Clinical-stage biotechnology company Nektar Therapeutics (Nasdaq: NKTR) announced on Tuesday that the US Food and Drug Administration (FDA) has granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very severe alopecia areata (AA) in adults and paediatric patients 12 years of age and older who weigh at least 40 kilograms.

Rezpegaldesleukin is an investigational biologic therapy that targets the interleukin-2 receptor complex in the body to stimulate proliferation of inhibitory immune cells known as regulatory T cells (Tregs). According to Nektar, results from multiple clinical trials have shown that rezpegaldesleukin safely and dose-dependently increased Tregs.

The FDA's Fast Track process is intended to ensure that important new treatments reach patients as quickly as possible. The designation is granted to investigational therapies that treat serious conditions and have the potential to address an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent meetings and written interactions with the FDA to discuss the drug candidate's development plan as well as possible eligibility for rolling review and priority review.

The REZOLVE-AA study enrolled approximately 90 patients with severe-to-very severe alopecia areata who have not previously been treated with a JAK inhibitor or other biologic. Patients were randomised across two different dose regimens of rezpegaldesleukin or placebo. The company expects to release trial results in December 2025.