all secondary endpoints on the vehicle arm in the Stratum study, including itching, scaling, and erythema (redness).

Meanwhile, in the Phase II study (Trial 203), 73% of individuals treated with Zoriv Foam achieved IgA breakthrough compared to 40.8% in the vehicle arm.

Following the latest FDA approval for Zoriv Foam in seborrheic dermatitis, the company plans to submit a supplemental new drug application (SNDA) seeking approval for Zoriv Foam for the treatment of scalp and body psoriasis.

Arcutis shares have fallen 82.1% in the past year, compared with the industry’s decline of 18.3%.

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The Zoriv cream formulation is approved in the United States for the treatment of plaque psoriasis in patients aged 12 years and older. The FDA approved the sNDA for Zoriv Cream 0.3% for the treatment of patients aged 6-11 years with plaque psoriasis in October 2023.

In the first nine months of 2023, Arcutis expects to make $15.6 million from sales of the drug.

Another sNDA seeking label extension of roflumilast cream 0.15% for the treatment of patients six years of age and older suffering from atopic dermatitis is currently under review in the United States. The FDA’s decision is expected on July 07, 2024.

Zacks Rank and Other Stocks to Consider

Arcutis currently holds a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the healthcare sector are Journey Medical Corporation Derm, Entrada Therapeutics, Inc. TRDA and PUMA BIOTECHNOLOGY, INC. PBYI, each sporting a Zacks Rank #1 (Strong Buy). you can see Here’s the full list of today’s Zacks #1 Rank stocks,

Over the past 60 days, Journey Medical’s 2023 loss per share estimate has declined from $1.28 to 16 cents. Meanwhile, the loss per share forecast for 2024 has narrowed to 35 cents from 41 cents. Over the past year, shares of DERM have increased by 533.6%.

Journey Medical’s earnings have been better than estimates in one of the last four quarters, while it has been below expectations in the remaining three. DERM delivered an average four-quarter earnings surprise of 118.25%.

Over the past 60 days, Entrada Therapeutics’ 2023 loss per share estimate has declined from $2.07 to 9 cents. Meanwhile, the loss per share forecast for 2024 has dropped to $2.04 from $2.35. TRDA shares have fallen 8.9% in the last year.

Entrada Therapeutics’ earnings beat estimates in three of the last four quarters, while falling short the rest of the way. TRDA delivered a four-quarter average earnings surprise of 70.68%.

Over the past 60 days, Puma Biotechnology’s 2023 earnings per share estimates have increased from 67 cents to 72 cents. Over the same period, earnings per share estimates for 2024 have increased from 55 cents to 64 cents. In the past year, PBYI shares have fallen 22.2%.

Puma Biotechnology’s earnings have beaten estimates in three of the last four quarters while lagging it the rest of the way. PBYI delivered a four-quarter average earnings surprise of 76.55%.

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