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

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

Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=66 | Not yet recruiting | Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

New P2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Rezpegaldesleukin: “52-week off-study treatment durability data from P2b REZOLVE-AD trial (NCT06136741) for atopic dermatitis in early 2027 (Nektar Therapeutics) - Phase 2b REZOLVE-AD Topline Results from 16-Week Induction

P2 data • Atopic Dermatitis

Rezpegaldesleukin: “Safety of rezpeg for 16-week induction period in this Phase 2b study is consistent with previously observed and reported safety profile”; Atopic dermatitis (Nektar Therapeutics) - Phase 2b REZOLVE-AD Topline Results from 16-Week Induction

P2 data • Atopic Dermatitis

Nektar to Announce Top-line Data from the 16-Week Induction Period in REZOLVE-AD Phase 2b Study of Rezpegaldesleukin, a Regulatory T-cell Proliferator, in Atopic Dermatitis on June 24, 2025 (PRNewswire) - "Nektar Therapeutics...announced it will host an investor call and live webcast to review top-line data from the 16-week induction period in the ongoing global Phase 2b REZOLVE-AD clinical trial of investigational rezpegaldesleukin, a regulatory T-cell (Treg) proliferator, for moderate-to-severe atopic dermatitis on Tuesday, June 24, 2025 at 8:15am ET / 5:15am PT. The data will be provided in a morning press release and presented during the webcast."

P2b data • Atopic Dermatitis

Nektar therapeutics outlines REZOLVE-AD phase 2b data and financial position for Q2 2025 (MSN News) - "Robin announced that top-line data from the 16-week induction period of the REZOLVE-AD Phase 2b study will be shared in June 2025, with the 36-week maintenance period results expected in early 2026...The REZOLVE-AD study aims to establish the efficacy and safety of REZPEG in biologic-naïve patients with moderate-to-severe atopic dermatitis. The Phase 2b study is focused on identifying a dose regimen for Phase 3 trials. Upcoming milestones include top-line data for the alopecia areata Phase 2b study in December 2025 and the initiation of a trial for type 1 diabetes later in the year, funded by TrialNet. The company plans to submit an IND for the TNFR2 agonist antibody program NKTR-0165 by the end of 2025."

IND • New trial • P2b data • Alopecia • Atopic Dermatitis • Diabetes

Nektar Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results (PRNewswire) - "...'With enrollment now complete for the atopic dermatitis...Phase 2b trial, we are on track to report topline data for rezpegaldesleukin in the second quarter...of this year'....'We plan to submit the IND for NKTR-0165 in the second half of this year'."

IND • P2b data • Atopic Dermatitis • Immunology • Inflammation

Safety profile of Rezpegaldesleukin, A Selective Regulatory T-Cell-Inducing Interleukin-2 Conjugate, versus Placebo Based on Aggregate Safety Evaluation of 746 Subjects Enrolled Across 9 Studies (AAD 2025) - P1, P2 | "REZPEG is a novel regulatory T cell stimulating therapy and pooled safety analysis demonstrates a consistent and potentially favorable safety profile. Two Phase 2b, double-blind studies are currently ongoing, evaluating REZPEG in subjects with moderate-to-severe AD (NCT06136741) and severe alopecia areata (NCT06340360)."

Clinical • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Lupus • Psoriasis • Ulcerative Colitis • IL2

A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA) (clinicaltrials.gov) - P2 | N=86 | Active, not recruiting | Sponsor: Nektar Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Alopecia • Dermatology • Immunology

Nektar Therapeutics Announces Completion of Target Enrollment in REZOLVE-AA Phase 2b Clinical Trial of Rezpegaldesleukin in Patients with Severe-to-Very Severe Alopecia Areata (PRNewswire) - "Nektar Therapeutics...announced the company has completed target enrollment in its REZOLVE-AA Phase 2b study of rezpegaldesleukin in patients with severe-to-very-severe alopecia areata....The REZOLVE-AA (NCT06340360) study enrolled patients with severe-to-very-severe alopecia areata who have not received a JAK inhibitor or other biologic. Patients were randomized across two different dose regimens of rezpegaldesleukin or placebo....Patients were enrolled across approximately 30 sites globally with: 62% enrolled in Poland; 24% enrolled in Canada; and 14% enrolled in the United States....'We look forward to reporting our topline data from this study in the fourth quarter of this year'."

Enrollment closed • P2b data • Alopecia

Nektar Announces Clinical Trial Agreement to Evaluate Rezpegaldesleukin in Patients with New Onset Type 1 Diabetes Mellitus (PRNewswire) - "Nektar Therapeutics...today announced a new collaboration agreement to evaluate Nektar's rezpegaldesleukin in patients with new onset stage 3 type 1 diabetes mellitus (T1D)...Under the agreement, TrialNet will conduct the Phase 2 randomized, double-blind, placebo-controlled, clinical trial to investigate the safety and potential efficacy of rezpegaldesleukin in approximately 70 adults and children with new onset stage 3 T1D. Nektar will supply rezpegaldesleukin for the trial and will provide support for the study, including pharmacokinetic and other analyses. Nektar will retain all rights to the rezpegaldesleukin program under the collaboration...'Our goal is to initiate this study in 2025.'"

Commercial • New P2 trial • Type 1 Diabetes Mellitus

Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis (PRNewswire) - "Nektar Therapeutics...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Rezpegaldesleukin is an investigational biologic therapy that targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells (Tregs)...'We remain on track to announce topline data from the induction period of our Phase 2b REZOLVE-AD study in the second quarter of this year.'"

Fast track • P2b data • Atopic Dermatitis

REZOLVE-AD: A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=396 | Active, not recruiting | Sponsor: Nektar Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology