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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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Inside the Apogee Pipeline: Company Shares Updates on APG777 and APG990 for AD

The Dermatology Digest

Apogee Therapeutics recently hosted its first R&D Day, which featured updates across its entire portfolio. Some of the key highlights related to atopic dermatitis (AD) therapies include: APG777 APG777 is a novel, subcutaneous, extended half-life monoclonal antibody (mAb) targeting interleukin (IL)-13.

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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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