WESTLAKE VILLAGE, Calif. - Arcutis Biotherapeutics, Inc. (NASDAQ: NASDAQ:ARQT), a biopharmaceutical company, has submitted a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam to the U.S. Food and Drug Administration (FDA) for the treatment of scalp and body psoriasis in adults and adolescents aged 12 and older.
This submission follows positive results from the ARRECTOR Phase 3 trial and a Phase 2b study, demonstrating significant improvement in scalp and body psoriasis.
Clinical trials showed that 67% of participants achieved Scalp-Investigator Global Assessment (S-IGA) success with ZORYVE foam at 8 weeks, and a rapid reduction in scalp itch was observed as soon as 24 hours after the first application.
Moreover, 46.5% of participants achieved Body-Investigator Global Assessment (B-IGA) success at 8 weeks. These results indicate that ZORYVE foam could be a promising new treatment option for the nearly 40% of the 9 million Americans with plaque psoriasis who suffer from scalp involvement.
Roflumilast foam, a phosphodiesterase-4 (PDE4) inhibitor, is designed for easy application on hair-bearing areas, which are typically challenging to treat with creams or ointments. The safety profile of ZORYVE foam was favorable, with the most common adverse reactions being headache, diarrhea, nausea, and nasopharyngitis, and low rates of discontinuation due to adverse events.
The company's president and CEO, Frank Watanabe, emphasized the potential of ZORYVE foam to become a new standard of care for multiple immune-mediated, chronic skin diseases, citing its rapid adoption in treating seborrheic dermatitis. The company also acknowledged the contributions of clinical investigators, study coordinators, patients, and caregivers who participated in the trials.
ZORYVE foam is already approved for the treatment of seborrheic dermatitis in patients 9 years and older, and ZORYVE cream is approved for plaque psoriasis and atopic dermatitis in patients 6 years and older. The latest sNDA seeks to expand its use to scalp and body psoriasis, addressing a significant need for steroid-free treatment options that can be applied to hair-bearing areas.
This news is based on a press release statement from Arcutis Biotherapeutics, Inc. and has been reported without the inclusion of subjective assessment or promotional language. The submission to the FDA represents a step forward in the potential expansion of treatment options for individuals with scalp and body psoriasis.
In other recent news, Arcutis Biotherapeutics has reported substantial growth in Q1 2024, with net revenues reaching $21.6 million, a 59% increase from the previous quarter. This financial performance is primarily attributed to the success of the company's Zoryve product lineup, which generated over 255,000 prescriptions from more than 12,500 unique prescribers. Moreover, Arcutis raised $172 million in a secondary offering and entered into a licensing agreement with Sato Pharmaceutical.
Mizuho Securities maintained its Outperform rating on Arcutis Biotherapeutics and increased the price target to $19.00, reflecting a positive outlook on the company's Zoryve product sales.
The firm anticipates the Zoryve franchise to report approximately $31 million in sales for Q2 2024, surpassing the market expectations of around $28 million. The company's management also expects a modest quarter-over-quarter improvement in gross-to-net figures.
Arcutis is awaiting the FDA's final decision on its supplemental New Drug Application for roflumilast cream 0.15% intended for the treatment of atopic dermatitis. Mizuho Securities expressed optimism about the FDA approval of the application.
Arcutis received positive feedback for its Zoryve foam for seborrheic dermatitis and plans to expand indications for scalp and body psoriasis. These are among the recent developments highlighting Arcutis Biotherapeutics' strong position in the dermatology treatments market.
InvestingPro Insights
Arcutis Biotherapeutics, Inc. (ARQT) has recently made headlines with its submission of a supplemental New Drug Application for ZORYVE foam. As the company navigates the regulatory landscape, investors and stakeholders are closely watching its financial health and market potential. Here are some key insights drawn from InvestingPro data and tips that may provide a broader context to the company's current standing and future outlook.
InvestingPro Data highlights a robust revenue growth for ARQT, with a staggering 1545.18% increase in the last twelve months as of Q1 2024. This is complemented by an even higher quarterly revenue growth of 1682.42% in Q1 2024. Such figures suggest that the company is rapidly expanding its sales, which could be further bolstered by the potential FDA approval of ZORYVE foam for additional indications.
Furthermore, the gross profit margin stands at an impressive 92.99%, indicating that ARQT is able to retain a significant portion of its revenue after accounting for the costs of goods sold. This metric is particularly relevant, as it showcases the company's efficiency in managing its production and distribution costs, which is crucial for its long-term profitability.
Still, with a market cap of approximately 1140M USD and a negative P/E ratio of -3.76, it's clear that investors are still cautious about the company's profitability. The adjusted P/E ratio for the last twelve months as of Q1 2024 is even lower at -5.24, reflecting the market's concerns about the company's earnings relative to its share price.
Among the InvestingPro Tips, it's noteworthy that analysts do not anticipate the company will be profitable this year, which aligns with the negative P/E ratios observed. Nevertheless, the fact that ARQT holds more cash than debt on its balance sheet is a positive sign, indicating a solid liquidity position that could support its operations and investments in the near term.
Moreover, three analysts have revised their earnings upwards for the upcoming period, suggesting a potential shift in the company's financial trajectory that investors may want to consider. With a fair value estimate of 19 USD by analysts and an InvestingPro fair value of 11.47 USD, there seems to be a divergence in valuation perspectives, presenting an opportunity for investors to delve deeper into the company's fundamentals and market prospects.
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For further details and to explore a total of 12 InvestingPro Tips for ARQT, visit: https://www.investing.com/pro/ARQT. These tips could help inform investment decisions by providing a deeper understanding of the company's operational strengths and weaknesses, as well as market expectations.
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