Arcutis (ARQT) Up in FDA Nod for Zoryve in Seborrheic Dermatitis

Arcutis Biotherapeutics, Inc. ARQT announced that the FDA has approved a new drug application (NDA) for Zoryve (roflumilast) topical foam 0.3% for the treatment of seborrheic dermatitis in patients nine years of age and older. The company’s shares rose 4.1% on December 18, following the news announcement on December 15.

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

Following the latest nod, Zoryve foam is now the first drug approved by the FDA to treat seborrheic dermatitis with a new mechanism of action in more than two decades. Arcutis plans to launch Zoryve foam in the United States by the end of January 2024.

The above approval is based on positive data from two studies the STRATUM and the phase II (Trial 203) study.

Data from the STRATUM study showed that approximately 80% of individuals treated with Zoryve foam 0.3% achieved an Investigator Global Assessment (IGA) success rate at week 8 compared to 58% in the vehicle arm , and thus the primary endpoint was reached. Treatment with Zoryve foam also led to statistically significant improvements in the vehicle arm in all secondary endpoints, including itching, scaling and erythema (redness) in the STRATUM study.

Meanwhile, in the phase II (Trial 203) study, 73% of individuals treated with Zoryve foam achieved IGA success compared to 40.8% in the vehicle arm.

Following the latest FDA nod for Zoryve foam in seborrheic dermatitis, the company plans to submit a supplemental new drug application (sNDA) seeking approval for Zoryve foam to treat scalp and body psoriasis.

Arcutis shares have fallen 82.1% over the past year compared to an industry decline of 18.3%.

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The Zoryve cream formulation is approved in the United States for the treatment of plaque psoriasis in patients 12 years of age and older. The FDA approved the sNDA for Zoryve cream 0.3% to treat patients in the age group of 6-11 years suffering from plaque psoriasis in October 2023.

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

Another sNDA seeking to expand the label of roflumilast cream 0.15% to treat patients aged six years and older with atopic dermatitis is currently being evaluated in the United States. A decision from the FDA is expected on Jul 07, 2024.

Zacks Rank and Other Stocks to Consider

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

Some other top stocks in the healthcare sector are Journey Medical Corporation DERM, Entrada Therapeutics, Inc. TRDA and Puma Biotechnology, Inc. PBYI, each has a Zacks Rank #1 (Strong Buy). You see the complete list of Zacks #1 Rank stocks today here.

Over the past 60 days, estimates for Journey Medicals 2023 loss per share have narrowed from $1.28 to 16 cents. Meanwhile, loss per share estimates for 2024 narrowed from 41 cents to 35 cents. Over the past year, DERM shares have risen 533.6%.

Journey Medical’s earnings beat estimates in one of the last four quarters while missing both on the remaining three occasions. DERM delivered a four-quarter earnings surprise of 118.25%, on average.

Over the past 60 days, estimates for Entrada Therapeutics 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 narrowed from $2.35 to $2.04. Over the past year, TRDA shares have dropped 8.9%.

Entrada Therapeutics’ earnings beat estimates in three of the last four quarters while missing both on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.

Over the past 60 days, estimates for Puma Biotechnology 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 rose from 55 cents to 64 cents. Over the past year, PBYI shares have lost 22.2%.

Puma Biotechnology’s earnings have beaten estimates in three of the last four quarters while missing both on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.

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