Nektar gets FDA fast track designation

Nektar gets FDA fast track designation

SAN FRANCISCO, July 02, 2025 — Nektar Therapeutics (Nasdaq: NKTR) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rezpegaldesleukin, an investigational biologic therapy, for the treatment of severe-to-very severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms. The Fast Track designation aims to expedite the review and approval of promising new treatments for serious conditions [1].

Rezpegaldesleukin targets the interleukin-2 receptor complex to stimulate the proliferation of regulatory T cells (Tregs), which are powerful inhibitory immune cells. The drug has shown safe and dose-dependent increases in Tregs in multiple clinical trials. Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Research & Development Officer at Nektar, expressed satisfaction with the designation, highlighting the urgent need for novel treatments for alopecia areata [1].

The REZOLVE-AA Phase 2b study, initiated in March 2024, enrolled approximately 90 patients with severe-to-very severe alopecia areata. The 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 these results in December 2025 [1].

Alopecia areata is a chronic, systemic, immune-mediated inflammatory disease that affects approximately 6.7 million people in the U.S. and 160 million worldwide. Current treatments are not durable and have high relapse rates, creating an urgent unmet medical need for more effective therapies [1].

Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for autoimmune and chronic inflammatory diseases. Rezpegaldesleukin is one of the company's lead product candidates, being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and one in alopecia areata [1].

The Fast Track designation allows for more frequent interactions with the FDA and potential eligibility for rolling review and priority review. This designation does not guarantee approval but aims to expedite the process for promising treatments [1].

References:
[1] Nektar Therapeutics. (2025). Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Severe-to-Very Severe Alopecia Areata. Retrieved from https://ir.nektar.com/news-releases/news-release-details/nektar-therapeutics-receives-fast-track-designation-0