Nektar Therapeutics is a research-based biopharmaceutical company which engages in discovering and developing medicines in areas of unmet medical need. Its research and development pipeline of new investigational drugs includes therapies for oncology, immunology and virology. The firm focuses on using new chemistry approaches to make medicines to treat cancer and autoimmune diseases. The company was founded in 1990 and is headquartered in San Francisco, CA.
Clinical Trials
40
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1990
Active, not recruiting
2
5.0%
Completed
27
67.5%
Recruiting
2
5.0%
Terminated
8
20.0%
Withdrawn
1
2.5%
No approval data available
- Nektar Therapeutics has initiated the first two global registrational trials in the Phase 3 ZENITH AD program evaluating rezpegaldesleukin, a first-in-class regulatory T-cell biologic, in patients aged 12 and older with moderate-to-severe atopic dermatitis. - The program includes three 510-patient randomized, double-blind, placebo-controlled trials, with ZENITH AD-3 enrolling treatment-experienced patients beginning in September 2026. - Initial Phase 3 topline data are expected in mid-2028, with a Biologics License Application submission targeted for 2029. - The Phase 3 program is supported by Phase 2b data showing clinically meaningful efficacy, including an up to five-fold increase in EASI-100 between 16 and 52 weeks with monthly and quarterly maintenance dosing.
- Anaveon will present positive clinical data from its ANV600 (sunekafusp alpha) Phase 1 study at ASCO 2026, showing manageable safety profile and encouraging early clinical activity including tumor shrinkage. - The company has strategically pivoted to focus on autoimmune and inflammatory diseases and is actively seeking global partners for its legacy oncology portfolio through various structures. - ANV600 is a first-in-class PD-1-targeted IL-2R-βγ agonist designed to selectively expand tumor-reactive T cells while reducing IL-2-associated toxicities, with potential in checkpoint inhibitor-resistant settings. - The EXPAND-1 study demonstrated clear proof-of-mechanism with preferential proliferation of PD-1+ CD8+ T cells over regulatory T cells and established a recommended Phase 2 dose.
- Nektar Therapeutics' rezpegaldesleukin showed promise in treating severe alopecia areata but narrowly missed statistical significance in its Phase 2b Rezolve-AA trial. - The company attributed the statistical miss to four ineligible patients, claiming the drug met its primary endpoint when these participants were excluded from analysis. - Rezpegaldesleukin demonstrated a 28-30% reduction in hair loss scores compared to 11% for placebo, with a favorable safety profile and low dropout rates. - Despite the mixed results, Nektar plans to advance the drug into Phase 3 testing next year, targeting an autoimmune condition affecting 2% of the population with limited treatment options.
- Nektar Therapeutics will host a conference call on December 16, 2025, to discuss topline results from the 36-week induction treatment period of its Phase 2b REZOLVE-AA clinical trial. - The study evaluates rezpegaldesleukin, a first-in-class regulatory T-cell proliferator, for treating severe-to-very-severe alopecia areata patients. - Rezpegaldesleukin represents a novel therapeutic approach targeting underlying immunological dysfunction in autoimmune diseases through regulatory T-cell stimulation. - The company is also conducting Phase 2b trials for atopic dermatitis and Phase 2 trials for Type 1 diabetes mellitus with the same investigational drug.
- ORIC Pharmaceuticals has appointed Kevin Brodbeck, PhD, as Chief Technical Officer to support the company's transition into late-stage clinical development. - The appointment reflects ORIC's preparation for potential Phase 3 trials of ORIC-944 and enozertinib starting in 2026. - Brodbeck brings over 25 years of experience in technical operations, CMC, and regulatory activities across pharmaceutical development and commercialization. - ORIC's clinical pipeline includes ORIC-944 for prostate cancer and enozertinib for multiple genetically defined cancers targeting resistance mechanisms.
- DelveInsight's 2025 pipeline report reveals over 20 pharmaceutical companies are actively developing 22+ interleukin-2 inhibitor drugs across various clinical stages. - The FDA granted fast track designation to rezpegaldesleukin for moderate to severe atopic dermatitis in February 2025, while nemvaleukin development was discontinued following failed Phase III trial results. - Leading pipeline candidates include Soquelitinib in Phase III for relapsed/refractory PTCL and multiple Phase II programs targeting autoimmune diseases and cancer indications. - The growing prevalence of autoimmune diseases and organ transplant procedures is driving increased demand for IL-2 inhibitors due to their role in preventing immune rejection.
- Nektar Therapeutics completed a secondary stock offering of 4.89 million shares at $23.50 per share, raising approximately $115 million in gross proceeds. - The capital raise resulted in significant dilution for existing shareholders, increasing the company's outstanding shares from 12.4 million to over 17 million. - Funds will support general corporate purposes including drug development and manufacturing, with the company's lead candidate rezpegaldesleukin showing positive results for moderate-to-severe atopic dermatitis. - Investor sentiment turned negative following the announcement, with stock price declining 3% while the S&P 500 gained 0.8%.
- Nektar Therapeutics will announce top-line data from the 16-week induction period of its global Phase 2b REZOLVE-AD trial on June 24, 2025. - The trial evaluates rezpegaldesleukin, a first-in-class regulatory T-cell proliferator, for treating moderate-to-severe atopic dermatitis. - Rezpegaldesleukin represents a novel approach targeting underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. - The company is also conducting a separate Phase 2b trial of the same drug candidate for alopecia areata treatment.
• The moderate to severe atopic dermatitis market is experiencing significant growth with 45+ companies developing over 50 pipeline therapies, driven by rising global prevalence and increased awareness of the condition. • Recent advancements include promising biologics like rezpegaldesleukin (granted FDA fast-track designation), JAK inhibitors such as VC005 and QY201, and novel mechanisms targeting IL-4/IL-13 pathways, offering new hope for patients with inadequate response to current treatments. • Key players including Nektar Therapeutics, Corvus Pharmaceuticals, and Apogee Therapeutics are advancing clinical trials with significant milestones expected in late 2025, potentially transforming the therapeutic landscape for this chronic inflammatory skin condition.
- Mural Therapeutics has terminated its lead IL-2 program nemvaleukin after the candidate failed to meet clinical endpoints, forcing the company to reduce its workforce by 90%. - Nemvaleukin joins a growing list of unsuccessful IL-2 candidates, including Nektar Therapeutics and Bristol Myers Squibb's bempegaldesleukin, which failed in melanoma, renal cell carcinoma, and urothelial cancer trials. - The setback represents another significant blow to the IL-2 therapeutic class, following Nektar's 2022 program discontinuation that resulted in a 70% workforce reduction despite an initial $1.9 billion investment.
