FDA Grants Fast Track Designation to Nektar's Rezpegaldesleukin for Alopecia Treatment

Nektar Therapeutics announced that the FDA granted Fast Track designation for rezpegaldesleukin to treat severe-to-very severe alopecia areata. Clinical trials have shown that rezpegaldesleukin safely and dose-dependently increased regulatory T cells. The company expects to announce topline data in December from its ongoing REZOLVE-AA Phase 2b study and collaborate with the FDA on a potential registrational program. NKTR is trading at $23.55, down 0.42% on the Nasdaq.

Nektar Therapeutics (Nasdaq: NKTR) has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for rezpegaldesleukin, an investigational biologic therapy targeting severe-to-very severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms [1]. The Fast Track designation aims to expedite the development and review of rezpegaldesleukin, which has shown promise in safely and dose-dependently increasing regulatory T cells in clinical trials.

The REZOLVE-AA Phase 2b study, initiated in March 2024, enrolled approximately 90 patients with severe-to-very severe alopecia areata. The study's primary efficacy endpoint will evaluate the mean percent change in the Severity of Alopecia Tool (SALT) score at the end of the 36-week induction period. The company expects to share topline data in December 2025 [1].

Alopecia areata is a chronic, systemic, immune-mediated inflammatory disease with a lifetime incidence of 2% in both men and women. Available therapies for alopecia are not durable and have high relapse rates, creating an urgent unmet medical need for novel, more effective therapies [1].

Nektar Therapeutics, headquartered in San Francisco, California, is focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. The company's lead product candidate, rezpegaldesleukin, is being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and one in alopecia areata [1].

NKTR is trading at $23.55, down 0.42% on the Nasdaq as of July 2, 2025 [1].

References:
[1] https://www.prnewswire.com/news-releases/nektar-therapeutics-receives-fast-track-designation-for-rezpegaldesleukin-for-the-treatment-of-severe-to-very-severe-alopecia-areata-302515436.html