Arcutis Biotherapeutics

DelveInsight's 2025 Psoriasis Pipeline Report reveals over 80 companies developing 80+ pipeline therapies, highlighting significant R&D investment in this therapeutic area.

• The FDA is reviewing Dupixent for chronic spontaneous urticaria, with a PDUFA date of April 18, 2025, potentially offering a novel targeted therapy after a decade of limited options. • Abeona Therapeutics' pz-cel for recessive dystrophic epidermolysis bullosa has a resubmitted BLA with a PDUFA date of April 29, 2025, following a Complete Response Letter earlier in 2024. • Arcutis Biotherapeutics' roflumilast foam for scalp and body psoriasis has a PDUFA date of May 22, 2025, offering a steroid-free alternative for hard-to-treat areas.

• Dupilumab (Dupixent) gains FDA approval as the first treatment specifically for children aged 1-11 with eosinophilic esophagitis, addressing a critical unmet need for this age group. • Epinephrine nasal spray (Neffy) is approved as the first nasal spray for anaphylaxis treatment in adults and children over 66 lbs, offering a needle-free alternative for emergency use. • Roflumilast cream 0.15% (Zoryve) receives FDA approval for mild to moderate atopic dermatitis in patients aged 6 and older, providing a new nonsteroidal option.

Arcutis Biotherapeutics has submitted an sNDA to the FDA for roflumilast cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2 to 5 years.

• Roflumilast cream 0.15% demonstrated significantly higher efficacy than the vehicle in achieving a validated IGA-AD score of 0/1 in patients with atopic dermatitis. • The study found that over 95% of patients treated with roflumilast cream reported no signs of application site irritation, highlighting its tolerability. • Roflumilast significantly improved EASI 75 scores compared to the vehicle, indicating a substantial reduction in eczema severity among treated patients. • This once-daily, nonsteroidal cream addresses key unmet needs in atopic dermatitis treatment, potentially improving patient adherence and outcomes.

• Arcutis Biotherapeutics' ZORYVE franchise achieved $44.8 million in net product revenues in Q3 2024, marking a 452% increase compared to Q3 2023, driven by strong demand for both cream and foam formulations. • The FDA accepted the sNDA for ZORYVE foam for scalp and body psoriasis, with a PDUFA action date of May 22, 2025, potentially expanding the drug's approved indications. • Health Canada approved ZORYVE foam for seborrheic dermatitis, with commercial launch planned by the end of 2024, extending the drug's availability to international markets. • Arcutis is advancing its pipeline with the completion of enrollment in the ARQ-255 alopecia areata phase 1 trial and progress towards an IND for ARQ-234 in atopic dermatitis.

• Roflumilast foam 0.3% significantly improved Dermatology Life Quality Index (DLQI) scores in seborrheic dermatitis patients as early as Week 2, compared to the vehicle. • The STRATUM phase 3 trial data showed that roflumilast foam maintained these improvements through 8 weeks of treatment, indicating a sustained benefit. • Patients using roflumilast foam were significantly more likely to achieve a clinically meaningful improvement in DLQI scores compared to those using the vehicle. • Roflumilast foam 0.3% significantly increased the odds of patients achieving a DLQI score of 0 or 1, indicating minimal impact on quality of life.

• Health Canada has approved Arcutis Biotherapeutics' ZORYVE (roflumilast) topical foam 0.3% for treating seborrheic dermatitis in patients aged nine years and older. • The approval was based on the Phase III STRATUM study, where 80% of patients achieved treatment success by week eight using ZORYVE foam. • ZORYVE foam offers a novel mechanism of action and provides significant itch relief within 48 hours, marking a new advancement in seborrheic dermatitis treatment. • This marks the second international approval for ZORYVE, offering a steroid-free option for over two million Canadians affected by this chronic skin condition.

• The FDA approved roflumilast cream 0.15% (Zoryve) for mild-to-moderate atopic dermatitis (AD) in patients aged 6 years and older. • Clinical trials (INTEGUMENT-1 and INTEGUMENT-2) demonstrated the efficacy and safety of roflumilast 0.15% compared to vehicle in over 1300 adults and children. • Roflumilast cream 0.15% significantly improved itch and other AD symptoms, with improvements observed as early as Week 1. • Pediatricians can confidently prescribe roflumilast cream 0.15% as a once-daily, steroid-free topical treatment for AD, with referral to a dermatologist for non-responsive cases.

• Bimzelx gains FDA approval for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis, marking it as the first IL-17A/F inhibitor for four immune-mediated diseases. • Arcutis' Zoryve foam sNDA accepted by the FDA for scalp and body psoriasis, supported by phase 2b and 3 data showing symptom improvement and safety, with a target action date set for May 2025. • Semaglutide shows potential in reducing flare-ups and improving quality of life for hidradenitis suppurativa patients, suggesting weight loss medications could complement existing treatments.