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SAN FRANCISCO - The U.S. Food and Drug Administration has granted Fast Track designation for Nektar Therapeutics’ (NASDAQ:NKTR) investigational drug rezpegaldesleukin for treating severe-to-very severe alopecia areata in adults and pediatric patients 12 years and older who weigh at least 40 kilograms. The announcement comes as the $409 million market cap biotech company shows strong momentum, with its stock up 88% over the past six months. According to InvestingPro analysis, the company currently trades near its Fair Value, despite operating challenges including rapid cash burn.
This marks the second Fast Track designation for rezpegaldesleukin, which previously received the same status for atopic dermatitis in February 2025.
The Fast Track process aims to expedite the development of treatments for serious conditions with unmet medical needs. The designation provides Nektar with more frequent FDA interactions and potential eligibility for rolling review and priority review.
Rezpegaldesleukin targets the interleukin-2 receptor complex to stimulate regulatory T cells, which may help rebalance the immune system in autoimmune conditions.
"Alopecia areata is a chronic, systemic, immune-mediated inflammatory disease, and there is an urgent need for novel mechanistic approaches," said Jonathan Zalevsky, Senior Vice President and Chief Research & Development Officer at Nektar.
The company expects to announce topline data in December from its ongoing REZOLVE-AA Phase 2b study, which enrolled approximately 90 patients across 30 sites globally. The trial is evaluating the drug’s efficacy using the Severity of Alopecia Tool (SALT) score. With the next earnings report due on August 7, investors following this development can access comprehensive analysis through InvestingPro’s detailed research reports, which provide deeper insights into Nektar’s financial health and growth prospects among 1,400+ covered US stocks.
Alopecia areata affects approximately 6.7 million people in the U.S. and 160 million worldwide, with about 700,000 Americans currently having some form of the condition.
The information in this article is based on a company press release statement.
In other recent news, Nektar Therapeutics announced the successful pricing of its $100 million public offering of common stock at $23.50 per share. The offering includes 4,255,320 shares, with an option for underwriters to purchase an additional 638,298 shares. This follows the company’s earlier announcement of commencing the public offering, which also includes pre-funded warrants. Meanwhile, Nektar reported significant progress in its clinical trials, as its experimental drug rezpegaldesleukin met primary and key secondary endpoints in a Phase 2b study for moderate-to-severe atopic dermatitis. The study demonstrated statistically significant improvements in the Eczema Area and Severity Score (EASI) across all dosing regimens compared to placebo. These developments come amidst a backdrop of analyst discussions and investor interest. While the stock has experienced fluctuations, the focus remains on Nektar’s clinical advancements and ongoing financial strategies.
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