NEKTAR THERAPEUTICS 8-K

What Happened

• On February 10, 2026 Nektar Therapeutics announced results from the 36‑week blinded maintenance period (weeks 16–52) of its global Phase 2b REZOLVE‑AD study of rezpegaldesleukin in 393 patients with moderate‑to‑severe atopic dermatitis. Patients were randomized for a 16‑week induction and responders (EASI‑50 at week 16) were re‑randomized 1:1 to continue maintenance dosing every 4 weeks (Q4W) or every 12 weeks (Q12W). The 24 µg/kg Q4W and Q12W regimens showed the highest maintenance of response at Week 52, with gains in deep responses (EASI‑100) over the maintenance period.

Key Details

• Trial size and design: 393 patients enrolled; induction randomization 3:3:3:2; maintenance re‑randomization 1:1 among responders after 16 weeks.
• EASI‑100 (complete skin clearance) gains among all re‑randomized patients: Q4W increased from 4% to 22%; Q12W from 9% to 18% (week 16 → week 52).
• For re‑randomized patients who had achieved EASI‑75 or vIGA‑AD response at maintenance baseline: Q4W EASI‑100 rose from 6% to 30%; Q12W from 14% to 27%.
• Week 52 maintenance snapshot (24 µg/kg pooled): Q4W (N=55) — EASI‑75 71%, EASI‑90 80%, vIGA‑AD 0/1 85%, Itch NRS response 75%; Q12W (N=56) — EASI‑75 83%, EASI‑90 78%, vIGA‑AD 0/1 63%, Itch NRS 77%.
• Safety: no new safety signals in maintenance/escape periods; discontinuation for adverse events 3.5% overall. TEAEs: 72% (re‑randomized rezpegaldesleukin), 65% (placebo in maintenance), 83% (escape patients). Injection site reactions were most common and mostly mild (77%).
• Regulatory plans: following an End of Phase 2 meeting with FDA, Nektar and FDA aligned on evaluating a 24 µg/kg Q2W induction for 24 weeks with co‑primary endpoints (EASI‑75 and an IGA endpoint) in two planned Phase 3 registrational trials; Phase 3 will include a 36‑week maintenance assessing 24 µg/kg Q4W and Q12W. Phase 3 start planned Q2 2026.

Why It Matters

• The results show sustained disease control with continued rezpegaldesleukin treatment and indicate some patients achieve deeper responses (EASI‑100) over extended therapy — data that Nektar will use to design Phase 3 trials. Safety in maintenance was consistent with earlier data and had low discontinuation due to adverse events. For investors, the filing signals clinical progress, planned Phase 3 timelines (Q2 2026 start) and regulatory alignment with the FDA, all key milestones for rezpegaldesleukin’s development path.