Dermatology Times June 2025 Recap

Clearances, Approvals, Updates, and Recommendations

Arcutis’ Roflumilast Becomes First FDA-Approved Treatment to Receive the NPF’s Seal of Recognition

The National Psoriasis Foundation Seal of Recognition program has expanded to prescription drugs, making roflumilast the first to achieve the indication.

Alys Pharmaceuticals Submits ALY-301 Clinical Trial Application in Germany for Cold Urticaria

Alys plans to conduct a phase 1/1b trial assessing the efficacy and safety of the mast cell–selective c-Kit inhibitor in the CIndU subtype.

FDA Approves Dupilumab, First and Only Targeted Medicine for Bullous Pemphigoid

Dupilumab gains FDA approval as the first targeted therapy for bullous pemphigoid, offering hope for effective treatment and improved patient outcomes.

Update: FDA Extends Review of Ruxolitinib Cream for Pediatric AD

The new PDUFA date is set for September 2025.

Roflumilast Cream 0.15% for Atopic Dermatitis Receives Strong Recommendation in Updated AAD Guidelines

Arcutis Biotherapeutics' roflumilast cream 0.15% gains strong AAD endorsement for effective AD management in adults and children.

FDA Grants Rare Pediatric Disease Designation to QRX003 for Netherton Syndrome

Quoin Pharmaceuticals advances QRX003 for Netherton syndrome, receiving the FDA's RPD designation and showing promising clinical results.

Big Studies and Big Data

Denifanstat Hits All Targets in Chinese Study

Sagimet Biosciences reveals denifanstat's promising phase 3 results, offering a novel oral treatment for moderate to severe acne with significant efficacy.

Arcutis Presents Long-Term INTEGUMENT-OLE Data on Roflumilast at RAD 2025

Arcutis Biotherapeutics showcases the promising long-term results of roflumilast cream 0.05% (Zoryve).

Barzolvolimab Demonstrates Rapid Symptom Reduction in Chronic Spontaneous Urticaria

The monoclonal anti-KIT antibody exhibited promise in adults with moderate to severe antihistamine-refractory CSU.

Three-Year Data Reveal Long-Term Power of Bimekizumab for PsA

At the 2025 EULAR meeting, UCB presented new 3-year data on bimekizumab for PsA.

Guselkumab Effectively Inhibits Joint Structural Damage in Active PsA

Data presented at EULAR 2025 showcased guselkumab's efficacy as the only IL-23 inhibitor to demonstrate inhibition of this nature in psoriatic arthritis.

German Study Explores the Emotional Impact of Work-Related CHE

A study reveals the significant emotional burden of work-related chronic hand eczema, highlighting the need for tailored psychological support for affected patients.

Both Upadacitinib and Abrocitinib Demonstrate Real-World Efficacy in Patients With AD After 1 Year

A real-world study shows the effectiveness of upadacitinib and abrocitinib for moderate to severe atopic dermatitis after 52 weeks of treatment.

New Phase 3 VIITAL Data Confirm Efficacy of Abeona’s Pz-Cel for RDEB

Abeona Therapeutics' VIITAL trial reveals promising results for RDEB treatment, showcasing significant wound healing and pain relief with pz-cel therapy.

Almirall Shares Real-World Data at 2025 International Congress of Dermatology

Almirall showcased groundbreaking research on atopic dermatitis, psoriasis, and actinic keratosis at the 2025 ICD.

REZOLVE-AD Trial Results Show Promise for Rezpegaldesleukin in Atopic Dermatitis

Nektar Therapeutics reveals positive results from the REZOLVE-AD study, showcasing rezpegaldesleukin's efficacy in treating moderate to severe AD.

Market, Pharma, and Specialty News

INTEGUMENT-INFANT Phase 2 Trial Will Assess Roflumilast in Pediatric Patients With AD

Discover groundbreaking insights from RAD 2025 on roflumilast's potential to transform treatment for infant atopic dermatitis.

Almirall Is First to Apply WHO-5 Well-Being Index in Dermatological Clinical Trial End Points

Almirall is pioneering a holistic approach in dermatology, emphasizing psychological well-being through the WHO-5 index in clinical trials.

Hydrafacial Launches HydraFillic 9-Peptide Booster for Advanced Skin Rejuvenation

Discover the revolutionary Hydrafacial HydraFillic with Pep9 Booster, enhancing skin hydration and reducing fine lines with advanced peptide technology.

Galderma Announces Clinical Trials Evaluating Nemolizumab for SSc and CPUO

Galderma launches clinical trials for nemolizumab, targeting systemic sclerosis and chronic pruritus of unknown origin, addressing critical patient needs.

Strides for Skin Health Equity

SCALE UP Demonstrates AD Symptom Relief Across All Skin Types With Upadacitinib

A poster at RAD 2025 detailed the patient-reported outcomes across skin types and racial groups.

Late-Breaking Data: Lebrikizumab Demonstrates Efficacy in Patients With Skin of Color With AD

At RAD 2025, Eli Lilly revealed promising results for lebrikizumab in treating atopic dermatitis in patients with skin of color.

Late-Breaking Data: Positive Outcomes in Patients With Skin of Color With AD Using Dupilumab

At RAD 2025, the DISCOVER trial showed that dupilumab monotherapy significantly improved moderate to severe AD symptoms in this patient population.

VALIANT Survey Shows High Rates of Depression in Patients With Vitiligo

The VALIANT survey uncovers alarming depression rates in patients with vitiligo, highlighting the urgent need for improved mental health screenings and interventions.

HS Uncovered: Global Survey Highlights Patient Perspectives and Psychosocial Impact

A global survey reveals the significant psychosocial and financial burdens of hidradenitis suppurativa, highlighting the need for improved patient care and treatment options.

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