REZOLVE-AA Phase 2b Study of Rezpegaldesleukin Establishes Proof-of-Concept in Patients with Severe-to-Very-Severe Alopecia Areata

Rhea-AI Summary

Nektar Therapeutics (Nasdaq: NKTR) reported topline 36-week results from the Phase 2b REZOLVE-AA trial of rezpegaldesleukin in 92 patients with severe-to-very-severe alopecia areata. Both dose arms showed mean SALT score reductions of 28.2% (24 µg/kg) and 30.3% (18 µg/kg) versus 11.2% for placebo; the primary endpoint narrowly missed statistical significance in the mITT population. Excluding four patients with major eligibility violations, the primary endpoint reached significance (29.6% and 30.4% vs 5.7%, p=0.049 and p=0.042). Key secondary outcomes (SALT30, SALT≤30/20/10) favored treatment. Safety was described as well tolerated with mostly mild-to-moderate TEAEs and a 1.4% discontinuation rate in treatment arms. Nektar plans to advance rezpegaldesleukin to Phase 3 in 2026 and will present additional data in 2026.

Positive

• Mean SALT reduction ~28–30% at Week 36 for treatment arms
• Statistical significance achieved when excluding 4 ineligible patients (p=0.049, p=0.042)
• SALT30 responder rates 48.9% and 45.7% vs 19.1% placebo
• Favorable safety with 1.4% discontinuation in treatment arms

Negative

• Primary endpoint narrowly missed significance in mITT (p=0.186 and p=0.121)
• Statistical significance depends on exclusion of 4 patients with eligibility violations
• Study not powered for secondary endpoints
• Small sample size: N=92 across three arms

News Market Reaction

-7.77% 2.6x vol

35 alerts

-7.77% News Effect

+3.0% Peak Tracked

-22.5% Trough Tracked

-$91M Valuation Impact

$1.08B Market Cap

2.6x Rel. Volume

On the day this news was published, NKTR declined 7.77%, reflecting a notable negative market reaction. Argus tracked a peak move of +3.0% during that session. Argus tracked a trough of -22.5% from its starting point during tracking. Our momentum scanner triggered 35 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $91M from the company's valuation, bringing the market cap to $1.08B at that time. Trading volume was elevated at 2.6x the daily average, suggesting increased selling activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patients enrolled: 92 patients Primary endpoint SALT reduction: 28.2% vs 11.2% Primary endpoint SALT reduction: 30.3% vs 11.2% +5 more

8 metrics

Patients enrolled 92 patients Global Phase 2b REZOLVE-AA study population

Primary endpoint SALT reduction 28.2% vs 11.2% Week 36 mean % SALT reduction, 24 µg/kg vs placebo (mITT)

Primary endpoint SALT reduction 30.3% vs 11.2% Week 36 mean % SALT reduction, 18 µg/kg vs placebo (mITT)

Primary endpoint (excl. violations) 29.6% vs 5.7% Week 36 mean % SALT reduction, 24 µg/kg vs placebo; p=0.049

Primary endpoint (excl. violations) 30.4% vs 5.7% Week 36 mean % SALT reduction, 18 µg/kg vs placebo; p=0.042

Key secondary SALT30 48.9% vs 19.1% Patients with ≥30% SALT reduction, 24 µg/kg vs placebo

Discontinuation rate 1.4% Discontinuations due to adverse events in combined active arms

Mild ISRs 87.0% Injection site reactions reported as mild in REZPEG-exposed patients

Market Reality Check

Price: $37.33 Vol: Volume 425,557 is below t...

normal vol

$37.33 Last Close

Volume Volume 425,557 is below the 20-day average of 602,573 (relative volume 0.71x) ahead of the data release. normal

Technical Shares at $53.30 are trading above the 200-day MA of $30.85, reflecting a pre-existing uptrend into the Phase 2b topline.

Peers on Argus

NKTR’s move contrasted with a mixed biotech peer set: among close peers, QURE sh...

1 Up

NKTR’s move contrasted with a mixed biotech peer set: among close peers, QURE showed notable upside momentum (+14.54% in scanner) while others like SANA and SYRE were down modestly and PRAX, ABUS were up. No broad, synchronized sector move is indicated.

Historical Context

5 past events · Latest: Dec 15 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 15	Clinical call notice	Neutral	-2.6%	Announcement of today’s topline REZOLVE-AA call and webcast scheduling.
Dec 05	Inducement grants	Neutral	+0.7%	Disclosure of stock option inducement grants for two newly hired employees.
Nov 08	Clinical data update	Positive	+3.6%	REZOLVE-AD Phase 2b data showing statistically significant efficacy in AD with asthma.
Nov 06	Quarterly earnings	Neutral	+1.6%	Q3 2025 results with cash of <b>$270.2M</b> and continued operating losses.
Oct 30	Conference participation	Neutral	+5.3%	Announcement of a Jefferies Global Healthcare Conference fireside chat webcast.

Pattern Detected

Recent news — from clinical updates to earnings and conferences — has generally aligned with modestly positive price reactions, with no clear pattern of selling on good news.

Recent Company History

Over the last few months, Nektar has highlighted multiple rezpegaldesleukin milestones, including new REZOLVE-AD Phase 2b data on Nov 8, 2025 and Fast Track/clinical progress detailed in Q3 results on Nov 6, 2025. Corporate activity included conferences and inducement grants. A Dec 15, 2025 call announcement for today’s REZOLVE-AA topline preceded a -2.56% move. Today’s alopecia areata proof-of-concept data extend this multi-indication development narrative.

Market Pulse Summary

The stock moved -7.8% in the session following this news. A negative reaction despite encouraging ef...

Analysis

The stock moved -7.8% in the session following this news. A negative reaction despite encouraging efficacy could fit a pattern of investors focusing on trial nuances, such as the primary endpoint narrowly missing significance in the full analysis set, or concerns about future funding rather than the mechanism itself. With the stock at $53.30, well above the $6.48 52-week low and past capital raises disclosed, some holders might reassess risk-reward after a strong pre-data run.

Key Terms

phase 2b, il-2, regulatory t-cell, placebo, +4 more

8 terms

phase 2b medical

"topline results from the 36-week induction treatment period of the Phase 2b REZOLVE-AA trial"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

il-2 medical

"rezpegaldesleukin, a first-in-class IL-2 pathway agonist and regulatory T-cell (Treg) proliferator"

Interleukin-2 (IL-2) is a small protein the body uses as a messenger to tell immune cells when to grow and act, like a coach sending signals to players on a team. For investors, IL-2 matters because drugs that boost, mimic, or block its activity can change how well immune therapies work and what side effects they cause, affecting clinical trial success, regulatory approval prospects, and commercial value.

regulatory t-cell medical

"a first-in-class IL-2 pathway agonist and regulatory T-cell (Treg) proliferator"

Regulatory T cell (often called a Treg) is a type of white blood cell that acts like a brake or thermostat for the immune system, calming or shutting down immune reactions to prevent damage to healthy tissue. For investors, Tregs matter because drugs or therapies that boost, block, or reprogram these cells can treat a range of conditions—autoimmune disease, transplant rejection, and cancer—so changes in Treg science can drive new drug pipelines and market opportunities.

placebo medical

"rezpegaldesleukin doses or placebo, administered as a subcutaneous injection twice-monthly"

A placebo is an inactive pill, injection or procedure that looks and feels like the real treatment but contains no therapeutic ingredient, often called a sugar pill. Investors care because comparing a drug to a placebo reveals whether observed benefits come from the medicine itself or from expectation; clear superiority over placebo reduces regulatory and commercial risk, much like a blind taste test proves a new recipe really tastes better.

treatment-emergent adverse events medical

"nearly all treatment-emergent adverse events (TEAEs) mild-to-moderate in severity"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

p<0.05 medical

"achieving statistical significance (p<0.05) when excluding four patients"

A p-value less than 0.05 indicates that there is less than a 5% chance the observed result happened by random chance alone. For investors, this suggests that the finding is likely meaningful and not just a coincidence, providing greater confidence that the observed effect or relationship is real. In essence, it helps determine whether a result is statistically significant and worth paying attention to.

atopic dermatitis medical

"strong and differentiated clinical efficacy data already established in atopic dermatitis"

A chronic inflammatory skin condition, often called eczema, that causes dry, itchy, red patches and recurring flare-ups; think of it as a persistent rash that can come and go over a person’s life. It matters to investors because its chronic nature and large patient population create steady demand for treatments, influence drug development and approval decisions, affect healthcare costs and reimbursement, and can drive revenue and valuation shifts for companies working on therapies and diagnostics.

fast track regulatory

"leverage rezpegaldesleukin's existing Fast Track designation with the goal of making"

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

AI-generated analysis. Not financial advice.

Achieved target product profile on the primary endpoint, with a mean percent reduction in SALT score at 36 weeks of 28.2% in the 24 µg/kg arm versus 11.2% in placebo

Mean percent reduction in SALT scores at 36 weeks was 30% for both treatment arms versus 6% for placebo, achieving statistical significance (p<0.05) when excluding four patients that did not meet major study eligibility criteria at baseline

Safety profile showed rezpegaldesleukin was well tolerated and was consistent with previously reported results

Study results establish Phase 3 dose and support planned advancement to Phase 3 development in alopecia areata

Conference call and webcast with management and alopecia areata experts today at 8:00 am ET

SAN FRANCISCO, Dec. 16, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, today announced topline results from the 36-week induction treatment period of the Phase 2b REZOLVE-AA trial of investigational rezpegaldesleukin, a first-in-class IL-2 pathway agonist and regulatory T-cell (Treg) proliferator.

The global Phase 2b study is being conducted in 92 patients with severe-to-very-severe alopecia areata. Patients were randomized (3:3:2) to receive one of two rezpegaldesleukin doses or placebo, administered as a subcutaneous injection twice-monthly. The primary endpoint was the mean percentage reduction from baseline in the Severity of Alopecia Tool (SALT) score at Week 36. Following 36 weeks, patients who demonstrated hair growth but had not yet reached SALT>20 had the option to continue for an additional 16 weeks of treatment through Week 52 in a blinded extension period. Primary and secondary endpoints were assessed at the end of the 36-week induction treatment period.

Phase 2b Efficacy Data Achieve Target Product Profile

Both rezpegaldesleukin dose arms more than doubled the SALT score reduction treatment effect observed with placebo, with the majority of patients experiencing hair growth at Week 16 or later.  

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.

Four of 92 patients included in the modified intent-to-treat (mITT) analysis were found to have major study eligibility violations that should have disqualified them for randomization into the trial.

Both rezpegaldesleukin treatment arms met statistical significance on the primary endpoint when excluding the four patients with major study eligibility violations. 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). Importantly, the absolute treatment effect for the rezpegaldesleukin arms was similar with or without the exclusion of eligibility violations. One patient in the placebo arm with an eligibility violation accounted for the 5.5% difference in the performance of the placebo arm.

"With strong and differentiated clinical efficacy data already established in atopic dermatitis and comorbid asthma for this first-in-class Treg mechanism, these results provide a compelling proof-of-concept for rezpegaldesleukin in a second inflammatory skin disease," said Jonathan Silverberg, MD, PhD, MPH, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences. "As physicians, we have long been in search of an effective biologic for alopecia areata, given the safety limitations and prescribing burden of JAK inhibitors. Importantly, this is the first biologic to show a truly meaningful level of clinical effect in patients, which could expand the number of patients we can treat with this immune disorder."

Both rezpegaldesleukin treatment arms showed a dose dependent clinical treatment effect as compared to placebo on the key secondary endpoints of SALT ≤30, SALT≤20 and SALT≤10 and SALT₃₀.

David Rosmarin, MD, Chair of the Department of Dermatology and Associate Professor of Dermatology at the Indiana University School of Medicine, added, "These study results demonstrate that treatment with rezpegaldesleukin can lead to meaningful hair regrowth in patients with alopecia areata, including eyebrow and eyelash growth. Importantly, this occurs without the burdens of intensive testing and monitoring for dermatologists and without serious safety concerns. Currently, the only biologic recommended in national guidelines for alopecia areata is dupilumab, which has demonstrated only marginal efficacy. These data suggest that rezpegaldesleukin is a safe and well-tolerated biologic that should be advanced into Phase 3 development as a first-line treatment for patients with severe-to-very-severe alopecia areata, and potentially for those with moderate disease."

Primary and Secondary Efficacy Endpoint Results from 36 Week Induction Treatment in REZOLVE-AA

	24 µg/kg q2w	18 µg/kg q2w	Placebo
Primary Endpoint	N=35	N=37	N=20
Mean % SALT reduction at Week 36	28.2% P=0.186	30.3% P=0.121	11.2 %
Results excluding 4 patients with major study eligibility violations
Primary Endpoint	N=33	N=36	N=19
Mean % SALT reduction at Week 36	29.6% P=0.049	30.4% P=0.042	5.7 %
Key Secondary Endpoints
SALT ≥ 30% reduction from baseline (SALT30)	48.9 %	45.7 %	19.1 %
Absolute SALT ≤ 30	29 %	21.9 %	8.4 %
Absolute SALT ≤ 20	15.6 %	14.8 %	6.7 %
Absolute SALT ≤ 10	11.5 %	8.3 %	0.7 %

Study is not powered to demonstrate statistical significance for secondary endpoints.

"With outstanding results already achieved for rezpegaldesleukin in our atopic dermatitis study, these REZOLVE-AA data now provide clear proof of concept in a second, large potential indication, thereby broadening the number of patients that could benefit from this first-in-class Treg mechanism," said Howard W. Robin, President and CEO of Nektar Therapeutics. "In 2026, we plan to advance rezpegaldesleukin into a Phase 3 program for the treatment of alopecia areata and leverage rezpegaldesleukin's existing Fast Track designation with the goal of making this important potential treatment available to patients worldwide as soon as possible."

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.

Rezpegaldesleukin Well Tolerated with Safety Profile Consistent with Previously Reported Results

Consistent with prior studies, a favorable safety and tolerability profile was observed, with nearly all treatment-emergent adverse events (TEAEs) mild-to-moderate in severity and self-resolving, even in patients receiving 52 weeks of treatment. The discontinuation rate due to adverse events was 1.4% in the combined rezpegaldesleukin treatment arms. No patients discontinued treatment due to an injection site reaction (ISR). The placebo adjusted-ISR rate was consistent with prior studies, with 87.0% of ISRs reported as mild. There was no increased risk of major adverse cardiovascular events, thrombosis, infection, acne or oral herpes for REZPEG-exposed patients, compared to placebo.

Conference Call and Webcast to Discuss Results of Phase 2b REZOLVE-AA Trial

Nektar management will host a conference call and live webcast today, December 16, 2025, to review the results at 8:00 a.m. Eastern Time / 5:00 a.m. Pacific Time. Drs. Silverberg, Rosmarin and Benjamin Ungar, Assistant Professor, Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai, will be joining the call.

The accompanying slides and the webcast of the conference call can be accessed through a link on Nektar's website on the investor relations page. To access the webcast directly, please click on the following link to register to join the webcast: https://events.q4inc.com/attendee/988285219.

The event, the press release and the slides will also be available on the events section of the Nektar website at https://ir.nektar.com/events-and-presentations/events. A replay of the webcast will be available for at least 30 days following the event.

About REZOLVE-AA

The REZOLVE-AA (NCT06340360) study enrolled patients with severe-to-very-severe alopecia areata who have not previously been treated with a JAK inhibitor or other biologic. Patients were randomized across two different dose regimens of rezpegaldesleukin or placebo. The trial completed enrollment in February 2025, with patients enrolled across approximately 30 sites globally, with 62% of patients in Poland; 24% in Canada; and 14% in the United States.

The primary endpoint was the mean percentage reduction from baseline in the Severity of Alopecia Tool (SALT) score at Week 36. Key secondary endpoints include the proportion of patients that achieved absolute SALT scores of less than or equal to 30, 20, and 10, along with the exploratory endpoint of the Clinical-Reported Outcomes (ClinRO) Eyebrow and Eyelash Score.

Enrollment criteria in the study included a diagnosis of severe-to-very-severe alopecia areata (≥ 50% scalp involvement) as measured using the SALT score at both screening and randomization. Patients who experienced an unstable course of alopecia areata over the last 6 months per investigator assessment or had inadequate washout of prior alopecia areata treatments (within 8 weeks) were excluded from the study. Patients with diffuse alopecia and other forms of alopecia were also excluded. Patient randomization was stratified based on baseline disease severity as measured by a SALT score of ≥50 or less than 95% (severe) and ≥95 (very severe). Enrollment of very severe patients was capped at 25%.

About Rezpegaldesleukin

Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. Rezpegaldesleukin is a potential first-in-class resolution therapeutic that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It targets the interleukin-2 receptor complex in the body to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, rezpegaldesleukin may act to bring the immune system back into balance.

In February 2025, the U.S. Food and Drug Administration (FDA) 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. In July 2025, the FDA granted Fast Track designation for rezpegaldesleukin for the treatment of severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kg.

Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases. It is wholly owned by Nektar Therapeutics.

About Alopecia Areata

Alopecia areata is a disease where a patient's own immune system attacks hair follicles resulting in hair loss.¹ The lifetime incidence of alopecia areata is 2% in both men and women.¹ Nearly 6.7 million people in the U.S. and 160 million worldwide develop alopecia areata in their lifetime. About 700,000 people in the U.S. currently have some form of alopecia areata.² It is often associated with other auto-immune conditions as well as depression and anxiety.³ The disease has a tremendous impact on quality of life for patients.³ Available therapies for alopecia are not durable and have high relapse rates and there is an urgent unmet medical need for novel, more effective therapies for patients.

About Nektar Therapeutics

Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis, one in alopecia areata, and in one Phase 2 clinical trial in Type 1 diabetes mellitus. Nektar's pipeline also includes a preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody and bispecific programs, NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422. Nektar, together with various partners, is also evaluating NKTR-255, an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer, in several ongoing clinical trials.

Nektar is headquartered in San Francisco, California. For further information, visit www.nektar.com and follow us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements which can be identified by words such as: "will," "expect," "develop," "potential," "plan," and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the therapeutic potential and safety profile of, and future development plans for, rezpegaldesleukin, the results and timing for reporting the data from the patients ongoing in the 16-week treatment extension of REZOLVE-AA, the Company's plan to submit for presentation and present the REZOLVE-AA results at a medical conference in 2026, the potential for rezpegaldesleukin to be a first-in-class T regulatory cell therapy, the potential market opportunity in alopecia areata, the advantage of a broad-based Treg mechanism over other immune-modulation approaches in development to treat alopecia areata, and the high unmet need for a new mechanism of action in alopecia areata. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of rezpegaldesleukin are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin is an investigational agent and continued research and development for this drug candidate is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin is in clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) a Fast Track designation does not increase the likelihood that rezpegaldesleukin will receive marketing approval in the United States; (vi) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2025. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contacts:

For Investors:

Vivian Wu
VWu@nektar.com

Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
212-915-2577

Ahu Demir, Ph.D.
LifeSci Advisors, LLC
ademir@lifesciadvisors.com
212-915-3820

For Media:

Jonathan Pappas
LifeSci Communications
857-205-4403
jpappas@lifescicomms.com

1. Lintzeri, D.A., Constantinou, A., Hillmann, K., Ghoreschi, K., Vogt, A. and Blume- Peytavi, U. (2022), Alopecia areata – Current understanding and management. JDDG: Journal der Deutschen Dermatologischen Gesellschaft, 20: 59-90. https://doi.org/10.1111/ddg.14689
2. National Alopecia Areata Foundation
3. Alhanshali L, Buontempo MG, Lo Sicco KI, Shapiro J. Alopecia Areata: Burden of Disease, Approach to Treatment, and Current Unmet Needs. Clin Cosmet Investig Dermatol. 2023;16:803-820 https://doi.org/10.2147/CCID.S376096

 

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SOURCE Nektar Therapeutics

FAQ

What were the Week 36 mean SALT reductions for NKTR rezpegaldesleukin in REZOLVE-AA?

Mean SALT reductions were 28.2% (24 µg/kg) and 30.3% (18 µg/kg) versus 11.2% for placebo at Week 36.

Did the REZOLVE-AA Phase 2b trial meet its primary endpoint for NKTR (Dec 16, 2025)?

The primary endpoint narrowly missed significance in the mITT population but reached significance after excluding four patients with major eligibility violations.

What safety findings did Nektar report for rezpegaldesleukin (NKTR)?

Safety was described as well tolerated with mostly mild-to-moderate TEAEs, 87% mild ISRs, and a 1.4% discontinuation rate in treatment arms.

Will NKTR advance rezpegaldesleukin to Phase 3 and when?

Nektar plans to advance rezpegaldesleukin into a Phase 3 program in 2026 and to present additional data at a medical conference in 2026.

How did key secondary endpoints perform in the REZOLVE-AA trial for NKTR?

Key secondary outcomes favored treatment: SALT30 rates were 48.9% and 45.7% for active arms versus 19.1% for placebo.

How many patients were enrolled in the NKTR REZOLVE-AA Phase 2b study?

The global Phase 2b trial enrolled 92 patients randomized 3:3:2 between two doses and placebo.

Why did statistical significance change after excluding four patients in the NKTR trial?

Four patients in the mITT population had major study eligibility violations; excluding them lowered the placebo response to 5.7%, producing significant p-values for both dose arms.