Baricitinib

New data to be presented from the REZOLVE-AA study at EADV, including 6-month off-treatment data for patients with severe-to-very-severe alopecia areata Company to host conference call with investors and analysts on October 1, 2026 at 8:00 AM ET/2:00 PM CET SAN FRANCISCO, Sept. 28, 2026 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) announced today that data from its Phase 2b studies of rezpegaldesleukin in atopic dermatitis and alopecia areata will be presented in three separate oral presentations at the European Academy of Dermatology & Venereology (EADV) Congress 2026, to take place September 30 to October 3, 2026, in Vienna, Austria. The oral presentations include: new data from the REZOLVE-AA study in patients with alopecia areata, including 6-month off-treatment data evaluating the durability of response as measured by the Severity of Alopecia Tool (SALT); previously reported maintenance data from the REZOLVE-AD study in patients with atopic dermatitis; and a late-breaking oral presentation featuring new multi-omic findings from a biomarker sub-study of REZOLVE-AD that was conducted at the Icahn School of Medicine at Mount Sinai. Investor and Analyst Call and Webcast on Thursday, October 1, 2026 at 8:00 AM ET/2:00 PM CET The Company will host an investor conference call and webcast to present the new 6-month (24-week) off-treatment data from REZOLVE-AA in patients with severe-to-very-severe alopecia areata. Nektar management will be joined by Dr. Benjamin Ungar, Director of the Alopecia Center of Excellence and Director of the Rosacea & Seborrheic Dermatitis Clinic at the Kimberly and Eric J. Waldman Department of Dermatology at Mount Sinai. Interested participants can access the live webcast at this LINK. The event, the press release and the slides will also be available on the events section of Nektar's website at . A replay of the webcast will be available for at least 30 days following the event. Details of the Presentations at the EADV Congress 2026 are as follows: Oral Presentation: "Rezpegaldesleukin, a Novel Regulatory T Cell-Inducing Biologic, Demonstrates Efficacy and Safety in Severe-to-Very-Severe Alopecia Areata: 52-Week Results from the Phase 2b REZOLVE-AA Study" Presenter: Dr. David Rosmarin, M.D., Indiana University School of Medicine Session Title: FC04.1D Presentation Date and Time: Thursday, October 1st 16:30 – 16:40 CET Location: Hall N Abstract No: AS-1872 This presentation will include new findings from the 6-month (24-week) off-treatment follow-up period of REZOLVE-AA study, which was completed in September 2026 (not included in abstract). Oral Presentation: "Rezpegaldesleukin Provides Durable and Deepening Improvements in the Signs and Symptoms of Atopic Dermatitis with Monthly and Quarterly Dosing: Results from the Phase 2b REZOLVE-AD Maintenance Part of Study" Presenter: Dr. Thomas Bieber, M.D., Ph.D., M.D.R.A., Ludwig-Maximilians University Session Title: FC02.1B Presentation Date and Time: Thursday, October 1st 10:25 – 10:35 CET Location: Hall N Abstract No: AS-1732 Late-Breaking Oral Presentation: "Multi-omic profiling identifies early molecular responses to rezpegaldesleukin, a novel regulatory T cell-inducing therapy, in atopic dermatitis" Presenter: Dr. Emma Guttman-Yassky, M.D., Ph.D., Icahn School of Medicine at Mount Sinai Session Title: D1T01.2 Presentation Date and Time: Wednesday, September 30th 16:30 – 16:45 CET Location: Hall A Abstract No: LB-219 The full content of accepted abstracts, including late-breaking abstracts, remains under embargo until September 30, 2026 at 07:00 AM CET. The presentations will be made available on Nektar's website at , after each formal presentation. About REZOLVE-AD Phase 2b Study The global 393-patient Phase 2b REZOLVE-AD (NCT06136741) study was conducted in patients with moderate-to-severe atopic dermatitis who had not previously been treated with a JAK inhibitor or other biologic. Patients were randomized (3:3:3:2) to receive subcutaneous rezpegaldesleukin at one of three dose regimens: 24 µg/kg every two weeks (Q2W), 18 µg/kg Q2W, or 24 µg/kg every four weeks (Q4W). A fourth arm received placebo Q2W. Primary and key secondary endpoints were assessed at Week 16. Following the induction period, rezpegaldesleukin-treated patients who achieved EASI percent reductions of at least 50 were re-randomized (1:1) to continue at the same dose level on a Q4W or Q12W regimen through Week 52 in a blinded maintenance period. Placebo patients with EASI percent score reductions of at least 50 continued to receive placebo Q4W. About REZOLVE-AA Phase 2b Study The global 92-patient Phase 2b REZOLVE-AA (NCT06340360) study was conducted in patients with severe-to-very-severe alopecia areata who had not previously been treated with a JAK inhibitor or other biologic. During the initial 36-week induction phase, patients were randomized (3:3:2) to receive one of two rezpegaldesleukin doses or placebo, administered as twice-monthly subcutaneous injections. The primary endpoint was the mean percentage reduction from baseline in the SALT score at Week 36. Key secondary endpoints included the proportion of patients who achieved absolute SALT scores of less than or equal to 30, 20, and 10, along with the exploratory endpoint of the Clinician-Reported Outcomes (ClinRO) Eyebrow and Eyelash Score. The study also included an optional, blinded 16-week treatment extension and a 24-week follow-up period after 36 or 52 weeks of treatment. 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 disease modifying 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. 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, including atopic dermatitis, alopecia areata and Type 1 diabetes. It is wholly owned by Nektar Therapeutics. 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 atopic dermatitis, alopecia areata, and Type 1 diabetes mellitus. Nektar's pipeline also includes 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 is headquartered in San Francisco, California. For further information, visit 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", "can," "develop," "potential," "expand," "address," "may," "plan" and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the safety and efficacy profile and therapeutic potential of, and future development plans for, rezpegaldesleukin, NKTR-0165, NKTR-0166, and NKTR-422, and plans and timing of future clinical trials and data releases. 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, NKTR-0165, NKTR-0166 and NKTR-422 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are investigational agents and continued research and development for these drug candidates 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, NKTR-0165, NKTR-0166 and NKTR-422 are in various stages of preclinical and clinical development, the risk of failure is high and can unexpectedly occur at any stage of development, and there can be no assurance that any such drug candidate will obtain regulatory approval; (iv) data reported from ongoing clinical trials may be preliminary or interim and may change as additional patient data become available or as continuing observations, verifications and analysis are completed; (v) the timing of the initiation or completion 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; (vi) a Fast Track designation does not increase the likelihood that rezpegaldesleukin will receive marketing approval in the United States; (vii) 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 (viii) certain other important risks and uncertainties set forth in our filings with the Securities and Exchange Commission (SEC), including the risks and uncertainties described under the heading "Risk Factors" in our most recent Annual Report on Form 10-K or Quarterly Report, as such risks and uncertainties may be amended or supplemented by our other filings with the SEC. 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 628-895-0661 [email protected] Corey Davis, Ph.D. LifeSci Advisors 212-915-2577 [email protected] For Media: Susan Roberts LifeSci Communications 202-779-0929 [email protected] SOURCE Nektar Therapeutics 21% more press release views with Request a Demo

当地时间，2026年9月25日，礼来官网宣布，其Olumiant（巴瑞替尼片）重磅新适应症已获美国 FDA 批准上市，新适应症为：用于治疗 12 岁及以上重度斑秃（AA）儿科患者。 值得一提的是，此前，巴瑞替尼已在美国获批用于成人中重度活动性类风湿关节炎与重度斑秃的治疗。斑秃俗称“鬼剃头”，是自身免疫性疾病。免疫系统错误攻击毛囊，致头发、眉毛、体毛脱落，重症患者或全秃、普秃。斑秃可发生于任何年龄，但以青年多见，小儿斑秃病情发展迅速且严重引起关注。传统治疗如外用或口服激素、免疫抑制剂，效果不一且有副作用。很多患者治疗后脱发仍反复，原因是异常免疫攻击未被精准阻断。 据公开资料显示，巴瑞替尼（Baricitini）是一种免疫系统用药，属于酪氨酸蛋白激酶（JAK）1/2抑制剂，可阻断JAK激酶家族成员活性，从而抑制炎症的激活。该药最初由Incyte研发，2009年12月礼来入局，以7.55亿美元与Incyte达成合作开发、商业化巴瑞替尼的协议。 2022 年，美国 FDA 批准 Olumiant 用于治疗重度斑秃成人患者，使其成为美国首个获批用于该病症的全身治疗药物。2026年4月，欧盟委员会也批准 Olumiant 用于治疗 12 至 18 岁以下的重度斑秃青少年患者。 此次FDA批准基于BRAVE-AA-PEDS青少年队列（12岁至18岁以下）的36周数据，这是首个且规模最大的、专门针对重度斑秃儿科患者设计的Ⅲ期研究。基线时，患者斑秃严重程度工具（Severity of Alopecia Tool, SALT）评分中位数为100，表明完全性头皮脱发，患者罹患斑秃的平均时长为6.4年。在第36周，每日一次服用巴瑞替尼片的治疗效果如下：42%接受巴瑞替尼4mg治疗的患者和27%接受巴瑞替尼2mg治疗的患者达到80%或以上的头皮毛发覆盖（以SALT评分≤20衡量），安慰剂组这一比例为5%；37%接受巴瑞替尼4mg治疗的患者和21%接受巴瑞替尼2mg治疗的患者达到90%或以上的头皮毛发覆盖（以SALT评分≤10衡量），安慰剂组这一比例为2%； 在基线时存在明显眉毛和睫毛脱发的患者中，巴瑞替尼4mg治疗组患者的眉毛和睫毛覆盖获得改善。 在 12 岁及以上重度斑秃儿科患者中观察到的总体安全性特征，与成人重度斑秃患者的安全性特征一致。 巴瑞替尼最于2017年获得欧盟（EMA）批准上市，同年7月获PMDA批准。2018年获美国FDA批准上市，用于治疗特应性皮炎、类风湿性关节炎和重度斑秃等相关疾病。2021年达到11.15亿美元，成为一款重磅炸弹药物。 在国内，2019年6月，巴瑞替尼（商品名：艾乐明®）在中国获批。并纳入2020版国家医保目录，适应症涵盖类风湿性关节炎与斑秃。截至目前为止，国内已有复星万邦（江苏）、广州绿十字制药、南京海纳制药、江苏德源药业等7家药企获得巴瑞替尼片仿制药生产批文，国产替代原研加速。 反观巴瑞替尼原研药在中国一直不顺利。两大核心专利被判无效，礼来原研药未纳入第12批新国采，遗憾出局。 其核心中国化合物专利（CN200980116857.7）原应2029年3月10日到期，2024年1月29日被国知局宣告全部无效，请求人为南京斯帕克医药。 2024年12月25日，国家知识产权局官网发布一则公告，理论在2036年才到期的巴瑞替尼晶型专利ZL201610136379.8，提前10多年就被宣告全部无效。此次专利无效请求人南京力博维制药。 内容来源：北京药研汇 ↓⭐关注药通社，洞见行业趋势↓