Nektar Therapeutics announced on July 29, 2025, that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for their investigational biologic therapy, rezpegaldesleukin, aimed at treating severe-to-very severe alopecia areata in adults and children over 12 years old who weigh at least 40 kilograms. Rezpegaldesleukin targets the interleukin-2 receptor complex to promote the proliferation of regulatory T cells, addressing a significant unmet medical need in this chronic, immune-mediated inflammatory disease. This designation allows for more frequent interactions with the FDA and eligibility for accelerated review processes, with Nektar Therapeutics on schedule to release topline data from their Phase 2b study in December.
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