A Confluent, Crusty Rash

The company announced completion of target enrollment in the REZOLVE-AA study of rezpegaldesleukin in people with severe-to-very-severe alopecia areata.

The FDA has set a PDUFA target action date for October 13, 2025, according to Arcutis Biotherapeutics.

Investigators reported that roflumilast cream 0.05% significantly reduced AD severity as early as Week 1, with a notable effect on pruritus seen in as little as 24 hours.

Treatment of AD with dupilumab, compared with cyclosporine and methotrexate, was associated with significantly reduced risk of a wide range of CV outcomes at 1 year.

The clearance enables Alphyn to initiate global phase 2b clinical trials, which are anticipated to begin in the first quarter of 2025.

Rezpegaldesleukin targets the IL-2 receptor complex to stimulate regulatory T cells, aiming to restore immune balance in people with atopic dermatitis.