Noticias y eventos de Nektar Therapeutics (NKTR)NKTRNektar Therapeutics

Nektar Publishes REZOLVE-AD Study Data

Nektar announced the publication of peer-reviewed data from the 16-week induction period of REZOLVE-AD, a global, randomized, double-blind, placebo-controlled Phase 2b study evaluating rezpegaldesleukin in adults with moderate-to-severe atopic dermatitis, or AD. The publication in The Lancet provides the full reporting of efficacy, safety, pharmacodynamics, pharmacokinetics, and biomarker findings from the 16-week induction period of the Phase 2b trial. All three dosing regimens met the primary endpoint: Patients treated with rezpegaldesleukin showed statistically significant, dose-dependent improvement in mean percent reduction in EASI from baseline at Week 16. Key secondary endpoints were met: significant improvements over placebo were observed, all favoring rezpegaldesleukin 24 undefined/kg q2w. Safety data for rezpegaldesleukin for the 16-week induction period were consistent with the previously observed and reported safety profile. Serious adverse events were rare, 2%, with no deaths reported during the 16-week induction period and no increased risk of infections, conjunctivitis, or other safety signals associated with currently approved AD therapies. The 24 undefined/kg q2w induction dosing and monthly and quarterly maintenance dosing regimens have been selected for the ZENITH AD Phase 3 program, which is currently enrolling.

Nektar Reports Q2 Revenue of $10.1M, Below Consensus

Reports Q2 revenue $10.1M, consensus $10.47M. "This year continues to be a transformative year for Nektar as we advance our lead program, rezpegaldesleukin, into Phase 3 clinical trials," said CEO Howard Robin. "We initiated the first Phase 3 ZENITH AD trials in atopic dermatitis in July, and we plan to start a single registrational Phase 3 study in alopecia areata in early 2027. Our Phase 3 program establishes a clear path to the first BLA submission for rezpegaldesleukin in 2029. With its novel T-reg mechanism, rezpegaldesleukin is uniquely positioned to provide benefit for patients across a number of chronic autoimmune conditions. Importantly, our financial position is strong with over $1B in cash and investments at the end of the quarter, and a cash runway that extends into 3Q28, past the initial Phase 3 data readouts expected in mid-2028."

Nektar Initiates Global Registrational Trials for Rezpegaldesleukin

Nektar announced the initiation of the first two global registrational trials in the Phase 3 ZENITH AD program for rezpegaldesleukin. The ZENITH AD program is evaluating rezpegaldesleukin in patients who are 12 years of age or older with moderate-to-severe atopic dermatitis. The program includes three global trials: ZENITH AD-1 and ZENITH AD-2 will enroll biologic and systemic JAK inhibitor treatment-naive patients and ZENITH AD-3 will enroll patients with prior systemic biologic and/or JAK inhibitor treatment experience. Rezpegaldesleukin is a first-in-class regulatory T-cell biologic designed to address imbalances in the immune system that underlie many autoimmune disorders and chronic inflammatory conditions. The ZENITH AD program and the Phase 3 registrational trial in alopecia areata were designed following completion of End-of-Phase 2 meetings with the FDA and scientific advice from the European Medicines Agency and are intended to support both U.S. and European registration in both indications.