Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy. After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed. However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed.
INFORM is a secondary use of data drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.
The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022. If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.

开始日期2024-03-20

申办/合作机构

Bayer AG

[+3]

NCT05658497

/ RecruitingN/A

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).
The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

开始日期2023-10-27

申办/合作机构

Biogen, Inc.

PACTR202205508723236

/ Suspended临床3期IIT

A multi-centre, placebo-controlled studyof interferon beta-1a in high risk COVID-19 outpatients (InterCoV)

开始日期2022-05-15

申办/合作机构-

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项与干扰素β-1a(Biogen, Inc.) 相关的文献（医药）

2026-05-01·Multiple Sclerosis and Related Disorders

Appendicitis and multiple sclerosis disease-modifying therapies: a disproportionality analysis of the FDA adverse event reporting system

Article

作者: Balshi, Alexandra ; Baber, Ursela ; Esser, Madelyn ; Dempsey, John P ; Sloane, Jacob A

BACKGROUND:

Although appendicitis is one of the most common surgical emergencies and is related to immune function, its relation to multiple sclerosis (MS) disease-modifying therapies (DMTs) is unclear.

OBJECTIVE:

To determine which, if any, MS DMTs are associated with disproportionally high appendicitis reporting using real-world data from the FDA Adverse Event Reporting System (FAERS).

RESULTS:

We identified 965 reports of appendicitis associated with MS DMTs. A pooled analysis of all DMTs showed disproportionately high appendicitis reporting compared to all other FAERS medications (reporting odds ratio, 2.83; 95% confidence interval, 2.63-3.06; χ (Bhangu et al., 2015), 787.54). Ocrelizumab, ofatumumab, natalizumab, alemtuzumab, dimethyl and diroximel fumarate, cladribine, and peg- and interferon beta-1a all individually exhibited disproportionally high appendicitis reporting.

CONCLUSION:

Patient counseling on early appendicitis warning signs and indications for urgent evaluation may be warranted for people with MS on DMTs.

2026-05-01·Multiple Sclerosis and Related Disorders

The comparative efficacy of cladribine tablets versus alternative disease-modifying treatments for relapsing-remitting multiple sclerosis: Updated meta-regression estimates by patient subgroup

Review

作者: Maheshwari, Vikalp ; J, Saipriya ; Harty, Gerard T ; Jones, Michelle

BACKGROUND:

A previously published meta-regression compared cladribine tablets with key disease-modifying treatments (DMTs) for patients with relapsing-remitting multiple sclerosis (RRMS). This analysis updates and extends that work by evaluating the relative efficacy of cladribine tablets versus approved DMTs in specific RRMS subgroups, including high disease activity (HDA) and sub-optimal therapy (SOT).

METHODS:

Updated systematic literature reviews identified clinical trials evaluating cladribine tablets and other DMTs in RRMS. Baseline-risk-adjusted meta-regressions were conducted. Outcomes included 6-month confirmed disability progression (6 M-CDP) and annualised relapse rate (ARR).

RESULTS:

Fifty-four clinical trials assessing cladribine tablets plus 19 additional DMTs contributed to the meta-regressions. Results showed significant overlap in the hazard ratio credible intervals, with no therapy statistically dominating in terms of efficacy. At the point-estimate level in the HDA population, for 6 M-CDP, cladribine tablets were predicted to be more efficacious than placebo, fingolimod, alemtuzumab, glatiramer acetate, teriflunomide, ozanimod, interferon beta-1a, ocrelizumab, dimethyl fumarate, and ponesimod; comparable estimates were observed versus ofatumumab. For ARR, cladribine tablets were predicted to be more efficacious than placebo, dimethyl fumarate, glatiramer acetate, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, and teriflunomide, as well as fingolimod, ozanimod, and ponesimod; comparable estimates were observed versus ocrelizumab.

CONCLUSIONS:

Updated meta-regressions demonstrate that cladribine tablets have comparable relative efficacy to other high-efficacy therapies in HDA and SOT patient subgroups. For disability progression outcomes, cladribine tablets showed similar efficacy to ofatumumab; for relapse reduction, cladribine tablets were comparable to ocrelizumab. Cladribine tablets also consistently outperformed most platform therapies across all analyzed subgroups.

2026-04-01·JOURNAL OF CHILD NEUROLOGY

Evaluating Efficacy Outcomes in Pediatric Multiple Sclerosis Patients While Using Avonex or Plegridy via USNPMSC Registry

Article

作者: Mar, Soe ; Abrams, Aaron ; Barney, Bradley J ; Waltz, Michael ; Gorman, Mark ; Rose, John ; Tillema, Jan-Mendelt ; Krupp, Lauren ; Rodriguez, Moses ; Shukla, Nikita ; Lotze, Timothy ; Waubant, Emmanuelle ; Peterson, Skyler ; Rensel, Mary ; Benson, Leslie ; Chitnis, Tanuja ; Wright, Melissa A ; Vignos, Megan ; Casper, T Charles ; Wheeler, Yolanda ; Schreiner, Teri

This study evaluated the efficacy of the multiple sclerosis disease-modifying therapies, intramuscular interferon beta-1a (Avonex) and subcutaneous peginterferon beta-1a (Plegridy), using data from the United States Network of Pediatric Multiple Sclerosis Centers. In this retrospective analysis, 154 patients with multiple sclerosis were included who were treated with Avonex (n = 130), Plegridy (n = 23), or both treatments (n = 1) before the age of 18 years. After 3 months’ sustained use acclimation (“wash-in”), the probability of being relapse-free during the first year was 68.3% for Avonex-treated patients and 69.9% for Plegridy-treated patients; annualized relapse rates were 0.50 and 0.59, respectively. Both disease-modifying therapies demonstrated efficacy similar to that reported in adult populations. Despite the lack of formal approval for pediatric multiple sclerosis, these outcomes indicate that patients may benefit from treatment with Avonex or Plegridy. Understanding efficacy of specific disease-modifying therapies in pediatric multiple sclerosis is essential to making informed treatment decisions.

项与干扰素β-1a(Biogen, Inc.) 相关的新闻（医药）

2026-05-19

·PRNewswire

Immunic Appoints Seasoned Biopharmaceutical Executive Michael W. Bonney as Chair of the Board of Directors

– More Than 30 Years of Leadership Experience Across Biopharmaceutical Commercialization – – Played Key Role in the Launch and Commercial Success of Avonex® for Multiple Sclerosis – NEW YORK, May 19, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced the appointment of Michael "Mike" W. Bonney, a highly experienced biopharmaceutical executive and board leader, as Chair of its Board of Directors, effective May 16, 2026. Simona Skerjanec, M.Pharm, MBA, will transition from Interim Chairperson to continue serving as a member of the Board. Mr. Bonney brings more than three decades of leadership experience in the biopharmaceutical industry, including significant expertise in multiple sclerosis (MS) and broader central nervous system markets. Notably, during his tenure at Biogen Inc., he held senior commercial leadership roles and was closely involved in the launch and growth of Avonex®, one of the first widely adopted therapies for relapsing forms of MS. This treatment helped to build one of the industry's foundational neurology franchises. After his time at Biogen, Mr. Bonney served as Chief Executive Officer of Cubist Pharmaceuticals, where, for more than 10 years, he led the company through a period of significant growth. Most notably, this included the successful commercialization of Cubicin®, an antibiotic medicine, and the company's subsequent acquisition by Merck & Co. for approximately $9.5 billion. Earlier, Mr. Bonney spent over a decade at Zeneca Pharmaceuticals in a range of commercial, operating, and strategic roles, culminating as National Business Director. Throughout his distinguished career, Mr. Bonney has consistently supported companies advancing innovative therapies through late-stage development and commercialization. Mr. Bonney has extensive board leadership experience across the biopharmaceutical sector. In addition to Immunic, he currently serves as Chair of the Board of Autolus Therapeutics plc, Dunad Therapeutics LTD and Santa Ana Bio, Inc. He has also served as Chair or Director of companies including Alnylam Pharmaceuticals, Inc., Bristol Myers Squibb, Celgene Corporation, Kaleido Biosciences, Inc., Magenta Therapeutics, Inc., Sarepta Therapeutics, Inc. and Syros Pharmaceuticals, Inc. "I would like to welcome Mike as Chair of the Board at what is, without question, a defining stage of growth for Immunic," stated Ms. Skerjanec. "His extensive experience in biotech and achievements throughout his career as a CEO, chair and member of the board, as well as his MS experience in the launch and growth of Avonex® during his time at Biogen are all highly relevant as we advance vidofludimus calcium toward potential regulatory approval and commercial readiness." "I am excited to join Immunic at such a pivotal time, ahead of the readout of the phase 3 ENSURE trials of vidofludimus calcium in relapsing MS and the planned phase 3 development program in primary progressive MS," stated Mr. Bonney. "Designed to combine neuroprotective, anti-inflammatory and anti-viral effects, vidofludimus calcium offers a potential differentiated profile within the MS treatment landscape. I look forward to working closely with the entire Board and management team to support Immunic's upcoming milestones and its broader regulatory and commercial strategy." "On behalf of the entire Immunic team, I would like to thank Simona for her strong leadership as Interim Chairperson and her continued role as a member of our Board, going forward," added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "Mike's proven abilities in executive leadership at Cubist, combined with his success in helping to make Avonex® a blockbuster therapy for MS, are attributes that will be invaluable to Immunic in the months and years to come. We look forward to leveraging all of Mike's experience as we plan to transition toward becoming a fully integrated commercial-stage company." About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; changes to the leadership of the board of directors; new appointments to Immunic's board of directors; and the executive and board structure of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] SOURCE Immunic, Inc. 21% more press release views with Request a Demo

临床2期高管变更临床3期并购

2026-04-29

·诺诚健华

港股研究社：创新药的“戴维斯双击”

2026年一季度，我国创新药BD交易总额突破600亿美元，逼近2025年全年交易额的一半。这一爆发式增长是过去十年中国新药审评审批制度改革、本土科研力量积淀以及全球医药供需关系深刻重构的集中体现。在这些深层驱动因素之下，创新药年报业绩的超预期表现水到渠成，整体板块稳健上行。板块持续回暖之中，其中，3月刚摘“U”的诺诚健华年报披露期间（3月25日-4月13日）公司市场关注度显著提升，A股累涨18.15%，H股累涨24.42%，机构净流入额约1.5亿港元，成为近期创新药板块的热点公司之一。当前业绩与公司股价形成共振，戴维斯双击经典桥段再次重现。戴维斯双击”最早是美国著名投资人谢尔比·戴维斯（Shelby Davis）提出的投资策略，在资本市场中通常指代企业盈利增长与市场估值提升的双重效应。高基数下的再提速2025年，诺诚健华交出了成立十年来最漂亮的成绩单——营收23.75亿元，同比增长135.27%；净利润6.4亿元，首次扭亏为盈。相较于国内Biotech从上市到盈利的漫长跋涉，诺诚健华仅用3年时间便完成了进化到“盈利Biopharma”的华丽转身。4月23日晚，诺诚健华发布2026年第一季度财报，药品收入同比上涨44.5%，达到4.5亿元，一季度总营收5.3亿元，同比增长38.7%。公司实现持续性盈利，一季度净利润同比增长607.7%，达到1亿元。管理层在此前的2025年度业绩说明会上表示，预计2026年整体产品收入将实现约35%的同比增长。港股当前的估值水平，呈现出价值修复的潜在特征。在2025年全年卓越表现的基础上，公司2026年第一季度继续保持高质量快速发展。诺诚健华业绩的持续兑现，引发了市场对企业成长性的广泛讨论，包括对估值的新期待。A股与港股两个市场的定价差异，也为观察公司价值提供了一个难得的窗口。在基本面持续向好与市场关注度稳步提升的背景下，港股定价与公司内在价值趋于弥合的过程，或将进入一个更可预期的阶段。从“单兵突进”到“多点开花”核心品种奥布替尼作为诺诚健华业绩的基本盘，继续保持增长。四个获批适应症全部纳入医保；一线CLL/SLL适应症被纳入《CSCO淋巴瘤诊疗指南2025版》指南I级推荐；MZL（边缘区淋巴瘤）独家适应症持续贡献壁垒。但真正让市场重估公司价值的，还有奥布替尼的“第二曲线”——自身免疫性疾病领域。ITP（原发性血小板减少症）的III期临床已完成，公司预计2026年上半年递交上市申请。SLE（系统性红斑狼疮）的IIb期临床达到主要终点，具备成为FIC的潜力，III期注册研究正在推进。MS（多发性硬化）的全球III期临床已启动。这意味着，奥布替尼正从血液瘤的“单兵突进”，迈向“肿瘤+自免”的双轮驱动。尤其值得关注的是奥布替尼独特的血脑屏障穿透优势，其脑脊液暴露量足以显著抑制中枢神经系统内部的B细胞及小胶质细胞，这被视为攻克MS患者“无复发性残疾进展”的关键。目前全球仅有奥瑞利珠单抗获批PPMS，2025年销售额高达70亿瑞士法郎（约85亿美元）。假如奥布替尼能在PPMS和SPMS这一缺乏有效疗法的领域证明其临床价值，有望打开潜力巨大的增长空间。产品矩阵再拓展，从“一品独大”到“三驾马车”2025年，诺诚健华商业化产品矩阵从1个扩展到3个。坦昔妥单抗获批DLBCL适应症，成为中国首个获批的CD19单抗；佐来曲替尼获批，成为国产首个泛TRK抑制剂。其中，坦昔妥单抗瞄准的DLBCL是非霍奇金淋巴瘤中占比最高的亚型，超过一半的复发患者属于该药的目标人群，联合来那度胺的方案已展现出优异疗效（mDOR和mOS较传统方案延长3-4倍），坦昔妥单抗的商业化爬坡值得期待。在研管线的纵深布局同样值得关注。BCL2抑制剂Mesutoclax是诺诚健华血液瘤管线的下一个重磅候选，治疗髓系恶性肿瘤的研究已经入选2026ASCO年会，市场高度关注。Mesutoclax若能以差异化临床数据切入，面对的将是四项适应症（CLL/SLL、MCL、AML、MDS）合计约200亿美元的可触达市场（Frost Sullivan等机构统计数据）。自免板块以两款TYK2抑制剂为核心支点。ICP-332（Soficitinib）目前已经完成中重度特应性皮炎（AD）的III期临床患者入组，预计2026年数据读出，2027年申报上市，其他适应症白癜风、荨麻疹等市场空间都很大ICP-488治疗银屑病的III期已入组完毕，2026年年中至下半年数据读出，后续将向皮肤性狼疮、干燥综合征等多个适应症延展。此外，VAV1、IL-17等靶点都令市场充满期待。早期研发管线方面，靶向B7H3的ADC产品ICP-B794以海报形式在AACR年会发布临床前数据，展现强效抗肿瘤活性及远超同类药物的安全窗口。火热的赛道，需要的是差异化数据，而安全窗口恰恰是ADC药物能否拉开身位的最大变量。诺诚健华“肿瘤+自免”的矩阵化布局，正从蓝图一步步走向现实。结语当一家Biotech终于摘掉“U”的标签，市场真正关心的不再是能否盈利，而是盈利能否持续。如果说2025年是诺诚健华的“盈利证明之年”，2026年则有望成为“价值跃升之年”。ITP的NDA、SLE的III期启动、MS的两项全球III期加速推进、ICP-248的一系列数据读出、ICP-332和ICP-488的III期数据读出——至少4项重大催化剂将在未来12个月内密集释放。当业绩增长（盈利端）与估值修复（估值端）同时发力，正是戴维斯双击最经典的发生场景。信息来源：Roche reports strong 2025 results with 7% sales growthData of InnoCare's Orelabrutinib for the Treatment of MS Released at 2025 ACTRIMS ForumNEJM：Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis21世纪经济报道：诺诚健华在血液肿瘤赛道“狂飙”

财报临床3期CSCO会议引进/卖出申请上市

2026-04-28

·PRNewswire

Immunic Appoints Accomplished Biopharmaceutical Executive Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer

– Proven Leader in Neurology Drug Development, Including for Several Approved Multiple Sclerosis Therapies – – Strong Experience in Advancing Late-Stage Clinical Programs and Obtaining Global Regulatory Approvals, Key to Supporting Vidofludimus Calcium Through Pivotal Development – NEW YORK, April 28, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced the appointment of Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer, effective April 24, 2026. Dr. Panzara will lead the company's development organization, including clinical development, medical affairs, and regulatory affairs, and will be a critical partner to the Chief Executive Officer and the Board of Directors in defining and driving the overall company strategy. Dr. Panzara succeeds Andreas Muehler, M.D., M.B.A.. "Mike is a globally renowned biopharmaceutical executive and drug developer with deep expertise in neurology and proven leadership in advancing transformational therapies through development and the regulatory approval process," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "Notably, during his tenure at Sanofi Genzyme, Mike oversaw the global regulatory approvals of the multiple sclerosis (MS) drugs LEMTRADA® and AUBAGIO®. During his time at Biogen, he served as global clinical lead for the development of TYSABRI® and managed their late-stage portfolio of MS products. His depth of experience will be invaluable as we advance vidofludimus calcium through the pivotal clinical readout of our phase 3 ENSURE trials in relapsing MS, and toward potential regulatory approval and commercialization in this indication. His leadership will support the company strategy as we continue our transition into a fully integrated commercial-stage company." "This is a critically important time in Immunic's evolution and I am excited to be joining the company at such a pivotal inflection point," said Dr. Panzara. "Vidofludimus calcium's potential to treat MS by targeting both immunological and neuroprotective pathways holds promise to redefine the treatment landscape and meaningfully impact the lives of so many people who continue to struggle with their MS. I look forward to building upon the team's successes to further advance Immunic's clinical programs, including the phase 3 ENSURE trials and the planned phase 3 trial of vidofludimus calcium in primary progressive MS." Dr. Panzara brings over 25 years of global neurology experience to Immunic. He most recently served as Chief Medical Officer of Neurvati Neurosciences, Inc., where he built a Development Organization to support the creation of sub-companies focused on advancing therapeutic candidates in neurological and psychiatric disorders. This included serving as Chief Medical Officer of Neurvati's first sub-company, GRIN Therapeutics, overseeing development of radiprodil, a negative allosteric modulator targeting the NMDA receptor as a potential treatment for rare genetically defined neurodevelopmental disorders. Prior to Neurvati, Dr. Panzara served as Chief Medical Officer and Head of Therapeutics Discovery and Development at Wave Life Sciences Ltd., after initially joining the company as Franchise Lead, Neurology, where he oversaw Wave's therapeutic research and development portfolio with a focus on genetically-defined neurological diseases. Earlier, he served as the Head of the Multiple Sclerosis, Neurology and Ophthalmology Therapeutic Area for Global Development at Sanofi Genzyme, where he oversaw global regulatory approvals of the MS drugs LEMTRADA® (alemtuzumab) and AUBAGIO® (teriflunomide) and was responsible for development strategy and oversight within these therapeutic areas. Prior to joining Sanofi Genzyme, Dr. Panzara was Vice President and Chief Medical Officer of Neurology at Biogen. During his time there, he served as the global clinical lead for the development of TYSABRI® (natalizumab) for MS, overseeing its clinical program and global approvals, and managed clinical development activities for all late-stage MS products, including AVONEX® (interferon beta-1a), PLEGRIDY® (PEG-interferon beta-1a), and TECFIDERA® (dimethyl fumarate). He currently serves on the Boards of Directors of LeonaBio, Inc. and Cadenza Bio, Inc.. Dr. Panzara received his undergraduate degree in biology from the University of Pennsylvania and his medical degree from Stanford University School of Medicine. He completed his neurology training at Massachusetts General Hospital and conducted postdoctoral training in immunology and rheumatology at Brigham and Women's Hospital. He also holds a Master of Public Health from the Harvard School of Public Health. Dr. Vitt added, "On behalf of the entire team, I would like to sincerely thank Andreas for his leadership and invaluable contributions as Co-Founder and Chief Medical Officer of Immunic. It is due in large part to his expertise and stewardship that vidofludimus calcium has advanced successfully into late-stage clinical development. That said, we are delighted that he will continue to support the company as a consultant during this key phase for Immunic and our evolution into a fully-fledged commercial company." "It has been a true privilege to serve as Chief Medical Officer of Immunic for the past 10 years," said Dr. Muehler. "During this time, I had the opportunity to build and grow the clinical development organization and advance the company's development pipeline. Most notably, we progressed vidofludimus calcium from the preclinical stage into late-stage clinical development, achieving clinical proof-of-concept in both relapsing and progressive MS, and are now just months away from the pivotal phase 3 readout in relapsing MS. This journey has truly been a team effort. I have been fortunate to work alongside an exceptional group of colleagues, whose dedication and expertise made these achievements possible. I am delighted to pass the baton to Dr. Panzara, whose extensive medical, clinical and regulatory background makes him ideally suited to guide vidofludimus calcium into its next chapter. I am immensely proud of what our team has accomplished and remain highly confident in Immunic's potential to make a meaningful impact in the MS space by delivering a unique and innovative new therapeutic option for patients living with this devastating disease." The Compensation Committee of Immunic's Board of Directors granted Dr. Panzara an initial equity option to purchase 300,000 shares of common stock of the company under the Immunic, Inc. 2026 Inducement Equity Compensation Plan (the "Options"). The Options were granted as an inducement material to Dr. Panzara's commencement of employment pursuant to NASDAQ Listing Rule 5635(c)(4). The Options will be time vested, with one half vesting on the one-year anniversary of April 24, 2026 and one half vesting in equal monthly installments over a period of twenty-four (24) months following the first anniversary of April 24, 2026. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to expectations regarding the appointment of Dr. Panzara and his integration into the company; Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; and the executive and board structure of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] SOURCE Immunic, Inc. 21% more press release views with Request a Demo

临床2期临床3期高管变更临床结果

100 项与干扰素β-1a(Biogen, Inc.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04554	干扰素β-1a(Biogen, Inc.)	L03AB07	DB00060

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
继发进展型多发性硬化	澳大利亚	Biogen Australia Pty Ltd.	2004-05-04
脱髓鞘疾病	欧盟	BIOGEN NETHERLANDS BV	1997-03-13
脱髓鞘疾病	冰岛	BIOGEN NETHERLANDS BV	1997-03-13
脱髓鞘疾病	列支敦士登	BIOGEN NETHERLANDS BV	1997-03-13
脱髓鞘疾病	挪威	BIOGEN NETHERLANDS BV	1997-03-13
复发性多发性硬化	欧盟	BIOGEN NETHERLANDS BV	1997-03-13
复发性多发性硬化	冰岛	BIOGEN NETHERLANDS BV	1997-03-13
复发性多发性硬化	列支敦士登	BIOGEN NETHERLANDS BV	1997-03-13
复发性多发性硬化	挪威	BIOGEN NETHERLANDS BV	1997-03-13
多发性硬化症	美国	Biogen, Inc.	1996-05-17

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
溃疡性结肠炎	临床2期	美国	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	加拿大	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	捷克	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	匈牙利	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	波兰	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	俄罗斯	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	斯洛伐克	Biogen, Inc.	2008-05-01
慢性炎症性脱髓鞘性多发性神经病	临床2期	美国	Biogen, Inc.	2004-02-01
慢性炎症性脱髓鞘性多发性神经病	临床2期	澳大利亚	Biogen, Inc.	2004-02-01
慢性炎症性脱髓鞘性多发性神经病	临床2期	加拿大	Biogen, Inc.	2004-02-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04492475 (CTgov)	临床3期	新型冠状病毒感染	969	Remdesivir+Interferon beta-1a (Remdesivir Plus Interferon Beta-1a)	廠窪鑰積蓋積獵襯艱願(憲範夢構構齋選衊範簾) = 夢襯鬱衊鏇製廠艱膚繭遞獵積鬱憲獵蓋鏇廠築 (餘膚觸壓願襯願鹽淵觸, 艱鏇網淵築範範積範鏇 ~ 鑰遞襯蓋衊鏇遞積淵選) 更多	-	2021-11-22
				Placebo+Remdesivir (Remdesivir Plus Placebo)	廠窪鑰積蓋積獵襯艱願(憲範夢構構齋選衊範簾) = 壓鏇製製積齋築齋膚襯遞獵積鬱憲獵蓋鏇廠築 (餘膚觸壓願襯願鹽淵觸, 鹽鹹顧鬱製憲糧淵築網 ~ 憲築蓋淵網構廠網衊選) 更多
NCT04521400 (Pubmed \| Int Immunopharmacol)	临床2期	新型冠状病毒感染	168	High-dose IFN-β 1a (Recigen) + lopinavir /ritonavir (Kaletra)	餘願鏇簾簾餘廠艱糧簾(鹽餘選範簾積繭鹹廠衊) = 鹹網壓簾顧齋製淵鹽選夢壓簾壓願製築餘獵醖 (積夢網窪簾鏇積淵艱製 ) 更多	不佳	2021-06-29
				Low-dose IFN-β 1a (Recigen) + lopinavir /ritonavir (Kaletra)	餘願鏇簾簾餘廠艱糧簾(鹽餘選範簾積繭鹹廠衊) = 繭選遞襯衊簾窪齋糧壓夢壓簾壓願製築餘獵醖 (積夢網窪簾鏇積淵艱製 ) 更多
NCT00211887 (CombiRx, Pubmed \| Neurology)	临床3期	多发性硬化症	959	Interferon-beta-1a	窪夢醖憲鬱鏇衊願獵範(衊選鑰鑰艱齋鏇範積襯) = After adjustment, anxiety (hazard ratio [HR] 1.25, 95% confidence interval [CI] 1.01-1.55) and dyslipidemia (HR 1.32, 95% CI 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80, 95% CI 0.67-0.97) was associated with a decreased hazard. 餘夢遞膚艱鹽積淵構廠 (繭襯鬱憲鹹餘選顧齋鏇 )	积极	2020-08-04
				Glatiramer acetate
NCT02047734 \| NCT02294058 (SUNBEAM \| RADIANCE, EAN2019)	临床3期	复发性多发性硬化	-	Ozanimod HCl 1 mg/d	鏇鹽壓製鹽繭獵鹹選獵(夢窪蓋糧築餘遞鑰鏇艱) = 襯製廠積鑰網鹹積範簾願餘衊衊齋醖廠憲鬱淵 (壓選壓鹽襯獵獵窪衊廠 ) 更多	积极	2019-06-27
				Ozanimod HCl 0.5 mg/d	鏇鹽壓製鹽繭獵鹹選獵(夢窪蓋糧築餘遞鑰鏇艱) = 艱顧餘壓憲膚糧願餘蓋願餘衊衊齋醖廠憲鬱淵 (壓選壓鹽襯獵獵窪衊廠 ) 更多
ECTRIMS2018	N/A	复发-缓解型多发性硬化	1,866	disease modifying therapies (DMTs) (Patients aged 18-30)	齋艱醖淵築顧顧壓範襯(憲觸範鹽顧艱糧製餘選) = 廠襯繭獵構壓餘艱簾製顧壓鬱鹽鬱餘顧積遞製 (壓襯鹹鏇淵鏇醖窪製鹽 )	积极	2018-10-09
				disease modifying therapies (DMTs) (All ages)	齋艱醖淵築顧顧壓範襯(憲觸範鹽顧艱糧製餘選) = 淵鹽鹽淵鑰顧積衊鹽觸顧壓鬱鹽鬱餘顧積遞製 (壓襯鹹鏇淵鏇醖窪製鹽 )
OPERA I and OPERA II (AAN2018)	临床3期	复发性多发性硬化	-	Ocrelizumab	鹽鹽餘範淵餘糧窪夢築(鏇襯遞夢壓築齋選獵壓) = 醖窪繭鹽糧獵築構齋獵淵鑰顧鏇網壓鏇淵築網 (顧選窪壓蓋糧觸窪積醖 ) 更多	-	2018-04-10
NCT01412333 \| NCT01247324 (OPERA I and II, AAN2018)	临床3期	复发性多发性硬化	-	OCR-OCR	選壓範製遞觸範構鏇網(簾簾夢繭網鑰顧齋顧膚) = 鹽壓壓築構顧壓膚鑰衊憲觸鹽夢網願範齋蓋鏇 (廠齋願獵窪簾簾夢製蓋 )	积极	2018-04-10
				IFN-OCR	選壓範製遞觸範構鏇網(簾簾夢繭網鑰顧齋顧膚) = 夢構醖膚獵鏇範積築淵憲觸鹽夢網願範齋蓋鏇 (廠齋願獵窪簾簾夢製蓋 )
OPERA I and II (AAN2018)	临床3期	复发性多发性硬化	-	Ocrelizumab	積觸顧餘鹹醖範選簾鏇(壓壓構顧選積範鑰繭壓) = 願網壓蓋憲構築艱簾憲餘構鑰餘齋築鏇醖網積 (顧遞鏇憲構構範鏇餘鬱 )	-	2018-04-10
				Interferon-beta-1a	積觸顧餘鹹醖範選簾鏇(壓壓構顧選積範鑰繭壓) = 觸觸衊膚壓襯廠積醖醖餘構鑰餘齋築鏇醖網積 (顧遞鏇憲構構範鏇餘鬱 ) 更多
NCT00179478 (CHAMPIONS10, CTgov)	临床4期	视神经炎 \| 小脑疾病 \| 多发性硬化症 ... 更多	155	interferon beta 1a 30 ug IM once weekly (Immediate Treatment Group)	憲範廠觸網鬱選蓋顧糧 = 範壓願蓋顧觸膚餘構衊餘構醖艱醖淵構選淵網 (顧製簾鹽鏇廠築積醖鑰, 醖築夢膚觸構鹽艱製選 ~ 壓膚網網鬱廠觸衊網簾) 更多	-	2017-09-06
				interferon beta 1a 30 ug IM once weekly (Delayed Treatment Group)	憲範廠觸網鬱選蓋顧糧 = 襯鑰鑰鑰廠鬱憲蓋選鏇餘構醖艱醖淵構選淵網 (顧製簾鹽鏇廠築積醖鑰, 衊顧醖鬱餘夢淵鬱窪製 ~ 鑰鹽鹹壓窪夢憲鬱淵網) 更多
NCT01641120 (CTgov)	N/A	多发性硬化症	20	Avonex (25 Gauge)	遞衊範觸窪觸選齋餘築(顧鏇築獵齋範願遞窪淵) = 糧簾範齋夢觸鏇獵積選衊餘積觸憲蓋願蓋構繭 (夢襯製鹹鏇夢鬱鹹蓋廠, 2.25) 更多	-	2016-02-01
				Avonex (30 Gauge)	遞衊範觸窪觸選齋餘築(顧鏇築獵齋範願遞窪淵) = 鬱鬱蓋繭鬱構選鹽鏇糧衊餘積觸憲蓋願蓋構繭 (夢襯製鹹鏇夢鬱鹹蓋廠, 2.73) 更多