Arcutis to Host Investor Conference Call Today to Discuss the FDA Approval of ZORYVE™ (roflumilast) Cream 0.3% for Plaque Psoriasis

Rhea-AI Summary

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced FDA approval for ZORYVE (roflumilast) cream 0.3%, targeting plaque psoriasis treatment in patients aged 12 and older. This approval is significant as it addresses the needs of patients with immune-mediated dermatological conditions. The company aims to leverage its innovative development platform, focusing on unmet patient needs in dermatology. A conference call will discuss the FDA approval details and future plans for commercialization, highlighting Arcutis's commitment to advancing dermatological therapies.

Positive

• FDA approval of ZORYVE expands treatment options for plaque psoriasis patients.
• Market potential for ZORYVE in addressing unmet needs in dermatology.

Negative

• Risks associated with the commercialization of newly approved products may impact market performance.

WESTLAKE VILLAGE, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, will host a conference call for investors today at 8:30 a.m. EDT to discuss the U.S. Food and Drug Administration (FDA) approval of ZORYVE (roflumilast) cream 0.3% for treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Dial-in information for conference participants may be obtained by registering for the event here. A live webcast of the call and presentation material will also be available on the “Events” section of the Company's Investor website. An archived replay of the webcast will be available on the Arcutis website following the call.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including plaque psoriasis, atopic dermatitis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook and Twitter.

Forward-Looking Statements
This press release contains "forward-looking" statements. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, commercialization of newly approved products and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 22, 2022, as amended on March 3, 2022, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts:

Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

FAQ

What is ZORYVE (roflumilast) cream approved for?

ZORYVE is approved for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older.

When was ZORYVE approved by the FDA?

ZORYVE was approved by the FDA on August 1, 2022.

What is the significance of FDA approval for Arcutis Biotherapeutics?

FDA approval enhances Arcutis's product portfolio and market position in the dermatology field, potentially increasing revenue.

What are the potential risks of ZORYVE's commercialization?

Risks include challenges in the commercialization process and competition in the dermatology market.