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Nektar’s Alopecia Drug Misses Phase 2b Goal as Company Cites Ineligible Patients, Plans Phase 3

Nektar points to eligibility violations inflating the placebo response as it charts a Phase 3 path.

Overview

  • Topline modified intent-to-treat analysis showed mean SALT score reductions at Week 36 of 28.2% and 30.3% for rezpegaldesleukin versus 11.2% for placebo, with p-values of 0.186 and 0.121.
  • When four patients with major eligibility violations were excluded, placebo performance fell to 5.7% and the two dose arms reached about 29.6% and 30.4%, with p-values of approximately 0.049 and 0.042.
  • The REZOLVE-AA Phase 2b trial enrolled 92 patients with severe-to-very-severe alopecia areata.
  • Safety was consistent with prior studies, with mostly mild or moderate adverse events, a 1.4% discontinuation rate, and no observed increase in major cardiovascular events.
  • Nektar plans to begin Phase 3 testing next year, investors sent shares down roughly 7% to 8% on Tuesday, and the company expects extension results in early Q2 2026 with a full data presentation targeted for 2026.