Arcutis Biotherapeutics
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2016-01-06
- Employees
- 296
- Market Cap
- $1.2B
- Website
- http://www.arcutis.com
- Introduction
Arcutis Biotherapeutics, Inc. engages in the development and commercialization of treatments for dermatological diseases. Its pipeline consists of topical treatments for plaque psoriasis, atopic dermatitis, hand eczema, vitiligo, scalp psoriasis, alopecia areata, and seborrheic dermatitis. The company was founded by Bhaskar Chaudhuri and David W. Osborne in June 2016 and is headquartered in Westlake Village, CA.
Robust Pipeline of 80+ Therapies Advancing in Psoriasis Treatment Landscape
• DelveInsight's 2025 Psoriasis Pipeline Report reveals over 80 companies developing 80+ pipeline therapies, highlighting significant R&D investment in this therapeutic area.
• Promising treatments in development include topical roflumilast (Arcutis Biotherapeutics) in Phase III trials and GSK2982772 (GlaxoSmithKline), a novel RIPK1 inhibitor in Phase I development.
• Alumis Inc. has initiated a long-term extension study for ESK-001 in moderate to severe plaque psoriasis patients, evaluating safety, efficacy, and durability of response over 24 weeks.
JAK Inhibitors Pipeline Expands with 55+ Drug Candidates as Major Pharma Companies Drive Innovation
• The JAK inhibitors therapeutic landscape shows robust growth with over 50 pharmaceutical companies developing 55+ pipeline candidates across various clinical stages.
• Key drug candidates including Povorcitinib, Zasocitinib, and Ritlecitinib are advancing through late-stage clinical trials for conditions like vitiligo, psoriasis, and ulcerative colitis.
• Recent developments include promising results from Pelabresib-ruxolitinib combination therapy for myelofibrosis and expanded access initiatives by Eli Lilly for baricitinib in Africa.
FDA Accepts Review of UZEDY for Bipolar I Disorder Treatment Extension
• Teva and Medincell announce FDA acceptance of supplemental New Drug Application for UZEDY as a maintenance treatment for bipolar I disorder in adults, expanding from its current schizophrenia indication.
• The application leverages existing UZEDY clinical data and previous FDA findings on risperidone formulations for bipolar I disorder, potentially offering a new long-acting injectable treatment option.
• If approved, UZEDY would address medication adherence challenges in bipolar I disorder, which affects over 3.4 million U.S. adults and causes significant mood and behavioral disruptions.
Novel Oral Psoriasis Therapies Show Promise: TYK2 Inhibitors Lead Breakthrough Advances
• Deucravacitinib demonstrates superior efficacy over apremilast in psoriasis treatment, with over 53% of patients achieving significant skin clearance at week 16.
• Apremilast maintains its position as a key therapy for mild-to-moderate psoriasis, with 21% of bio-naïve patients achieving treatment goals in the ADVANCE trial.
• Next-generation oral therapies, including JNJ-77242114 and zasocitinib, show promising results in clinical trials, potentially expanding treatment options for psoriasis patients.
FDA Delays Review of SUBLOCADE Label Changes for Opioid Use Disorder Treatment
• Indivior PLC reports FDA has delayed final review of proposed label changes for SUBLOCADE, their extended-release buprenorphine injection for opioid use disorder treatment.
• The proposed modifications include updates for rapid initiation protocol and alternative injection sites, with the original PDUFA date set for February 7, 2025.
• FDA has confirmed acceptance of the proposed label with no outstanding items to address, though final approval timeline remains pending.
Advancements in Acute Lymphocytic Leukemia (ALL) Treatment Landscape
• The FDA approved obecabtagene autoleucel (Aucatzyl) for adults with relapsed or refractory B-cell precursor ALL, marking a significant advancement in CAR T-cell therapy.
• A pivotal clinical trial revealed transformative findings poised to change the standard of care for children with acute lymphoblastic leukemia (ALL), marking a milestone in pediatric oncology.
• Pfizer's BESPONSA received FDA approval for pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell ALL, expanding treatment options for this population.
FDA Anticipated to Decide on Dupixent, Pz-cel, and Roflumilast Foam for Dermatologic Conditions by Mid-2025
• 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.
FDA Approves Novel Therapies for Pediatric Conditions: Eosinophilic Esophagitis, Anaphylaxis, and Atopic Dermatitis
• 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 Seeks FDA Approval for Roflumilast Cream in Young Children with Atopic Dermatitis
• 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.
• The sNDA is supported by data from the INTEGUMENT-PED trial, which showed roflumilast cream significantly improved disease clearance and reduced itch.
• Roflumilast 0.05% cream was well-tolerated in studies, with adverse events consistent with previous trials, offering a potential steroid-free option.
• If approved, roflumilast cream 0.05% could provide a new, effective topical treatment for young children with atopic dermatitis, addressing a significant unmet need.
FDA Approves Organon's Vtama (Tapinarof) Cream for Atopic Dermatitis in Adults and Children
• The FDA has approved Vtama (tapinarof) cream 1% for treating atopic dermatitis in adults and children aged 2 years and older.
• Vtama demonstrated statistically significant improvements in skin clearance and itch reduction compared to the vehicle in clinical trials.
• The treatment offers a steroid-free option with no label warnings, contraindications, or restrictions on treatment duration or body surface area affected.
• Long-term studies showed sustained efficacy and a favorable safety profile, with many patients experiencing extended treatment-free intervals.
FDA Wraps Up 2024 with Key Approvals for Drugs Targeting Various Conditions
• The FDA approved Vertex's Alyftrek for cystic fibrosis, offering improved dosing and potential market exclusivity.
• Novo Nordisk's Alhemo was approved for hemophilia A and B, providing a new option for patients with inhibitors.
• Bristol Myers Squibb's Opdivo Qvantig gained approval as a subcutaneous formulation, offering faster administration for various solid tumors.
• Eli Lilly's Zepbound secured approval for obstructive sleep apnea in obese adults, marking the first prescription medicine for this condition.
Roflumilast Cream Shows High Efficacy in Treating Atopic Dermatitis in Adults and Children
• 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 Reports Strong Q3 2024 Revenue Growth Driven by ZORYVE Franchise
• 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.
Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025
• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
• EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration.
• Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option.
• Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.
Dermatology Advances: Approvals, Trial Results, and New Guidelines Emerge
• The FDA approved bimekizumab for moderate-to-severe hidradenitis suppurativa, marking the first treatment targeting both IL-17A and IL-17F cytokines.
• Subcutaneous nivolumab's PDUFA date was updated, based on Phase 3 data demonstrating noninferiority to intravenous nivolumab in renal cell carcinoma.
• New clinical guidelines emphasize image-guided superficial radiation therapy for nonmelanoma skin cancers, improving precision in treating basal and squamous cell carcinoma.
• Phase 2b trial results show mRNA-4157 combined with pembrolizumab significantly improves recurrence-free survival in high-risk stage III/IV melanoma patients.
Roflumilast Foam Shows Significant Quality of Life Improvements in Seborrheic Dermatitis Patients
• 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 Approves Arcutis' ZORYVE Foam for Seborrheic Dermatitis
• 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.
Roflumilast Cream 0.15% Approved for Pediatric Atopic Dermatitis
• 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.
Dermatology News Roundup: Bimzelx Expansion, Zoryve sNDA, and HS Insights
• 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.
FDA Accepts Roflumilast Foam sNDA for Scalp and Body Psoriasis Treatment
• The FDA has accepted Arcutis Biotherapeutics' sNDA for roflumilast foam 0.3% (Zoryve) for treating scalp and body psoriasis in patients aged 12 and older.
• The acceptance is based on positive results from the ARRECTOR phase 3 trial, a phase 2b study, and long-term data from the Zoryve cream development program.
• Roflumilast foam demonstrated significant improvements in reducing scalp and body itch compared to the vehicle in clinical studies.
• The FDA has set a PDUFA target action date of May 22, 2025, for the decision on the roflumilast foam sNDA.
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