Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease

Purpose: Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. Eligibility: Individuals with PAD will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have a positive history of exercise-limiting claudication (Fontaine II or III), 3) do not have renal impairments, 4) do not have Fontaine stage IV PAD, and 5) are not currently pregnant or nursing. Age-matched controls will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have an ABI greater than 0.9 (no PAD), 3) do not have exercise-limiting diseases or injuries, 4) do not have renal impairments, and 5) are not currently pregnant or nursing. Intervention and Evaluation: During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. Follow-up: There will be a follow-up visit to assess blood work after diroximel fumarate.

开始日期2024-11-14

申办/合作机构

University of Nebraska

NCT05767736

/ Active, not recruitingN/A

An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera

The primary objective of the study is to estimate the incidence rate of serious adverse events (SAEs), including but not limited to malignancies and serious and opportunistic infections, among participants with MS treated with Vumerity, Tecfidera, other selected disease modifying therapies (DMTs [teriflunomide, beta interferons, or glatiramer acetate]), or Vumerity after switching from Tecfidera. The secondary objective of the study is to compare the incidence rate of SAEs, including but not limited to malignancies and serious and opportunistic infections, among MS participants treated with Vumerity, Tecfidera, and Vumerity after switching from Tecfidera with the incidence rate of MS participants treated with other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate), if the sample size allows.

开始日期2024-06-08

申办/合作机构

Biogen, Inc.

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.

100 项与富马酸地罗西美相关的临床结果

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100 项与富马酸地罗西美相关的专利（医药）

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项与富马酸地罗西美相关的文献（医药）

2025-01-01·COMPARATIVE BIOCHEMISTRY AND PHYSIOLOGY C-TOXICOLOGY & PHARMACOLOGY

Time-restricted feeding modulates gene expression related with rhythm and inflammation in Mongolian gerbils

Article

作者: Yang, Lin ; Wang, Chen-Zhu ; Zhang, Xue-Ying ; Wang, Xi-Zhi ; Wang, De-Hua ; Wang, Zhen-Shan

Time-restricted feeding (TRF) has the potential to modulate circadian rhythm and widely studied in humans and laboratory mice. However, less is known about the physiological responses to TRF in wild mammals. Here, we used Mongolian gerbils, Meriones unguiculatus, to explore the effect of 6-week TRF on gene expression related with circadian rhythm and inflammation. The TRF gerbils had higher cumulative food intake than the ad libitum (AL) group, but body mass, feeding frequency/time and metabolic rate did not differ between groups. In the hypothalamus, downregulation of rhythm-related genes Per3, Cry1 and Dbp was detected in the daytime-restricted feeding (DRF) group and Cry1 was downregulated in the nighttime-restricted feeding (NRF) group. In the liver, the expression of Per1/3, Rev-erbα/β and Dbp was lower, and Bmal1 was higher in the DRF than in AL group, while NRF gerbils showed no changes. In the colon, the expression of Bmal1 and Cry1 was higher but Per3, Rev-erbα/β and Dbp were lower in the DRF than in AL group. Further, the expression of inflammation-related genes such as NF-κB, IL-1β, IL-18 and Nlrp3 was lower in the liver of DRF gerbils, and IL-1β was lower both in the hypothalamus and liver of NRF gerbils. Moreover, the genes related with inflammation such as NF-κB, Nlrp3, IL-10/18/1β and Tnf-α were positively or negatively correlated with multiple rhythm-related genes in the central and peripheral organs. In conclusion, TRF, particularly DRF, could modulate rhythm-related genes in the central and peripheral tissues and reduce hepatic expression of inflammation-related genes in gerbils.

2025-01-01·BRAIN BEHAVIOR AND IMMUNITY

18 kDa Translocator protein (TSPO) is upregulated in rat brain after peripheral nerve injury and downregulated by diroximel fumarate

Article

作者: Avery, Thomas D. ; Zagrai, Sever M ; Zagrai, Sever M. ; Avery, Thomas D ; Grieco, Anamaria R. ; Grace, Peter M ; Loggia, Marco L ; Cazuza, Rafael A ; Grieco, Anamaria R ; Abell, Andrew D. ; Abell, Andrew D ; Loggia, Marco L. ; Wey, Hsiao-Ying ; Cazuza, Rafael A. ; Grace, Peter M.

Neuroimmune signaling is a key process underlying neuropathic pain. Clinical studies have demonstrated that 18 kDa translocator protein (TSPO), a putative marker of neuroinflammation, is upregulated in discrete brain regions of patients with chronic pain. However, no preclinical studies have investigated TSPO dynamics in the brain in the context of neuropathic pain and in response to analgesic treatments. We used positron emission tomography-computed tomography (PET-CT) and [¹⁸F]-PBR06 radioligand to measure TSPO levels in the brain across time after chronic constriction injury (CCI) of the sciatic nerve in both male and female rats. Up to 10 weeks post-CCI, TSPO expression was increased in discrete brain regions, including medial prefrontal cortex, somatosensory cortex, insular cortex, anterior cingulate cortex, motor cortex, ventral tegmental area, amygdala, midbrain, pons, medulla, and nucleus accumbens. TSPO was broadly upregulated across these regions at 4 weeks post CCI in males, and 10 weeks in females, though there were regional differences between the sexes. Using immunohistochemistry, we confirmed TSPO expression in these regions. We further demonstrated that TSPO was upregulated principally in microglia in the nucleus accumbens core, and astrocytes and endothelial cells in the nucleus accumbens shell. Finally, we tested whether TSPO upregulation was sensitive to diroximel fumarate, a drug that induces endogenous antioxidants via nuclear factor E2-related factor 2 (Nrf2). Diroximel fumarate alleviated neuropathic pain and reduced TSPO upregulation. Our findings indicate that TSPO is upregulated over the course of neuropathic pain development and is resolved by an antinociceptive intervention in animals with peripheral nerve injury.

2024-11-01·Multiple Sclerosis and Related Disorders

Safety, tolerability, and efficacy of diroximel fumarate in a cohort of Black patients with multiple sclerosis from the phase 3 EVOLVE-MS-1 study

Article

作者: Antezana, Ariel ; Schreiber, Bethany ; Branco, Filipe ; Levin, Seth ; Hunter, Samuel F ; Lindsey, John W. ; Scaramozza, Matthew ; Osborne, Benjamin ; Tian, Zhe ; Hunter, Samuel F. ; Lindsey, John W ; Lewin, James B ; Lewin, James B.

BACKGROUND:

Multiple sclerosis (MS) has not been well studied in racial and ethnic minorities, as these populations are typically underrepresented in clinical trials. Black or African Americans comprise ∼13 % of the US population, yet are represented by as little as 5 % in clinical trials. Differences in disease course and progression have been reported between races and ethnicities, so there is a need to understand the safety and efficacy of disease-modifying therapies (DMTs) in Black patients, to inform evidence-based approaches to treatment in this population.

METHODS:

EVOLVE-MS-1 (NCT0234307) was an open-label, single-arm, phase 3 study assessing the long-term safety, tolerability, and efficacy of diroximel fumarate (DRF) over 96 weeks in adults with relapsing-remitting multiple sclerosis (RRMS). Patients were either newly initiated to DRF or rolled over from completing EVOLVE-MS-2 (NCT03093324). In this post-hoc analysis of the phase 3 EVOLVE-MS-1 study, we evaluate the safety and exploratory efficacy outcomes for DRF in Black and non-Black patient subgroups.

RESULTS:

Of 1057 patients enrolled, 72 (6.8 %) were Black. In Black vs non-Black patients, mean age was 42 vs 43 years and 75 % vs 72 % were female, respectively. In both groups, median (range) duration of DRF exposure was 1.8 (0.0-2.0) years and mean Expanded Disability Status Scale (EDSS) was 2.7. The most common prior DMTs for both Black vs non-Black patients were interferons (47 % vs 37 %) and glatiramer acetate (36 % vs 24 %). DRF treatment was discontinued in 33 (46 %) Black and 224 (23 %) non-Black patients; most common reasons for discontinuation were withdrawal by patient (n = 11, 15.3 %), adverse events (AEs; n = 7, 9.7 %), and lost to follow-up (n = 7, 9.7 %) in Black patients; AEs (8.2 %) and withdrawal by patient (7.0 %) in non-Black patients. AEs were reported in 90 % Black and 89 % non-Black patients; most AEs were mild or moderate in both groups. Gastrointestinal (GI) AEs were reported in 36 % Black and 32 % non-Black patients; no Black patients discontinued due to GI AEs, vs 7 (0.7 %) non-Black patients. The most commonly reported AE was flushing (18 % Black and 28 % non-Black patients). No AEs of lymphopenia were reported in Black patients compared with 13 % of non-Black patients. Mean absolute lymphocyte count declined from baseline to week 48 by 15 % in Black patients and 29 % in non-Black patients, then plateaued and remained above the lower limit of normal (LLN; 0.91 × 10⁹/L). Adjusted annualized relapse rate (95 % confidence interval) was reduced by 78.2 % (54.6 - 89.5; p < 0.0001) in Black patients, from 12 months before to 96 weeks after DRF treatment; similar to 81.7 % (78.5 - 84.5 %; p < 0.0001) reduction in non-Black patients. Mean number of patients free from confirmed disability progression was 93.4 % by week 48, then 86.2 % vs 90.4 % by week 96 in Black vs non-Black patients, respectively.

CONCLUSION:

This study presents the first analysis of safety and efficacy of DRF in Black patients. Relapse rates remained low in Black patients on DRF, consistent with non-Black patients, and there were no new safety signals identified in the Black patient subgroup in EVOLVE-MS-1. Together, these outcomes support DRF as an effective treatment option in Black patients with RRMS.

项与富马酸地罗西美相关的新闻（医药）

2024-11-09

·药事纵横

6家专注于多发性硬化症治疗的biotech

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。多发性硬化症是中枢神经系统（CNS）的一种慢性疾病。作为一种不可预测的疾病，对人的影响不同，一些多发性硬化症患者可能只有轻微的症状，而另一些患者可能会在大脑与身体其他部位之间的交流中断时失去清晰地看、写、说或走路的能力。以下是六家专注于多发性硬化症的生物技术公司，几家公司和研究人员试图通过不同的方法来治疗多发性硬化症，比如BTK抑制剂、CAR-T疗法、双特异性抗体，甚至干细胞疗法。 Biogen 主要多发性硬化候选药物：BIIB091 Biogen以其在神经科学领域的开创性工作而闻名。40多年来，它一直在发现和开发中枢神经系统疾病的治疗方法，包括多发性硬化、肌萎缩侧索硬化（ALS）、阿尔茨海默病、抑郁症、狼疮和脊髓性肌萎缩（SMA）的治疗方法。至于多发性硬化症，该公司已经有几种已获批准的治疗方法，包括Avonex、Plegridy和Vumerity，这些药物都用于治疗多发性硬化症的复发。此外，在其现有的研发过程中，百健正致力于开发下一代伯顿酪氨酸激酶（BTK）抑制剂，称为BIIB091，用于复发性多发性硬化成人患者。目前正处于开发的第二阶段。 BTK是一种非受体酪氨酸激酶，可调节被认为与多发性硬化发病机制有关的B细胞和髓样细胞的发育和信号传导。BIIB091除对B细胞产生作用外，还对髓系细胞中的BTK产生可逆性抑制作用，因此预计BIIB091与仅B细胞疗法相比具有更多的临床益处，并且可以解决共价BTK抑制剂中观察到的耐药性。 Immunic Therapeutics 主要多发性硬化候选药物：Vidofludimus calcium immunictherapeutics正致力于慢性炎症性和自身免疫性疾病的小分子疗法的开发。其主要候选药物是vidofludimus calcium（IMU-838），目前正在开发用于治疗多发性硬化。 IMU-838通过有效激活称为核受体相关1 （Nurr1）的神经保护转录因子发挥作用，Nurr1与直接的神经保护特性相关，并可能增强患者的潜在获益。IMU-838还抑制二氢乳清酸脱氢酶（DHODH），后者是过度活跃的免疫细胞和病毒感染细胞代谢的关键酶。这一双重作用不仅针对炎症和抗病毒过程，而且还解决了多发性硬化潜在的神经退行性方面，使其从现有疗法中脱颖而出，现有疗法虽然能够控制多发性硬化的复发，但不能阻止患者的残疾随着时间的推移而恶化。数项正在进行的多发性硬化试验正在对IMU-838进行测试，包括复发性多发性硬化的两项3期试验和进展性多发性硬化的支持性2期试验。2023年10月，Immunic报告了2期试验的阳性中期数据，因为有生物标志物证据表明，IMU-838的活性超出了之前观察到的抗炎作用。最终，这进一步加强了它的神经保护潜力。此外，在2024年1月，Immunic宣布了高达2.4亿美元的私募。 Kyverna Therapeutics 主要多发性硬化候选药物：KVY-101 Kyverna Therapeutics公司正致力于开发针对b细胞驱动的自身免疫性疾病患者的细胞疗法。这家多发性硬化症公司拥有靶向CD19的自体和异体CAR化合物，该分子在B淋巴细胞的发育、激活和分化中起着重要作用，旨在减少细胞因子释放，消耗B细胞，提高临床耐受性。其主要候选药物KYV-101目前正在一项2期试验中评估用于治疗多发性硬化以及重症肌无力。今年1月，它被美国食品药品监督管理局（FDA）授予快速通道认定，用于治疗难治性进行性多发性硬化患者。此外，Kyverna在2024年2月通过首次公开发行（IPO）获得了.66亿美元的总收益。 Progentos Therapeutics 几个月前，Progentos Therapeutics才成立，获得了6500万美元的A轮融资，用于推进多发性硬化和其他退行性疾病的治疗。在多发性硬化症等疾病中，残疾是由支持轴突功能和生存的脱髓鞘（即髓鞘受损）引起。在这里，免疫系统攻击髓鞘，导致炎症和神经细胞功能受损。正因为如此，Progentos正在开发一种新型小分子，旨在诱导多发性硬化影响的轴突的髓鞘再生。该公司从麻省理工学院（MIT）的子公司Frequency Therapeutics收购了多发性硬化症项目，后者于2023年与RNA编辑公司Korro Bio进行了反向合并。根据Progentos的说法，当涉及到产生和维持髓磷脂的细胞时，它的分子在动物模型中似乎比以前的方法表现更好。从多发性硬化症公司最近的A轮融资中获得的资金将使其能够通过人体概念验证研究来推进其多发性硬化症项目，并扩大其在其他退行性疾病中的研发渠道。 TG Therapeutics 主要多发性硬化候选药物：ublituximab TG Therapeutics专注于利用b细胞生物学的科学进步为患者开发新的治疗方法，特别专注于开发自身免疫性疾病的治疗方法。该公司于2022年12月宣布，FDA已批准其药物BRIUMVI （ublituximab）用于治疗复发型多发性硬化症患者，包括临床孤立综合征，复发缓解性疾病和活动性继发进行性疾病。此外，在2024年9月，TG Therapeutics报告说，经过5年的BRIUMVI治疗，92%的复发性多发性硬化症患者无残疾进展。 Ublituximab是一种单克隆抗体，靶向表达cd20的b细胞上的一个独特表位。当药物与b细胞结合时，会触发一系列免疫反应，包括抗体依赖性细胞毒性[ADCC]和补体依赖性细胞毒性[CDC]，最终导致细胞破坏。此外，阿妥昔单抗被设计为缺乏抗体上正常表达的某些糖分子，因为去除这些糖分子（称为糖工程的过程）已被证明可增强阿妥昔单抗的效力，特别是在ADCC活性方面。作为与Precision BioSciences合作的一部分，TG Therapeutics还在开发一种名为azer-cel的同种异体CAR-T疗法，用于治疗进展型多发性硬化症。Precision BioSciences发现并授权给TG Therapeutics的这一候选药物最近获得了试验性新药（IND）许可，有望于今年晚些时候开始临床试验。 Zenas BioPharma 主要多发性硬化候选药物：Obexelimab Zenas BioPharma专注于基于免疫学的疗法，目前正致力于开发其主要候选药物obexelimab，用于治疗各种免疫学和炎症疾病，包括多发性硬化。 Obexelimab是一种双功能单克隆抗体，旨在通过与广泛存在于B细胞谱系中的蛋白CD19和FcγRIIb结合来耗竭B细胞。根据该公司的说法，这些靶点的共同参与导致了B细胞活性的抑制。 Zenas BioPharma目前正在一项2期试验中纳入患者，以评估obexelimab治疗复发性多发性硬化患者的疗效和安全性。该公司最近也筹集了可观的资金。2024年5月，该公司宣布在C轮融资中获得2亿美元，9月还宣布了2.25亿美元的IPO。这两轮融资的收益将帮助该公司进一步推进obexelimab的研发。参考资料：各公司官网 -END- 2025CMC-CHINA药博会 • 展位火热预定中！

临床2期细胞疗法免疫疗法临床1期临床3期

2024-10-31

·Insight数据库

渤健 2024Q3：仑卡奈单抗卖了 6700 万美元，环比增长 66%

10 月 30 日，渤健发布 2024Q3 业绩，前三季度总营收 72.21 亿美元（-3%），其中产品收入 53.81 亿美元；第三季度营收 24.66 亿美元（-2.5%）。其中，用于阿尔兹海默病的 LEQEMBI（仑卡奈单抗）第三季度全球销售额约 6700 万美元，较上一季度增长 66%，其中美国市场销售额约 3900 万美元。截图来源：渤健财报仑卡奈单抗是全球首个获 FDA 完全批准的 AD 新药，今年三季度取得的进展如下： • 2024 年 7 月，卫材公布了 LEQEMBI 的 CLARITY AD 研究开放标签扩展的新临床数据，表明连续三年的 LEQEMBI 治疗减少了临床衰退，对早期阿尔茨海默病患者有临床意义的益处。 • 2024 年 6 月，FDA 接受了审查 LEQEMBI 每月静脉维持剂量治疗早期阿尔茨海默病的补充 BLA，PDUFA 行动日期定为 2025 年 1 月 25 日。 • 2024 年 5 月，在获得 FDA 快速通道资格后，卫材开始向 FDA 滚动提交 LEQEMBI 皮下自动注射的 BLA，用于每周维持剂量。多发性硬化症领域第三季度实现营收 10.54 亿美元同比 -9%。（主要产品包括 TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI, 和 FAMPYRA）罕见病领域实现营收 4.95 亿美元，同比+10%。（主要产品包括SPINRAZA, SKYCLARYS 和 QALSODY）产后抑郁药物 ZURZUVAE（舒拉诺龙）第三季度收入约为 2200 万美元。截图来源：渤健财报渤健提高了 2024 年全年财务指引：截图来源：渤健财报维持 2024 年全年总收入较 2023 年全年下降个位数百分比的预期，核心药品收入预计与 2023 年全年大致持平；与 2023 年全年相比，目前预计营业收入将以较高的百分比增长，营业利润率将保持中等个位数的增长。重点产品前三季度销售额：截图来源：渤健财报封面来源：企业 Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：vvy PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

财报

2024-10-24

·PRNewswire

Alkermes plc Reports Third Quarter 2024 Financial Results

— Third Quarter Revenues of $378.1 Million — — Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year — — GAAP Net Income from Continuing Operations of $92.8 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.56 — — Company Reiterates 2024 Financial Expectations — DUBLIN, Oct. 24, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the third quarter of 2024. "Our third quarter financial results reflect strong year-over-year growth of our portfolio of proprietary commercial products and position us well to meet our strategic, operational and financial priorities for the year. Looking ahead, we believe growing our proprietary commercial products and advancing our pipeline, particularly ALKS 2680, our novel, investigational, orexin 2 receptor agonist, and additional orexin development candidates, will serve as the key drivers of shareholder value. We plan to manage the business to deliver significant profitability and cash flow while investing in these strategic initiatives," said Richard Pops, Chief Executive Officer of Alkermes. "2025 has the potential to be a transformational year for Alkermes as we expect to complete the ongoing phase 2 studies in narcolepsy type 1 and narcolepsy type 2, and prepare for potential registrational studies for ALKS 2680. With the potential to transform the treatment of hypersomnolence disorders, and with broad potential applicability across other symptomatic domains, orexin 2 receptor agonists represent one of the most exciting new therapeutic categories in development and we believe a significant opportunity for Alkermes and our shareholders." Key Financial Highlights *As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the nine months ended September 30, 2023 included approximately $195.4 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products that would ordinarily have been recognized in prior periods. Revenue Highlights LYBALVI Revenues for the quarter were $74.7 million. Revenues and total prescriptions for the quarter grew 47% and 37%, respectively, compared to the third quarter of 2023. ARISTADAi Revenues for the quarter were $84.7 million. VIVITROL Revenues for the quarter were $113.7 million. Revenues for the quarter grew 14% compared to the third quarter of 2023, driven by the alcohol dependence indication. Manufacturing & Royalty Revenues Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $58.4 million. VUMERITY® manufacturing and royalty revenues for the quarter were $32.6 million. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. Balance Sheet At Sept. 30, 2024, the company recorded cash, cash equivalents and total investments of $927.8 million, compared to $962.5 million at June 30, 2024. The company's total debt outstanding as of Sept. 30, 2024 was $288.8 million. Share Repurchase Program During the third quarter of 2024, the company repurchased approximately 4.4 million of the company's ordinary shares under the share repurchase program authorized in February 2024, at a total purchase price of $115.6 million. As of Sept. 30, 2024, the company had $200 million (exclusive of any fees, commissions or other related expenses) remaining under the program. Financial Expectations for 2024 Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024. Recent Events In October 2024, the company hosted an investor event to review its portfolio of orexin 2 receptor agonists and development strategy. The company presented data from its ALKS 2680 phase 1b study in patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), and discussed the study design for its ongoing phase 2 studies in NT1 and NT2. The company also announced its plans to initiate a phase 2 study in patients with IH in 2025. In September 2024, the company presented positive clinical data from its phase 1b study of ALKS 2680 in patients with NT2 and IH at the European Sleep Research Society's 27th Congress, Sleep Europe 2024. In August 2024, the company announced the initiation of its Vibrance-2 phase 2 study of ALKS 2680 in patients with NT2. In August 2024, the company published its latest Corporate Responsibility Report, which details how the company integrates environmental, social and governance considerations into its business. A copy of the report is available on the Responsibility section of Alkermes' website. Notes and Explanations 1. The company determined that upon the separation of its oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and nine months ended Sept. 30, 2023. Conference Call Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Thursday, Oct. 24, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at . The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website. About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes' website at . Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense. The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of the company's liquidity. A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company’s expectations concerning its future financial and operating performance, business plans or prospects, including drivers of shareholder value and profitability; and the company’s expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, ALKS 2680 and the company’s other orexin portfolio candidates. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to achieve its financial expectations, including those related to profitability; the unfavorable outcome of arbitration or litigation, including so-called “Paragraph IV” litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company’s products or products using the company’s proprietary technologies; clinical development activities may not be completed on time or at all; the results of the company’s development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to government payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2023 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise. SOURCE Alkermes plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

财报临床1期临床2期临床结果

100 项与富马酸地罗西美相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11154	富马酸地罗西美	L03	DB14783

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
复发-缓解型多发性硬化	欧盟	Biogen Netherlands BV	2021-11-15
复发-缓解型多发性硬化	冰岛	Biogen Netherlands BV	2021-11-15
复发-缓解型多发性硬化	列支敦士登	Biogen Netherlands BV	2021-11-15
复发-缓解型多发性硬化	挪威	Biogen Netherlands BV	2021-11-15
多发性硬化症	瑞士	Biogen, Inc.	2021-09-20
复发性多发性硬化	美国	Biogen, Inc.	2019-10-29

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
GM1神经节苷脂贮积病	临床3期	美国	Alkermes, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	美国	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	比利时	Alkermes, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	比利时	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	保加利亚	Alkermes, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	保加利亚	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	加拿大	Alkermes, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	加拿大	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	德国	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	德国	Alkermes, Inc.	2015-12-10

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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


NCT02634307 (EVOLVE-MS-1, Pubmed)	临床3期	复发-缓解型多发性硬化 lymphopenia \| ALC decline	-	Diroximel Fumarate	積選鏇壓衊獵餘範鹽窪(鑰襯鹽廠衊鏇廠鑰鑰齋) = 築艱鬱齋夢蓋鑰衊淵願鬱壓積窪蓋廠範選膚積 (鹽網鏇鑰鹹糧鏇願顧構 )	积极	2024-06-27
NCT02634307 (EVOLVE-MS-1, Pubmed)	临床3期	复发-缓解型多发性硬化	1,057	Diroximel fumarate	夢蓋糧淵鏇網醖衊築構(觸蓋淵壓襯壓壓觸簾繭) = 積憲餘醖築鑰製窪蓋遞築觸齋壓夢選廠廠選簾 (憲繭築鏇齋餘壓鹹鏇選 )	积极	2024-06-15
				Dimethyl fumarate	夢蓋糧淵鏇網醖衊築構(觸蓋淵壓襯壓壓觸簾繭) = 鹹憲獵網繭製鹽簾製鏇築觸齋壓夢選廠廠選簾 (憲繭築鏇齋餘壓鹹鏇選 )
ACTRIMS2024	N/A	多发性硬化症	-	Fumarates (Black)	夢觸艱齋蓋壓襯範鬱選(齋廠簾齋繭觸蓋繭夢窪) = 餘鏇餘鹽鹽鑰遞艱鑰築築膚觸鏇鹽艱鑰鑰衊顧 (齋淵壓襯觸鏇蓋鏇願願 ) 更多	-	2024-03-01
				Fumarates (Hispanic)	夢觸艱齋蓋壓襯範鬱選(齋廠簾齋繭觸蓋繭夢窪) = 蓋築淵鏇選製鹽築觸襯築膚觸鏇鹽艱鑰鑰衊顧 (齋淵壓襯觸鏇蓋鏇願願 ) 更多
ECTRIMS2023	N/A	多发性硬化症	29	Dimethyl Fumarate (DMF)	淵繭夢衊衊淵窪製淵積(範選獵構壓壓壓顧網淵) = The incidence of lymphopenia (ALC <910) in this cohort of PwMS who transitioned from DMF to DRF increased from 24% at baseline to 52% 12 months after treatment change. 衊艱壓獵願觸獵顧築繭 (壓鹹夢糧選齋鹽積鬱廠 ) 更多	积极	2023-10-01
ECTRIMS2023	N/A	神经炎症	-	Diroximel fumarate (DRF)	淵繭餘觸積糧艱獵鹹顧(淵積選鬱觸夢繭繭簾鏇) = significantly reduced IFNγ secretion in splenocytes isolated from DRF treated mice 齋淵壓餘淵網鹹廠獵膚 (憲選獵繭淵鹹製獵範糧 ) 更多	积极	2023-09-30
				Vehicle (methocel)
ECTRIMS2023	N/A	淋巴细胞减少	72	Dimethyl Fumarate (DMF)	膚鑰觸鬱淵遞選壓簾選(憲壓衊網蓋淵夢餘衊願) = 獵窪積鹽積蓋簾齋衊顧齋壓襯齋鑰窪鹽獵衊窪 (觸蓋顧願鬱獵構積憲廠 )	-	2023-09-30
				Diroximel Fumarate (DRF)	膚鑰觸鬱淵遞選壓簾選(憲壓衊網蓋淵夢餘衊願) = 鏇襯鑰齋衊遞膚壓艱獵齋壓襯齋鑰窪鹽獵衊窪 (觸蓋顧願鬱獵構積憲廠 )
SUNBEAM (RPC01-301), RADIANCE phase 3 (RPC01-201B), EVOLVE-MS-1 (ACTRIMS2023)	临床3期	复发-缓解型多发性硬化	-	Ozanimod 1.0 mg	壓願繭鏇窪範顧願鹽鑰(鬱積糧艱製鏇蓋遞範糧): risk ratio = 0.924 (95% CI, 0.646 ~ 1.324) 更多	积极	2023-05-30
				Diroximel fumarate 462 mg
ACTRIMS2023	N/A	多发性硬化症	11	Diroximel Fumarate	艱網遞構鹽廠蓋鹹艱襯(簾齋顧窪壓顧壓構遞網) = 鹽鏇夢遞簾鏇鏇製鑰夢願獵襯衊壓觸餘憲艱鏇 (膚鏇襯製遞構淵簾遞簾 ) 更多	积极	2023-05-30
				Dimethyl Fumarate	艱網遞構鹽廠蓋鹹艱襯(簾齋顧窪壓顧壓構遞網) = 遞製衊蓋鹹鏇觸夢艱糧願獵襯衊壓觸餘憲艱鏇 (膚鏇襯製遞構淵簾遞簾 ) 更多
EVOLVE-MS-1, OPTIMUM (Pubmed)	临床3期	复发性多发性硬化	-	Diroximel fumarate	築築餘觸壓範積構醖齋(繭夢鏇願糧積鑰築艱襯) = 蓋鏇遞齋醖繭糧構顧觸壓壓鏇願蓋遞顧觸製遞 (獵簾艱夢醖膚蓋餘餘鏇 )	-	2023-05-08
NCT02634307 (EVOLVE-MS-1, AAN2023)	临床3期	复发-缓解型多发性硬化	239	Diroximel Fumarate	鹽艱蓋壓簾壓範壓鹽顧(範衊簾醖鹽遞鹽選範築) = 23 (9.6%) patients discontinued DRF due to adverse events 膚壓築鏇糧製齋艱鬱淵 (夢廠選衊製鏇構構網醖 ) 更多	积极	2023-04-25