rezpegaldesleukin (NKTR-358) / Nektar Therapeutics - LARVOL DELTA

Biologic Monotherapies for Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Bayesian Network Meta-Analysis of Established and Investigational Agents. (PubMed, Cureus) - "This Bayesian network meta‑analysis (BNMA) provides the first unified evaluation of all biologic monoclonal antibodies approved as monotherapy for AD (dupilumab, lebrikizumab, tralokinumab) together with emerging immunotherapies, including amlitelimab, rademikibart, rezpegaldesleukin, rocatinlimab, telazorlimab, temtokibart, and zumilokibart, across key efficacy measures.  A PRISMA‑2020-compliant systematic review and PROSPERO‑registered protocol (CRD420251162704) identified phase 2-3 randomized, double‑blind, placebo‑controlled trials reporting week‑16 outcomes (week‑24 for rocatinlimab). Zumilokibart, rademikibart, and temtokibart emerge as additional candidates with encouraging activity, whereas telazorlimab showed limited clinical benefit. Collectively, these findings provide a comprehensive comparative framework to inform biologic selection and therapeutic sequencing."

Journal • Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Novel Regulatory T-cell enhancing Biologic Rezpegaldesleukin: Phase 2b Efficacy and Safety Results Following 36-Weeks of Therapy in Severe-to-Very-Severe Alopecia Areata (AAD 2026) - No abstract available

Clinical • Late-breaking abstract • P2b data • Alopecia • Immunology

Novel Regulatory T-cell enhancing Biologic Rezpegaldesleukin: Phase 2b Efficacy, Safety, and Baseline Severity–Dependent Treatment Response in Moderate-to-Severe Atopic Dermatitis (AAD 2026) - P2 | "Rezpegaldesleukin demonstrated statistically significant improvement in AD severity over the 16-week induction period. These results support further development of rezpegaldesleukin as a novel biologic AD treatment."

Clinical • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL2

Data from Phase 2b Studies for Rezpegaldesleukin Accepted for Two Oral Presentations at the 2026 American Academy of Dermatology Annual Meeting (PRNewswire)

P2b data • Alopecia • Atopic Dermatitis

Dupilumab Outperforms Approved and Investigational Biologic Monotherapies in Moderate-to-Severe Atopic Dermatitis (AAD 2026) - " Seventeen RCTs (n=5508) compared dupilumab, tralokinumab, lebrikizumab, rocatinlimab, amlitelimab and rezpegaldesleukin with placebo at week 16 (rocatinlimab 300mg, 24 weeks). Dupilumab 300mg was the most effective biologic for moderate-to-severe AD, achieving both the strongest relative efficacy and the highest SUCRA ranking. Lebrikizumab emerged as a close second, particularly for itch improvement."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Upcoming Milestones (PRNewswire) - "(i) Data from the 36-week treatment period of the REZOLVE-AA study in patients with alopecia areata were accepted for a presentation in a late-breaking oral session at the...AAD 2026 Annual Meeting...; (ii) Topline data to be reported from the blinded 16-week treatment extension period in the Phase 2b REZOLVE-AA study of rezpegaldesleukin in alopecia areata in April 2026; (iii) Commencement of the Phase 3 studies for rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis in Q2 2026; (iv) Presentation of 36-week maintenance data from the Phase 2b REZOLVE-AD study of rezpegaldesleukin in moderate-to-severe atopic dermatitis at a medical conference in second half of 2026; (v) Topline data to be reported from the 24-week off-treatment period in REZOLVE-AA in Q4 2026; (vi) Topline data to be reported from the 52-week off-treatment period in REZOLVE-AD in Q1 2027."

Late-breaking abstract • New P3 trial • P2b data • Alopecia • Atopic Dermatitis

Nektar Therapeutics…announced the pricing of its upsized underwritten public offering of $400 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants. (PRNewswire) - "Nektar intends to use the net proceeds from the offering for general corporate purposes, which may include research and development, clinical development (including Phase 3 trials for rezpegaldesleukin) and manufacturing costs to support the advancement of its drug candidates, as well as other general corporate purposes."

Financing • Alopecia • Atopic Dermatitis • Type 1 Diabetes Mellitus

New REZOLVE-AD Maintenance Data in Atopic Dermatitis Demonstrate Rezpegaldesleukin Resulted in Durable and New Responses Across Key Disease Measurements with Both Monthly and Quarterly Dosing (PRNewswire) - "71% and 83% of patients maintained EASI-75 responses and 85% and 63% maintained vIGA-AD 0/1 responses with 24 µg/kg monthly and quarterly dosing, respectively. Meaningful improvement in responses observed across key efficacy endpoints at week 52 with both monthly and quarterly dosing, including an up to 5-fold increase in EASI-100 response rates. Favorable safety profile consistent with previously reported results for rezpegaldesleukin. Durability of maintained response rates supports advancement to pivotal Phase 3 program evaluating both monthly and quarterly maintenance dosing....'We look forward to advancing to Phase 3 studies quickly with the goal of submitting a BLA in 2029."

Filing • P2b data • Atopic Dermatitis

Nektar to Hold Conference Call to Discuss Topline Results from the 36-Week Maintenance Period for its REZOLVE-AD Phase 2b Study of Rezpegaldesleukin in Atopic Dermatitis on February 10, 2026 (PRNewswire)

P2b data • Atopic Dermatitis

Early Findings Support Efficacy of Rezpegaldesleukin for AD, Asthma (Dermatology Advisor) - "At week 16, rezpegaldesleukin 24 µg/kg every 2 weeks was associated with significant improvements with respect to mean percent change in EASI (P <.001), EASI 75 (P <.001), EASI 90 (P <.05), vIGA-AD (P <.05), and NRS-Itch (≥4-point improvement; P <.01) scores when compared with placebo. The response was consistent when patients were stratified by disease severity, disease region, and asthma comorbidity."

P2b data • Asthma • Atopic Dermatitis

REZOLVE-AA Phase 2b Study of Rezpegaldesleukin Establishes Proof-of-Concept in Patients with Severe-to-Very-Severe Alopecia Areata (PRNewswire) - "The primary endpoint narrowly missed statistical significance with the mean percent SALT reduction at Week 36 of 28.2% for the 24 µg/kg rezpegaldesleukin arm, 30.3% for the 18 µg/kg rezpegaldesleukin arm, and 11.2% for placebo (p=0.186 and p=0.121, respectively). At all timepoints, the rezpegaldesleukin treatment arms separated from placebo in the study...At Week 36, the mean percent SALT reduction was 29.6% for 24 µg/kg, 30.4% for 18 µg/kg, and 5.7% for placebo (p=0.049 and p=0.042, respectively)....Nektar plans to submit the REZOLVE-AA results for presentation at a medical conference in 2026. Data from the patients ongoing in the 16-week treatment extension will be available in early Q2 2026."

P2b data • Alopecia

Nektar to Hold Conference Call to Discuss Topline Results from the 36-Week Induction Treatment Period for its REZOLVE-AA Phase 2b Study of Rezpegaldesleukin in Alopecia Areata on December 16, 2025 (PRNewswire)

P2b data • Alopecia

Upcoming data readouts include the Phase 2b RESPECT trial for alopecia areata and 52-week maintenance data for atopic dermatitis in early 2026. (Investing.com)

P2b data • Alopecia • Atopic Dermatitis

New Data from REZOLVE-AD Study of Rezpegaldesleukin Presented in Late-Breaking Oral Abstract Presentation at ACAAI 2025 Annual Scientific Meeting (PRNewswire) - "Statistically significant and clinically meaningful improvements in mean ACQ-5 scores were reported at week 16 versus placebo in patients who had atopic dermatitis and a history of asthma. Extended dosing with rezpegaldesleukin q2w supports 24-week induction period for planned Phase 3 studies with improvement across major efficacy endpoints from Week 16 to 24, including EASI-75, EASI-90, and vIGA-AD. Data from long-term maintenance portion of REZOLVE-AD with 52 weeks of treatment expected in Q1 2026 from REZOLVE-AD study."

Late-breaking abstract • P2b data • Atopic Dermatitis

Summary of Financial Results (PRNewswire) - "R&D expense in the third quarter of 2025 was $27.3 million as compared to $35.0 million for the third quarter of 2024....R&D expense decreased in the first nine months of 2025 primarily due to a decrease in expense for the development of NKTR-255, partially offset by an increase in expenses for the development of rezpegaldesleukin and NKTR-0165."

Commercial • Atopic Dermatitis • Immunology • Oncology

Top-line Phase 2b data for rezpegaldesleukin in alopecia areata to be reported in December 2025 (PRNewswire)

P2b data • Alopecia

Rezpegaldesleukin Novel Treg-Inducing therapy Demonstrates Efficacy in Atopic Dermatitis and Asthma in Phase 2b Trial (ACAAI 2025) - P2 | "No new safety signals were observed. Conclusion These findings support further development of rezpegaldesleukin as a novel biologic treatment for AD and asthma."

Clinical • Late-breaking abstract • P2b data • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Respiratory Diseases • IL2

Data from REZOLVE-AD Phase 2b Study for Rezpegaldesleukin Accepted for Late-Breaking Oral Abstract Presentation at ACAAI 2025 Annual Scientific Meeting (PRNewswire)

Late-breaking abstract • P2b data • Atopic Dermatitis

Outcomes Following Discontinuation of Systemic Immunomodulatory Therapies in Adults with Atopic Dermatitis: A Systematic Review (EADV 2025) - "Six studies examined biologic agents (amlitelimab, dupilumab (2 studies), tralokinumab, rezpegaldesleukin, rocatinlimab) and three evaluated JAK inhibitors (baricitinib, abrocitinib, upadacitinib). Emerging evidence suggests that sustaining disease control following discontinuation of systemic immunomodulatory therapy is possible in some adults with AD. Differences in outcomes between therapies may reflect variations in drug mechanisms or study design. To confidently identify individuals who may benefit from treatment discontinuation, further studies are required with harmonised outcomes (e.g."

Clinical • Immunomodulating • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease

Outcomes Following Discontinuation of Systemic Immunomodulatory Therapies in Adults with Atopic Dermatitis: A Systematic Review (EADV 2025) - "Six studies examined biologic agents (amlitelimab, dupilumab (2 studies), tralokinumab, rezpegaldesleukin, rocatinlimab) and three evaluated JAK inhibitors (baricitinib, abrocitinib, upadacitinib). Emerging evidence suggests that sustaining disease control following discontinuation of systemic immunomodulatory therapy is possible in some adults with AD. Differences in outcomes between therapies may reflect variations in drug mechanisms or study design. To confidently identify individuals who may benefit from treatment discontinuation, further studies are required with harmonised outcomes (e.g."

Clinical • Immunomodulating • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease

Efficacy and Safety of Rezpegaldesleukin, A Selective Regulatory T-Cell-Inducing Interleukin-2 Conjugate, in the Treatment of Atopic Dermatitis: Final Results from the 16-Week Induction of a Randomized Phase 2b Study (REZOLVE AD) (EADV 2025) - P2 | "Conclusion In patients with moderate-to-severe AD, treatment with rezpeg showed statistically significant and dose- dependent improvements in physician-assessed and patient-reported assessments over the 16-week induction period of the phase 2b study. Together with the observed safety profile, these results support further development of rezpeg as a novel biologic AD treatment."

Clinical • Late-breaking abstract • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • CCL2 • CCL22 • FOXP3 • IL2 • IL2RA • ISG20 • POSTN

Nektar Presents New Data from REZOLVE-AD Phase 2b Study for Rezpegaldesleukin in Late-Breaker Oral Presentation at EADV 2025 (PRNewswire) - "Study met primary and key secondary endpoints at week 16 in patients with moderate-to-severe atopic dermatitis. High dose rezpegaldesleukin achieved statistical significance on multiple patient-reported outcome assessments at completion of 16-week induction period. Interim data presented for patients who received placebo during induction period and crossed over to receive 24 weeks of treatment with high dose rezpegaldesleukin show deepening of EASI-75 response to 62% and deepening of vIGA-AD 0/1 response to 38%."

P2b data • Atopic Dermatitis

Nektar Announces REZOLVE-AD Phase 2b Results for Rezpegaldesleukin Selected for Late-Breaker Oral Presentation at EADV 2025 (PRNewswire) - "The presentation will include Phase 2b results on the primary and secondary endpoints from the 16-week induction phase of the REZOLVE-AD study, including multiple patient-reported outcome assessments. The oral presentation will also include new data from patients originally assigned to placebo in the 16-week induction phase who crossed over to high dose rezpegaldesleukin and are receiving ongoing treatment."

Late-breaking abstract • P2b data • Atopic Dermatitis

Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Severe-to-Very Severe Alopecia Areata (PRNewswire) - "Nektar Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms....'We remain on track to announce topline data in December from our ongoing REZOLVE-AA Phase 2b study for rezpegaldesleukin in alopecia areata, and we look forward to the opportunity to collaborate quickly with the agency on a potential registrational program following the completion of Phase 2.'"

Fast track • P2b data • Alopecia

Nektar Therapeutics Reports Second Quarter 2025 Financial Results (PRNewswire) - "...'This quarter, we announced transformative data for rezpegaldesleukin from the Phase 2b study in patients with moderate to severe atopic dermatitis....We look forward to seeing the effect of continued treatment with rezpegaldesleukin when we report the 52-week data in early 2026. In alopecia areata, we will report the data from a separate Phase 2b study in December of this year'."

P2b data • Alopecia • Atopic Dermatitis