Arcutis BiotherapeuticsNASDAQ: ARQT

Arcutis Biotherapeutics (ARQT) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

ZORYVE foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved in Canada in over two decades1 Second approval of ZORYVE outside of the United States, expanding ZORYVE portfolio availability to over 2 million Canadians living with seborrheic dermatitis WESTLAKE VILLAGE, Calif., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that its wholly-owned subsidiary Arcutis Canada, Inc. has received regulatory approval from Health Canada for ZORYVE (roflumilast) topical foam 0.3% for the treatment of seborrheic dermatitis in patients 9 years of age and older.

ZORYVE demonstrated consistent efficacy in disease clearance and reduction in itch for individuals with atopic dermatitis (AD) regardless of race, ethnicity, and Fitzpatrick skin type ZORYVE was safe and well tolerated across all subgroups Data presented at the 2024 European Academy of Dermatology & Venereology Congress WESTLAKE VILLAGE, Calif., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology and immunology, today announced new pooled subgroup analysis results from the Phase 3 INTEGUMENT-1 and -2 trials showing that ZORYVE cream 0.15% provided consistent and meaningful improvements in signs and symptoms of AD in individuals regardless of race, ethnicity, and Fitzpatrick skin types.

U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025 Almost half of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp Supplemental New Drug Application (sNDA) supported by positive efficacy and safety data from Phase 2b and pivotal Phase 3 trials, and long-term ZORYVE cream plaque psoriasis program WESTLAKE VILLAGE, Calif., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis.

Arcutis Biotherapeutics, Inc. is a biotech company based in California that markets two dermatological products, ZORYVE cream and foam, containing roflumilast, a PDE4 inhibitor. Despite initial struggles post-IPO, Arcutis has seen a significant increase in revenues and a narrowing of losses in Q2 2024, with new product approvals and collaborations. Analysts predict strong growth potential for ZORYVE, but competition in the dermatological market poses a challenge for Arcutis to maintain and grow market share.

Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT ) Q2 2024 Earnings Conference Call August 14, 2024 4:30 PM ET Company Participants Latha Vairavan - VP, Finance and Head of IR Frank Watanabe - President & CEO Todd Edwards - Chief Commercial Officer Patrick Burnett - Chief Medical Officer David Topper - CFO Conference Call Participants Vikram Purohit - Morgan Stanley Tyler Van Buren - TD Cowen Seamus Fernandez - Guggenheim Securities Uy Ear - Mizuho Securities Serge Belanger - Needham Chris Shibutani - Goldman Sachs Operator Hello, and thank you for standing by. Welcome to Arcutis Biotherapeutics Q2 2024 Earnings Call.

Arcutis Biotherapeutics, Inc. (ARQT) came out with a quarterly loss of $0.42 per share versus the Zacks Consensus Estimate of a loss of $0.48. This compares to loss of $1.16 per share a year ago.

Arcutis Biotherapeutics (ARQT) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Over 200-person sales force to promote ZORYVE (roflumilast) in primary care and pediatric practices Provides access to a large portion of the 7.4 million individuals treated for plaque psoriasis, seborrheic dermatitis, and atopic dermatitis outside of dermatology offices ZORYVE will be promoted in the primary position to maximize prescriber education WESTLAKE VILLAGE, Calif. and MONTGOMERY, Ala.