ivarmacitinib topical suspension (ARQ-255) / Arcutis - LARVOL DELTA

Arcutis Announces Second Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Other Pipeline Updates: Following the evaluation of results from the Phase 1b trial of ARQ-255, a penetrating topical formulation of ivarmacitinib for the treatment of alopecia areata, the Company has elected to halt further development of this program. While clinical and biomarker results indicated some level of efficacy, the results did not meet the Company's threshold for advancement, and the Company has deprioritized the program given other R&D priorities across its portfolio."

Discontinued • Alopecia

Arcutis Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "ZORYVE cream: The Company aims to obtain Medicaid coverage in additional states, as well as some Medicare coverage, during 2025....The Company submitted an sNDA for ZORYVE cream 0.05% to the FDA for the treatment of atopic dermatitis in children ages 2 to 5 with an anticipated target action date in Q4 of 2025, if accepted as submitted....ZORYVE foam...which was accepted by the FDA in September with a PDUFA action date set for May 22, 2025....ARQ-255...the Company announced that it completed enrollment in a Phase 1b study evaluating ARQ-255 for the treatment of alopecia areata, with data expected in H1 2025....ARQ-234...being developed as a potential biologic treatment in atopic dermatitis....The Company has continued preclinical development efforts and is working towards submitting an Investigational New Drug application in 2025."

Enrollment closed • IND • P1 data • PDUFA • Reimbursement • Alopecia • Atopic Dermatitis • Psoriasis

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Ivarmacitinib (SHR0302) in Adult Patients with Moderate to Severe Alopecia Areata. (PubMed, J Am Acad Dermatol) - "Treatment with ivarmacitinib 4 mg and 8 mg doses in moderate and severe AA patients for 24 weeks was efficacious and generally tolerated."

Clinical • Journal • P2 data • Alopecia • Follicular Lymphoma • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • CD8 • JAK1