Latest news with #REZOLVE-AD
Yahoo
a day ago
- Business
- Yahoo
Wainwright sets over $100 target for Nektar on ‘paradigm-shifting' data
H.C. Wainwright analyst Arthur He raised the firm's price target on Nektar (NKTR) to $120 from $6.50 and keeps a Buy rating on the shares. The company this morning announced positive results from the induction period of its ongoing Phase 2b REZOLVE-AD study evaluating rezpegaldesleukin in patients with moderate to-severe atopic dermatitis, the analyst tells investors in a research note. Citing the drug's 'highly differentiated mechanism of action' compared to currently approved therapies, H.C. Wainwright believes rezpeg 'has the potential to reshape the treatment landscape' for atopic dermatitis. The firm expects to see further improvement in efficacy in the next clinical data update when the 36-week maintenance data is expected to be reported in Q1 of 2026. Nektar says a 'paradigm-shifting' atopic dermatitis drug 'has arrived.' The stock in midday trading is up 134%, or $12.82, to $22.36. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on NKTR: Disclaimer & DisclosureReport an Issue Nektar price target raised to $120 from $6.50 at H.C. Wainwright Why Is Nektar Therapeutics Stock (NKTR) Up 110% Today? Nektar jumps 130% to $21.90 after atopic dermatitis study success Nektar Therapeutics Announces Positive Phase 2b Trial Results Nektar's rezpegaldesleukin meets endpoints in Phase 2b atopic dermatitis trial Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
2 days ago
- Business
- Yahoo
Strength Seen in Nektar (NKTR): Can Its 12.1% Jump Turn into More Strength?
Nektar Therapeutics (NKTR) shares soared 12.1% in the last trading session to close at $9.54. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 13.2% loss over the past four weeks. The stock rallied as investor optimism grew over the company's review of top-line data from the phase IIb REZOLVE-AD study evaluating its pipeline candidate, rezpegaldesleukin, for treating moderate-to-severe atopic dermatitis. This biopharmaceutical company is expected to post quarterly loss of $2.53 per share in its upcoming report, which represents a year-over-year change of +32.5%. Revenues are expected to be $10.78 million, down 54.1% from the year-ago quarter. Earnings and revenue growth expectations certainly give a good sense of the potential strength in a stock, but empirical research shows that trends in earnings estimate revisions are strongly correlated with near-term stock price movements. For Nektar, the consensus EPS estimate for the quarter has been revised 10.5% higher over the last 30 days to the current level. And a positive trend in earnings estimate revision usually translates into price appreciation. So, make sure to keep an eye on NKTR going forward to see if this recent jump can turn into more strength down the road. The stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> Nektar belongs to the Zacks Medical - Drugs industry. Another stock from the same industry, Indivior PLC (INDV), closed the last trading session 0.4% lower at $13.95. Over the past month, INDV has returned 24.4%. For Indivior, the consensus EPS estimate for the upcoming report has remained unchanged over the past month at $0.25. This represents a change of -43.2% from what the company reported a year ago. Indivior currently has a Zacks Rank of #3 (Hold). Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Nektar Therapeutics (NKTR) : Free Stock Analysis Report Boston Scientific Corporation (BSX) : Free Stock Analysis Report Graco Inc. (GGG) : Free Stock Analysis Report Stem, Inc. (STEM) : Free Stock Analysis Report Compugen Ltd. (CGEN) : Free Stock Analysis Report Modine Manufacturing Company (MOD) : Free Stock Analysis Report Liberty Media Corporation - Liberty Formula One Series A (FWONA) : Free Stock Analysis Report Sutro Biopharma, Inc. (STRO) : Free Stock Analysis Report Progyny, Inc. (PGNY) : Free Stock Analysis Report Indivior PLC (INDV) : Free Stock Analysis Report Cartesian Therapeutics, Inc. (RNAC) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
2 days ago
- Business
- Yahoo
Nektar Therapeutics Stock Doubles After Promising Eczema Drug Trial Results
Shares of Nektar Therapeutics doubled in early trading Tuesday after the U.S. biotech firm said it reached its targets in a midstage study of its eczema treatment. The biotech firm said the global Phase 2b REZOLVE-AD study conducted in 393 patients with moderate-to-severe atopic dermatitis achieved successful results after three subcutaneous treatments of rezpegaldesleukin over 16 weeks. Nektar CEO Howard W. Robin said the study showed 'the promise of Tregs as an important potential therapeutic modality to treat inflammatory skin disorders and other autoimmune conditions.'Shares of Nektar Therapeutics (NKTR) doubled in early trading Tuesday after the U.S. biotech firm said it reached its targets in a midstage study of its eczema treatment. It said the global Phase 2b REZOLVE-AD study conducted in 393 patients with moderate-to-severe atopic dermatitis achieved successful results after three subcutaneous treatments of rezpegaldesleukin over 16 weeks. "These data from REZOLVE-AD show a fast onset of both EASI response and itch relief within the first few doses of rezpegaldesleukin treatment, which are important metrics for physicians as they assess treatment options in atopic dermatitis," Jonathan Silverberg, professor of dermatology at the George Washington University School of Medicine and Health Sciences, said. He added that the drug didn't have an increased risk of conjunctivitis, oral herpes, or oral ulcers, as with some other approaches. Nektar CEO Howard W. Robin said the study showed 'the promise of Tregs as an important potential therapeutic modality to treat inflammatory skin disorders and other autoimmune conditions.' Tregs are T-regulatory cell therapies for autoimmune diseases. Read the original article on Investopedia Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
2 days ago
- Business
- Yahoo
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
SAN FRANCISCO, June 23, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, today 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. Details on how to access the live webcast of the call will be available in the morning press release and on the Nektar website at A replay of the webcast will be available for at least 30 days following the event. 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 and one in alopecia areata. 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 and follow us on LinkedIn. For Investors: Corey Davis, PhDLifeSci Advisors212-915-2577cdavis@ For Media: Madelin HawtinLifeSci Communications603-714-2638mhawtin@ View original content to download multimedia: SOURCE Nektar Therapeutics
Associated Press
10-02-2025
- Business
- Associated Press
Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis
SAN FRANCISCO, Feb. 10, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) 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). In patients with moderate-to-severe atopic dermatitis, rezpegaldesleukin has been shown to rapidly improve measurable exploratory disease outcomes during a 12-week induction treatment phase and for at least 36 weeks after ceasing treatment, demonstrating proof-of-concept in this indication.1 Proof-of-concept efficacy and safety data from a Phase 1b study of rezpegaldesleukin in atopic dermatitis patients were presented at the 2023 EADV Congress in October 2023 ( Presentation Link). 'We are pleased that rezpegaldesleukin has been designated a Fast Track product,' said Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Research & Development Officer at Nektar. 'Rezpegaldesleukin has the potential to address a significant unmet need for the millions of patients living with moderate-to-severe atopic dermatitis. 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. This designation will now allow us to collaborate closely with the agency on the design of the registrational program for rezpegaldesleukin once we've completed Phase 2.' The goal of the FDA's Fast Track process is to ensure that important new treatments reach patients as quickly as possible. The designation is granted to investigational therapies that treat serious conditions and have the potential to address an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent meetings and written interactions with the FDA to discuss the drug candidate's development plan as well as possible eligibility for rolling review and priority review. About REZOLVE-AD The REZOLVE-AD ( NCT06136741) study enrolled 398 patients with moderate-to-severe atopic dermatitis who had not previously received treatment with biologic or JAK inhibitor therapies. Patients randomized across three different dose regimens of rezpegaldesleukin and placebo for a 16-week induction treatment period. Following this period, patients who meet an Eczema Area and Severity Index (EASI) score threshold for advancement to maintenance are re-randomized to one of two maintenance regimens at their original dose level to receive maintenance therapy either once a month or once every three months. The primary endpoint of the Phase 2b study is mean improvement in EASI score at the end of the 16-week induction treatment period. Secondary endpoints include the proportion of patients achieving Validated Investigator Global Assessment (vIGA-AD) of 0 or 1, those achieving EASI-75, and those achieving a greater than or equal to a 4-point improvement in Itch Numeric Rating Scale (NRS). This trial was initiated in October 2023. Patients were enrolled across approximately 110 sites globally with: 67% enrolled in the European countries of Poland, Bulgaria, Germany, Czechia, Spain, Croatia and Hungary; 17% enrolled in the United States; 11% enrolled in Canada; and 5% enrolled in Australia. Patient randomization was stratified based on baseline disease severity measured by vIGA-AD and geographic region. Enrollment criteria in the study included a minimum EASI score of 16.0, a minimum Body Surface Area (BSA) of 10% and a minimum vIGA-AD of 3 at both screening and randomization. Patients who experienced an unstable course of atopic dermatitis between screening and randomization per investigator assessment were excluded from the study. 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 in order 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. Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases. In addition to the REZOLVE-AD study, it is also being evaluated in the REZOLVE-AA study, a randomized, double blind, placebo-controlled Phase 2b clinical trial for treatment of patients with severe-to-very-severe alopecia areata ( NCT06340360). Rezpegaldesleukin is wholly-owned by Nektar Therapeutics. About Atopic Dermatitis Atopic Dermatitis is the most common type of eczema, affecting approximately 30 million people in the United States.2 AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. 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 and one in alopecia areata. 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 and follow Nektar on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements which can be identified by words such as: 'will,' 'announce,' 'potential,' 'may,' 'allow,' 'can,' and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the potential benefits from Fast Track designation, the therapeutic potential of, and future development plans for, rezpegaldesleukin, and the timing for the announcement of rezpegaldesleukin clinical data. 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) a Fast Track designation does not increase the likelihood that rezpegaldesleukin will receive marketing approval in the United States; (ii) 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; (iii) 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); (iv) rezpegaldesleukin is in clinical development, and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (v) 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, 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; (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 8, 2024. 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. For Investors: Vivian Wu of Nektar Therapeutics 628-895-0661 For Media: Madelin Hawtin LifeSci Communications 603-714-2638 [email protected] 1. Silverberg, J.I., Rosmarin, D., Chovatiya, R. et al. The regulatory T cell-selective interleukin-2 receptor agonist rezpegaldesleukin in the treatment of inflammatory skin diseases: two randomized, double-blind, placebo-controlled phase 1b trials. Nat Commun 15, 9230 (2024). 53384-1 2. Hanifin, J. M., Reed, M. L. & Eczema Prevalence and Impact Working Group. A population-based survey of eczema prevalence in the United States. Dermatitis 18, 82–91 (2007).
