This section highlights FDA-related milestones and regulatory updates for drugs developed by Nektar Therapeutics (NKTR).
Over the past two years, Nektar Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NKTR-255, NKTR-422, and Rezpegaldesleukin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
NKTR-255 - FDA Regulatory Timeline and Events
NKTR-255 is a drug developed by Nektar Therapeutics for the following indication: NKTR-255 is designed to enhance functional NK cell populations.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NKTR-255
- Announced Date:
- December 7, 2024
- Indication:
- NKTR-255 is designed to enhance functional NK cell populations
Announcement
Nektar Therapeutics announced results of its Phase 2 proof-of-concept study evaluating NKTR-255 as an adjuvant treatment to enhance complete response rate (CRR) and durability following CD19-directed CAR-T therapy in patients with relapsed/refractory (R/R) Large B-cell Lymphoma (LBCL) at the 66th ASH Annual Meeting and Exposition in San Diego, California.
AI Summary
Nektar Therapeutics announced positive results from its Phase 2 proof-of-concept study, presented at the 66th ASH Annual Meeting in San Diego. The study evaluated NKTR-255 as an additional treatment alongside CD19-directed CAR-T therapy in patients with relapsed/refractory Large B-cell Lymphoma. Patients who received NKTR-255 reached a 73% complete response rate at six months, compared to 50% in the placebo group. The treatment also showed enhanced CAR T-cell activity by significantly boosting the CD8+ T cells early after administration. NKTR-255 is an investigational IL-15 agonist that works by activating and expanding immune cells, including natural killer cells and CD8+ T cells, to improve both the level and duration of the cancer response. These findings suggest that the use of NKTR-255 could strengthen the durability of responses in patients undergoing CAR-T therapy for LBCL.
Read Announcement
NKTR-422 - FDA Regulatory Timeline and Events
NKTR-422 is a drug developed by Nektar Therapeutics for the following indication: For autoimmune Disorders.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NKTR-422
- Announced Date:
- November 18, 2024
- Indication:
- For autoimmune Disorders
Announcement
Nektar Therapeutics announced its oral presentation highlighting preclinical data on NKTR-422 at the 2024 American College of Rheumatology (ACR) conference, being held in Washington, D.C. from November 14-19, 2024.
AI Summary
Nektar Therapeutics is set to present key preclinical data on its novel CSF-1R agonist, NKTR-422, at the 2024 American College of Rheumatology (ACR) conference in Washington, D.C. from November 14-19, 2024. The presentation, scheduled for November 18 at 3:15 PM EST, will focus on how NKTR-422 fosters inflammation resolution and promotes tissue repair in chronic inflammatory conditions. Unlike currently approved therapies that do not fully restore tissue health, NKTR-422 is engineered to selectively target and reprogram tissue-resident macrophages, leading to sustained activity from a single dose. Data from multiple preclinical models show that the drug can accelerate treatment efficacy, particularly when used alongside standard inflammatory cytokine blockade. This oral presentation is an important step in evaluating NKTR-422’s potential to improve clinical outcomes in conditions characterized by inflammation and tissue damage.
Read Announcement
Rezpegaldesleukin - FDA Regulatory Timeline and Events
Rezpegaldesleukin is a drug developed by Nektar Therapeutics for the following indication: For the treatment of atopic dermatitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Rezpegaldesleukin
- Announced Date:
- June 24, 2025
- Indication:
- For the treatment of atopic dermatitis.
Announcement
Nektar Therapeutics announced statistically significant data from the 16-week induction period of the ongoing Phase 2b REZOLVE-AD study of investigational rezpegaldesleukin, an IL-pathway agonist and regulatory T-cell (Treg) proliferator.
AI Summary
Nektar Therapeutics announced statistically significant data from the 16‑week induction period of its ongoing Phase 2b REZOLVE‑AD study evaluating rezpegaldesleukin, an investigational IL‐pathway agonist that boosts regulatory T cells. The study, conducted in patients with moderate‑to‑severe atopic dermatitis, showed that all doses of rezpegaldesleukin produced a significantly greater reduction in the Eczema Area and Severity Index (EASI) score compared to placebo. Key secondary endpoints—including achieving 75% and 90% improvement in EASI scores, reducing itch, and improvements in other clinical measures—were also met.
The trial results indicate a rapid onset of action, with early symptom relief after only a few doses. Additionally, the dose‑dependent reduction in inflammatory biomarkers supports rezpegaldesleukin’s potential as a first and best‑in‑class immune modulator. Nektar plans to continue evaluating the drug’s long‑term benefits in later stages of the study.
Read Announcement- Drug:
- Rezpegaldesleukin
- Announced Date:
- June 23, 2025
- Estimated Event Date Range:
- June 24, 2025 - June 24, 2025
- Target Action Date:
- June 24, 2025
- Indication:
- For the treatment of atopic dermatitis.
Announcement
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.
AI Summary
Nektar Therapeutics announced it will host an investor call and live webcast on Tuesday, June 24, 2025, at 8:15am ET (5:15am PT) to present top-line data from the 16-week induction period of its global Phase 2b REZOLVE-AD clinical trial. The trial is studying rezpegaldesleukin, a novel regulatory T-cell (Treg) proliferator, as an investigational treatment for moderate-to-severe atopic dermatitis. The data release aims to update investors on the progress of this innovative immunotherapy, which targets the underlying immune dysfunction linked to the condition. Details on how to access the live webcast will be provided in the morning press release and on the Nektar website. Additionally, a replay will be available for at least 30 days after the event to ensure that all interested parties can review the results and insights presented during the session.
Read Announcement- Drug:
- Rezpegaldesleukin
- Announced Date:
- February 26, 2025
- Indication:
- For the treatment of atopic dermatitis.
Announcement
Nektar Therapeutics nnounced the company has completed target enrollment in its REZOLVE-AA Phase 2b study of rezpegaldesleukin in patients with severe-to-very-severe alopecia areata.
AI Summary
Nektar Therapeutics announced that it has successfully completed target enrollment in its REZOLVE-AA Phase 2b study of rezpegaldesleukin for patients with severe-to-very-severe alopecia areata. The trial enrolled 84 patients who have not previously received a JAK inhibitor or other biologic treatment. Rezpegaldesleukin is an investigational biologic that works by targeting the interleukin-2 receptor complex in the body to stimulate regulatory T cells, which are important for controlling immune responses. This study aims to evaluate the potential of rezpegaldesleukin to reduce hair loss as measured by the Severity of Alopecia Tool (SALT) score, with further analysis on the percentage of patients achieving significant improvements during the 36-week induction period. The trial has enrolled patients from around the world, including sites in Poland, Canada, and the United States, and topline data is expected later this year.
Read Announcement- Drug:
- Rezpegaldesleukin
- Announced Date:
- February 10, 2025
- Indication:
- For the treatment of atopic dermatitis.
Announcement
Nektar Therapeutics 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.
AI Summary
Nektar Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational biologic therapy, rezpegaldesleukin, for treating moderate-to-severe atopic dermatitis in patients ages 12 and older. This designation is intended for treatments that address serious conditions and unmet medical needs, allowing for more frequent interactions with the agency and an expedited review process. Rezpegaldesleukin works by targeting the interleukin-2 receptor complex, which helps stimulate regulatory T cells that can balance the immune response. The therapy is aimed at patients whose condition is not adequately managed by topical prescription treatments or for whom those treatments are not advisable. This Fast Track status highlights the potential of rezpegaldesleukin to offer a new treatment option for both adult and pediatric patients suffering from this challenging skin disorder.
Read Announcement- Drug:
- Rezpegaldesleukin
- Announced Date:
- January 10, 2025
- Indication:
- For the treatment of atopic dermatitis.
Announcement
Nektar Therapeutics announced the company has completed target enrollment in its REZOLVE-AD Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis.
AI Summary
In January 2025, Nektar Therapeutics announced that it has reached its target enrollment for the REZOLVE-AD Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis. The trial enrolled 396 patients across about 110 global sites, with the majority of enrollments coming from Europe. Rezpegaldesleukin is designed as a first-in-class interleukin-2 receptor agonist that works by stimulating regulatory T cells, potentially restoring balance to the immune system and reducing inflammation in the skin.
Early clinical results have shown that the treatment increases Tregs safely and produces promising, dose-dependent improvements in skin outcomes. The study will measure changes using the Eczema Area and Severity Index over a 16-week induction period, with topline data expected in the second quarter of 2025, potentially offering a new treatment option for those affected by this chronic condition.
Read Announcement
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