Arcutis Biotherapeutics, Inc. Stock Price, News & Analysis

Arcutis Biotherapeutics' ZORYVE® (roflumilast) cream 0.15% has received Glamour's 2024 Health and Wellness award for Best Eczema Product in the Best Beauty Innovators category. ZORYVE is the first FDA-approved once-daily topical treatment for mild to moderate atopic dermatitis in patients aged 6 and older. The treatment, approved in July 2024, is a next-generation topical PDE4 inhibitor that can be applied anywhere on the body for any duration. Atopic dermatitis, the most common type of eczema, affects approximately 9.6 million children and 16.5 million adults in the United States.

Arcutis Biotherapeutics (ARQT) reported strong Q3 2024 financial results with total product revenues of $44.8 million, representing 452% growth year-over-year and 45% quarter-over-quarter. The revenue breakdown includes $22.0M from ZORYVE cream 0.3%, $20.3M from ZORYVE foam 0.3%, and $2.5M from ZORYVE cream 0.15%. The company improved its gross-to-net ratio to low 50% range and saw a 25% increase in total franchise unit demand. The FDA accepted their sNDA for ZORYVE foam for scalp and body psoriasis with a PDUFA date of May 22, 2025. Health Canada approved ZORYVE foam for seborrheic dermatitis with launch planned by end of 2024.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the grant of equity incentives to five new employees. The compensation package includes 50,000 restricted stock units and options to purchase 50,000 shares of common stock at $8.67 per share. The restricted stock units vest over four years with 25% annual vesting, while stock options vest 25% after one year and the remainder monthly over three years. The grants were approved under the company's 2022 Inducement Plan and comply with Nasdaq Listing Rule 5635(c)(4).

Arcutis Biotherapeutics (ARQT) presented new patient-reported outcome data for ZORYVE® cream 0.15% in treating atopic dermatitis at ACAAI 2024. The Phase 3 INTEGUMENT-1 and -2 trials showed significant improvements across multiple metrics: 64.2% of ZORYVE-treated patients achieved meaningful improvement in SCORAD Total Score vs 36.3% for vehicle at Week 1, and 61.7% showed improvement in POEM scores vs 34.2% for vehicle. The treatment met its primary efficacy endpoint with 31.3% achieving Investigator Global Assessment Success vs 14.1% for vehicle, demonstrating rapid improvement in disease clearance, itch reduction, and quality of life measures for patients and caregivers.

Arcutis Biotherapeutics (ARQT) has scheduled its third quarter 2024 financial results announcement and business update for Wednesday, November 6, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET on the same day. Additionally, Arcutis will participate in Guggenheim's Inaugural Healthcare Innovation Conference with a fireside chat scheduled for Monday, November 11 at 3:30 p.m. ET. Both events will be accessible through webcasts in the 'Events' section of the company's website, with archived replays available afterward.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced that Health Canada has approved ZORYVE® (roflumilast) foam 0.3% for treating seborrheic dermatitis in patients 9 years and older. This marks the first topical treatment with a new mechanism of action approved in Canada in over 20 years for this condition, which affects over 2 million Canadians.

Key points:

• ZORYVE foam is now approved in Canada for seborrheic dermatitis
• It's the second approval of ZORYVE outside the United States
• In clinical trials, about 80% of patients achieved treatment success at Week 8
• Significant itch relief was observed in as little as 48 hours
• The foam is designed to deliver the drug without disrupting the skin barrier

The approval was based on positive results from Phase 3 STRATUM study, a Phase 2 study, a long-term open-label extension study, and a Phase 1 pharmacokinetic study.

Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on immuno-dermatology innovations, has reported the grant of 95,000 restricted stock units and options to purchase 38,000 shares of common stock to 11 newly hired employees. These awards, approved by the Compensation Committee and granted under the company's 2022 Inducement Plan, have a grant date of October 1, 2024.

The restricted stock units vest over four years, with 25% vesting annually. Stock options also vest over four years, with 25% vesting after one year and the remainder in 36 monthly installments. The options have a ten-year term and an exercise price of $9.55 per share, matching Arcutis' closing stock price on October 1, 2024. This disclosure complies with Nasdaq Listing Rule 5635(c)(4).

Arcutis Biotherapeutics (Nasdaq: ARQT) announced new pooled subgroup analysis results from Phase 3 INTEGUMENT-1 and -2 trials for ZORYVE® (roflumilast) cream 0.15% in treating atopic dermatitis (AD). The data, presented at the 2024 European Academy of Dermatology & Venereology Congress, showed consistent efficacy in disease clearance and itch reduction across diverse skin types.

Key findings at Week 4 include:

• Higher percentages of vIGA-AD Success for ZORYVE vs. vehicle across all racial, ethnic, and Fitzpatrick skin type subgroups
• Greater improvement in itch (WI-NRS Success) for ZORYVE-treated patients across all subgroups
• Consistent results for additional endpoints like vIGA-AD score of 'Clear (0)' or 'Almost Clear (1)' and EASI-75

ZORYVE demonstrated a favorable safety profile with low incidence of Treatment Emergent Adverse Events across subgroups.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced that the FDA has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) foam 0.3% for treating scalp and body psoriasis in adults and adolescents ages 12 and over. The FDA set a PDUFA target action date of May 22, 2025.

The sNDA is supported by positive results from the ARRECTOR Phase 3 trial, a Phase 2b study, and long-term data from the ZORYVE cream program. Key findings include:

• 66.4% of patients achieved Scalp-IGA Success with ZORYVE foam vs 27.8% with vehicle
• 45.5% achieved Body-IGA Success vs 20.1% with vehicle
• 65.3% experienced significant itch reduction vs 30.3% with vehicle

ZORYVE foam was well-tolerated with low incidence of adverse events.