May 15th 2025
Scott Batty, MD, and Chris VanDeusen, PhD, provided insights on AX-158's phase 2a results, presented at the SID Annual Meeting.
May 9th 2025
The promising safety and efficacy results were presented at the Society for Investigative Dermatology 2025 Annual Meeting.
May 8th 2025
Selective ITK inhibition with oral soquelitinib led to early and durable clinical responses, cytokine reduction, and increased T regulatory cells.
April 29th 2025
The FDA approved pz-cel, a groundbreaking gene therapy for recessive dystrophic epidermolysis bullosa, transforming treatment options for patients.
April 18th 2025
Dupilumab becomes the first targeted therapy approved for chronic spontaneous urticaria in more than a decade.
FDA Grants Investigational New Drug Clearance for Ensemble No.2 for Phase 1 Atopic Dermatitis Trial
Ensemble No.2, or ENS-002, is an investigational live biotherapeutic product first detected by Concerto Biosciences using its kChip technology.
Health Canada Authorizes Lebrikizumab for Moderate to Severe Atopic Dermatitis in Patients 12 Years and Older
Authorization for Eli Lilly's Ebglyss is based on positive results from the ADvocate 1, ADvocate 2, and ADhere studies.
FDA Approves Sofpironium (Sofdra) as First and Only Chemical Entity for Primary Axillary Hyperhidrosis
Botanix Pharmaceuticals announced the approval of its sofpironium topical gel, 12.45% for adults and children ages 9 and older.
SFA-002 Shows Promise in Early Clinical Trial Psoriasis Cohorts
Stefan Weiss, MD, MBA, explains next steps for the oral treatment after the completion of phase 1b enrollment.
FDA Approves Tralokinumab Autoinjector for Adults With Moderate to Severe Atopic Dermatitis
LEO Pharma's Adbry, a single-dose autoinjector, is expected to become available to patients in the coming months.
Late-Breaker: Roflumilast Cream 0.15% Demonstrates Continued Improvement in AD Symptoms Through 56 Weeks
Roflumilast cream 0.15% is being evaluated for patients with mild to moderate atopic dermatitis down to 6 years.
SDPA Poster Reports Positive Phase 3 Results of Dupilumab for PN
Researchers found dupilumab improved itch and skin lesions regardless of atopic disease status in patients with PN.
VYNE Therapeutics Initiates Phase 2b Trial of BET Inhibitor VYN201 for Vitiligo
The primary efficacy endpoint is the proportion of subjects achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index.
Moderna and Merck Announce New 3-Year Data for mRNA-4157 Combined With Pembrolizumab for High-Risk Stage III/IV Melanoma
Phase 3 trials have been initiated in patients with high-risk melanoma.
Soterios Announces New Positive Topline Results of STS-01 for Alopecia Areata
The phase 2 study achieved the primary end point of a >30% Severity of Alopecia Tool score improvement.
May Pipeline Roundup
The month of May has been full of pipeline news, including updates on VYN201 for nonsegmental vitiligo, imsidolimab for GPP, sonelokimab for HS, and more.
Results of Phase 3 BE HEARD Trials of Bimekizumab for HS Published in The Lancet
The Lancet data is the primary publication of bimekizumab results from BE HEARD I and BE HEARD II.
FDA Updates PDUFA Date of Subcutaneous Nivolumab
The new action date is December 29, 2024.
Baldo Scassellati Sforzolini, MD, PhD, MBA: Expanding Nemolizumab’s Access
Scassellati Sforzolini discusses the significance of Galderma’s nemolizumab receiving 4 additional filing acceptances for prurigo nodularis and atopic dermatitis.
MoonLake’s Sonelokimab Trial for HS Advances to Phase 3
VELA is the first phase 3 hidradenitis suppurativa trial to evaluate HiSCR75 as the primary end point.
Deucravacitinib Demonstrates Sustained Efficacy and Safety in 4-Year Psoriasis Trial
Bristol Myers Squibb announced 70% of patients maintained significant improvement after 4 years with no new safety concerns.
Lindus Health and Acinonyx Bio to Partner in Clinical Trial Evaluating a Benzoyl Peroxide Alternative
Acinonyx Bio's topical cream, ACX, targets Propionibacterium acnes.
Soligenix Announces Publication of Promising Comparative Data for HyBryte Synthetic Hypericin for CTCL
The results are both confirmatory and extend the response results from a prior phase 3 trial known as FLASH.
Merck Halts Dosing of Anti-TIGIT Antibody in KeyVibe-010 Melanoma Study
The analysis revealed a higher rate of discontinuations due to immune-mediated adverse experiences.
AnaptysBio Announces Positive Topline Results from Phase 3 Trial of Imsidolimab for GPP
Patients who responded to imsidolimab in GEMINI-1 and who moved into GEMINI-2 maintained clear or almost clear skin.
VYNE Therapeutics Provides Updates on VYN201 for Nonsegmental Vitiligo and VYN202 for Inflammatory Diseases
VYNE expects to enroll the first patient with vitiligo in the phase 2b trial for VYN201 in the second quarter of 2024.
ASLAN Expands Collaboration with Zenyaku to Investigate Eblasakimab’s MOA Compared to Other Biologics in AD
The new research will compare eblasakimab to dupilumab and lebrikizumab.
Eli Lilly Resubmits BLA for Lebrikizumab for the Treatment of Moderate to Severe AD
A decision from the FDA is expected in the second half of 2024.
FDA Accepts Dermavant’s sNDA for Tapinarof Cream 1% for Adults and Children With AD
The FDA’s PDUFA date is expected in quarter 4 of 2024.
Upadacitinib Outperforms Dupilumab in Primary and Secondary End Points in Head-to-Head AD Study
In LEVEL-UP, upadacitinib demonstrated superiority over dupilumab in achieving EASI-90 and little to no itch at week 16.
ASLAN Announces Positive Phase 2 Results of Eblasakimab in Dupilumab-Treated Patients With AD
Sixty percent of dupilumab-treated patients with AD treated with 400mg of eblasakimab weekly achieved EASI-90 after 16 weeks.
MoonLake Immunotherapeutics and Komodo Health to Partner to Improve Research on Inflammatory Skin Conditions
MoonLake’s sonelokimab is being evaluated for hidradenitis suppurativa, psoriasis, and psoriatic arthritis.
Apremilast Demonstrates Consistent Safety and Efficacy in Children with Moderate to Severe Plaque Psoriasis at 52 Weeks
Loretta Fiorillo, MD, FRCPC, reviews key data points from the phase 3 SPROUT study.
Pelthos Therapeutics Launches to Accelerate Commercialization of Treatment for Molluscum Contagiosum
The new launch is set to bring berdazimer topical gel, 10.3% to adults and pediatric patients over the age of 1 with molluscum contagiosum faster.
ARCA Biopharma and Oruka Therapeutics Agree to Merger
The merger will focus on advancing Oruka’s portfolio of novel biologics for the treatment of chronic skin diseases.