Arcutis Biotherapeutics, Inc. - ARQT STOCK NEWS

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.

Arcutis Biotherapeutics announced the publication of positive results from two pivotal Phase 3 trials (INTEGUMENT-1 and -2) for ZORYVE® (roflumilast) cream 0.15% in the Journal of American Medical Association Dermatology. The trials evaluated the efficacy and safety of ZORYVE cream as a once-daily, steroid-free treatment for mild to moderate atopic dermatitis (AD) in adults and children aged 6 and older.

Key findings include:

• 31% of patients achieved Investigator Global Assessment Success at Week 4 vs 14% for vehicle
• Rapid improvement in itch within 24 hours of first application
• Over 30% achieved Worst Itch-Numeric Rating Scale Success at Week 4
• More than 40% achieved a 75% reduction in Eczema Area and Severity Index score at Week 4
• ZORYVE cream demonstrated a favorable safety and tolerability profile

Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company specializing in immuno-dermatology innovations, has granted 37,000 restricted stock units to three newly hired employees. The Compensation Committee approved these awards under the company's 2022 Inducement Plan, with a grant date of September 3, 2024. This action complies with Nasdaq Listing Rule 5635(c)(4), serving as an inducement for new employees joining Arcutis.

The restricted stock units have a four-year vesting schedule, with 25% vesting on each annual anniversary of the vesting commencement date. Vesting is contingent upon continuous employment with Arcutis. This disclosure aligns with Nasdaq Listing Rule 5635(c)(4) requirements.

Arcutis Biotherapeutics (Nasdaq: ARQT) has completed enrollment for its Phase 1b study of ARQ-255, a topical JAK1 inhibitor for alopecia areata. The study, involving 44 participants, aims to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of ARQ-255 in healthy adults and those with patchy alopecia areata. ARQ-255 utilizes Arcutis' proprietary Deep Dermal Drug Delivery (4D) technology to target inflammation at the hair follicle base. This innovation addresses a significant unmet need, as alopecia areata affects approximately 1 in 500 people with no FDA-approved topical treatments currently available. Results from this first-in-human study are expected in the first half of 2025, potentially advancing treatment options for this immune-mediated skin condition.

Arcutis Biotherapeutics (NASDAQ: ARQT) announced positive long-term results for roflumilast cream 0.05% in treating mild to moderate atopic dermatitis in children aged 2 to 5. The INTEGUMENT-OLE study showed durable efficacy and a favorable safety profile over 56 weeks of treatment. Key findings include:

- 71.9% of participants achieved EASI-75 after 56 weeks
- 53.8% achieved vIGA-AD success at 56 weeks
- No new safety signals observed
- Low incidence of adverse events, mostly mild to moderate

Arcutis plans to submit a supplemental New Drug Application (sNDA) to the FDA in Q1 2025 for roflumilast cream 0.05% for AD treatment in children aged 2-5 years.

Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company specializing in immuno-dermatology innovations, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The company's management will engage in a fireside chat on Thursday, September 5, 2024, at 1:50 pm ET.

Interested parties can access the webcast through the 'Events' section of Arcutis' website. A replay of the presentation will remain available on the company's website for 180 days following the conference, providing extended access to investors and stakeholders unable to attend the live event.

Arcutis Biotherapeutics (ARQT) reported strong Q2 2024 financial results, with net product revenues of $30.9M for the ZORYVE® franchise, showing a 547% increase year-over-year and 43% quarter-over-quarter growth. The company saw improved gross-to-net (GTN) performance, now in the high 50% range.

Key highlights include:

• Entered a co-promotion agreement with Kowa Pharmaceuticals America to expand ZORYVE's reach
• Submitted an sNDA for ZORYVE foam for scalp and body psoriasis
• Amended $200M term-loan for better financial flexibility
• Launched ZORYVE cream for atopic dermatitis in late July

Arcutis reported a net loss of $52.3M for Q2 2024, with cash and equivalents of $363.1M as of June 30, 2024. The company continues to focus on commercial growth and pipeline development in immuno-dermatology.

Arcutis Biotherapeutics reported strong Q2 2024 financial results, with net product revenues of $30.9M for the ZORYVE franchise, representing a 547% increase year-over-year and 43% growth quarter-over-quarter. The company saw improved gross-to-net (GTN) margins, now in the high 50% range. Arcutis entered a co-promotion agreement with Kowa Pharmaceuticals to expand ZORYVE's reach in primary care and pediatric offices. They also submitted an sNDA for ZORYVE foam for scalp and body psoriasis treatment. The company amended its $200M term-loan, improving financial flexibility. Despite strong sales growth, Arcutis reported a net loss of $52.3M for Q2 2024, with cash and equivalents of $363.1M as of June 30, 2024.

Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on immuno-dermatology innovations, has reported the grant of 38,000 restricted stock units to four newly hired employees. The awards were approved by the Compensation Committee of Arcutis' Board of Directors under the company's 2022 Inducement Plan, with a grant date of August 1, 2024.

These stock units are designed as an inducement for new employees joining Arcutis, in compliance with Nasdaq Listing Rule 5635(c)(4). The restricted stock units have a four-year vesting schedule, with 25% vesting on each annual anniversary of the vesting commencement date, contingent on continuous employment with Arcutis.