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JNJ Continues to Grow AD Pipeline With New Licensing Agreement

The Dermatology Digest

Johnson & Johnson has entered into an exclusive licensing agreement for the global development, manufacturing and commercialization of a STAT6 program for autoimmune and allergic diseases, including atopic dermatitis (AD), from Kaken Pharmaceutical.

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Done Deal: Organon Completes Acquisition of Dermavant

The Dermatology Digest

Food and Drug Administration (FDA) for treatment of mild, moderate, and severe plaque psoriasis in adults. We are excited to bring this nonbiologic non-steroidal topical option to the millions of patients suffering from a chronic skin condition like plaque psoriasis and, potentially in the future, atopic dermatitis.” “I

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Topline Phase 1 Trial Results for Apogee’s APG777 in AD “Exceed Expectations”

The Dermatology Digest

Pharmacokinetic (PK) data showed a half-life of approximately 75 days across doses tested and pharmacodynamic (PD) data showed, deep and sustained inhibition of key atopic dermatitis (AD) biomarkers pSTAT6 and TARC for ~3 months (longest follow-up available, with inhibition still ongoing at time of the data cut).

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U.S. FDA Accepts sNDA for Arcutis’ Roflumilast Cream 0.05% (Zoryve) for Children Aged 2 to 5 with Mild-to-moderate AD; PDUFA Date Set

The Dermatology Digest

Food and Drug Administration (FDA) accepted Arcutis Supplemental New Drug Application (sNDA) for roflumilast cream 0.05% (Zoryve) for the treatment of children aged 2 to 5 with mild-to-moderate atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) target action date is set for October 13, 2025. At Week 4, 25.4%

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