Arcutis Biotherapeutics

2024 saw over 25 pediatric FDA approvals, including givinostat for Duchenne muscular dystrophy, FluMist for influenza, clonidine hydrochloride for ADHD, dupilumab for eosinophilic esophagitis, epinephrine nasal spray for anaphylaxis, and roflumilast cream for atopic dermatitis.

Arcutis Biotherapeutics submitted an sNDA to the FDA for roflumilast cream 0.05% (ZORYVE) for mild to moderate atopic dermatitis in children aged 2-5. The topical PDE4 inhibitor demonstrated consistent, rapid relief and was well-tolerated in pivotal trials. If approved, it could advance care for young AD patients.

Arcutis Biotherapeutics submitted an sNDA to the FDA for roflumilast cream 0.05% (Zoryve) for mild to moderate atopic dermatitis in children aged 2-5. The submission is supported by phase 3 INTEGUMENT-PED trial results showing rapid itch reduction and disease clearance, and a well-tolerated safety profile. If approved, it could offer a new topical option for young AD patients.

Arcutis Biotherapeutics granted 44,000 restricted stock units to six new employees, vesting over four years, as per Nasdaq Listing Rule 5635(c)(4).

Roflumilast cream 0.15% showed high efficacy in treating mild to moderate atopic dermatitis in patients aged 6 years and older, with more patients achieving a validated IGA-AD score of 0/1 and minimal application site irritation.

Arcutis Biotherapeutics reports Q3 2024 net product revenues of $44.8M for ZORYVE® franchise, with 45% growth QoQ. ZORYVE foam sNDA accepted by FDA for scalp and body psoriasis, PDUFA date May 22, 2025. Health Canada approves ZORYVE foam for seborrheic dermatitis, planned launch by end of 2024.

Global exosome market to grow at ~20% CAGR by 2030, driven by chronic disease incidence, diagnostic improvements, and personalized medicine interest. North America leads, with key players like Danaher and Thermo Fisher Scientific. Notable developments include Aruna Bio's US patent for neural exosomes and EXO Biologics' EUR 16 million Series A funding.

Roflumilast foam 0.3% shows significant DLQI score improvement in seborrheic dermatitis by Week 2, maintained through Week 8, per STRATUM trial findings presented at the Fall Clinical Dermatology Conference.

Arcutis Canada received Health Canada approval for ZORYVE foam to treat seborrheic dermatitis in patients aged nine and above, based on positive Phase III STRATUM trial results. ZORYVE foam offers rapid itch relief and is the first topical treatment with a new mechanism of action for seborrheic dermatitis in Canada in over two decades.

The FDA approved roflumilast cream 0.15% for mild-to-moderate atopic dermatitis in patients aged 6 years and older, based on clinical trials showing efficacy and safety. Eric Simpson discusses the benefits of this non-steroidal topical treatment, highlighting its rapid itch reduction and favorable safety profile, making it a reliable option for pediatricians.