Nektar Therapeutics disclosed that its Phase 2b REZOLVE‑AA study of rezpegaldesleukin (REZPEG) in 92 patients with severe‑to‑very‑severe alopecia areata produced a 28.2 % mean reduction in the Severity of Alopecia Tool (SALT) score at week 36 in the 24 µg/kg arm and a 30.3 % reduction in the 18 µg/kg arm, compared with an 11.2 % reduction in the placebo group. When four patients with major eligibility violations were excluded, the 24 µg/kg and 18 µg/kg arms achieved 29.6 % and 30.4 % reductions, respectively, versus 5.7 % in placebo, with p‑values of 0.049 and 0.042, indicating statistical significance for both doses.
The dose‑dependent clinical effect and the statistical significance achieved after excluding ineligible patients provide a compelling proof‑of‑concept for rezpegaldesleukin. The study also showed that treatment arms separated from placebo at all time points and that secondary endpoints—SALT ≤ 30, SALT ≤ 20, and SALT ≤ 10—were met in a dose‑responsive manner, underscoring the drug’s potential to deliver meaningful hair regrowth in a population with limited therapeutic options.
Nektar’s financial backdrop highlights the strategic importance of these clinical results. In the fourth quarter of 2024, the company generated $29.2 million in revenue, up from $23.9 million in the same period a year earlier, and reported $98.4 million in full‑year revenue, a rise from $90.1 million in 2023. Despite these revenue gains, Nektar continues to post net losses and a high cash burn rate, with cash and marketable securities projected to sustain operations through the fourth quarter of 2026. The positive trial data therefore represent a critical step toward a potential Phase 3 program that could improve the company’s long‑term financial trajectory.
Management emphasized the significance of the findings. CEO Howard W. Robin said the company plans to advance rezpegaldesleukin into a Phase 3 program for alopecia areata in 2026, leveraging the drug’s Fast Track designation. Dermatology experts, including Dr. Jonathan Silverberg and Dr. David Rosmarin, highlighted the drug’s ability to stimulate regulatory T‑cells and produce meaningful hair regrowth, including eyebrow and eyelash growth, in patients with severe disease.
The market reaction to the announcement was muted, reflecting a mix of optimism about the clinical data and concern over Nektar’s cash burn and insider selling. While the trial results support a strong case for future development, investors remain cautious about the company’s ability to translate clinical success into sustainable revenue growth in the face of ongoing financial headwinds.
Nektar’s strategy to extend rezpegaldesleukin into other autoimmune indications—such as atopic dermatitis and type 1 diabetes—further positions the drug as a platform candidate. The positive alopecia areata data strengthen the case for a broader therapeutic portfolio, but the company must navigate the competitive landscape of JAK inhibitors and other emerging biologics while managing its cash position and maintaining investor confidence.
Nektar’s next steps include submitting the full Phase 2b data at a 2026 medical conference and releasing additional data from a 16‑week extension in early Q2 2026. The company’s ability to secure regulatory approval and achieve commercial success will hinge on demonstrating consistent efficacy, a favorable safety profile, and a clear pathway to market in a disease area with significant unmet need.
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