DUBLIN, Sept. 25, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that it will host an investor event for financial analysts and institutional investors on Wednesday, Oct. 9, 2024 starting at 10:00 a.m. EDT in Waltham, Mass. Members of Alkermes' Research & Development team will review the company's orexin portfolio and development strategy. The event will also feature a clinician and thought leader panel discussion. A question and answer session will follow the presentations.The event will ...

̶  Data From Narcolepsy Type 2 Cohort of ALKS 2680 Phase 1b Study to be Presented in Oral Presentation  ̶̶  Data From Idiopathic Hypersomnia Cohort of ALKS 2680 Phase 1b Study Accepted for Poster Presentation  ̶DUBLIN, Sept. 23, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced plans to present clinical data from its phase 1b study of ALKS 2680 in patients with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) at the European Sleep Research Society's (ESRS) 27th Congress, Sleep Europe 2 ...

—  Competitive Grant Program to Offer Individual Grants of Up to $100,000 per Project  ——  Application Period to Run From Sept. 20, 2024 Through Nov. 30, 2024  —DUBLIN, Sept. 13, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that it will begin accepting applications for its annual Alkermes Pathways Research Awards® program on Friday, Sept. 20, 2024. Now in its seventh year, this competitive grant program is designed to support the next generation of researchers working on the front lines ...

DUBLIN, Aug. 28, 2024  /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that management will participate in a fireside chat presentation at the Morgan Stanley 22nd Annual Global Healthcare Conference on Wednesday, Sept. 4, 2024 at 2:35 p.m. EDT (7:35 p.m. BST). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.About Alkermes plcAlkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of n ...

Alkermes plc (ALKS) announced the initiation of the phase II Vibrance-2 study, evaluating its novel, investigational, oral orexin 2 receptor agonist ALKS 2680 in adults with narcolepsy type 2 (NT2).The double-blind, placebo-controlled study will evaluate the safety and efficacy of ALKS 2680 as compared to placebo in adults with NT2. The primary endpoint of the Vibrance-2 study will check whether treatment with ALKS 2680 leads to a greater decrease in sleepiness versus placebo, as measured by the change in m ...

文章核心观点 - 公司宣布启动Vibrance-2临床试验 评估ALKS 2680治疗2型narcolepsy的安全性和有效性 [1][2] - ALKS 2680是公司开发的一种新型口服选择性orexin 2受体激动剂 作为治疗narcolepsy的每日一次用药 [6] - 该药物正在进行2期临床试验 包括Vibrance-1和Vibrance-2 分别评估在1型和2型narcolepsy患者中的疗效和安全性 [5][8] 根据目录分别总结 关于ALKS 2680 - ALKS 2680是一种新型口服选择性orexin 2受体激动剂 正在开发用于治疗narcolepsy [6] - Orexin是调节清醒状态的关键神经肽 靶向orexin系统可能有助于改善各种嗜睡障碍的日间嗜睡症状 [6] - ALKS 2680曾在1期临床试验中评估过 现正在2期Vibrance-1和Vibrance-2试验中进一步评估 [6] 关于narcolepsy - Narcolepsy是一种慢性神经系统疾病 主要症状是过度日间嗜睡 还可能伴有其他症状如睡眠麻痹和睡眠相关幻觉 [7] - 1型narcolepsy是由于丢失分泌orexin的神经元导致 常伴有突发性肌肉无力发作 [7] - 2型narcolepsy的病因机制尚未完全阐明 但orexin通路可能起重要作用 [7] - Narcolepsy在美国约有20万成人患者 男女发病率相当 [7] 关于Vibrance临床试验 - Vibrance-2是一项2期随机双盲剂量范围探索性安慰剂对照试验 评估ALKS 2680在2型narcolepsy患者中的安全性和有效性 [3] - 试验将随机给予3个剂量的ALKS 2680或安慰剂 主要评估指标为维持清醒测试的睡眠潜伏期变化 [3] - Vibrance-1试验正在评估ALKS 2680在1型narcolepsy患者中的疗效和安全性 [5]

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Taking full advantage of the stock market and investing with confidence are common goals for new and old investors, and Zacks Premium offers many different ways to do both.The popular research service can help you become a smarter, more self-assured investor, giving you access to daily updates of the Zacks Rank and Zacks Industry Rank, the Zacks #1 Rank List, Equity Research reports, and Premium stock screens.Zacks Premium includes access to the Zacks Style Scores as well.What are the Zacks Style Scores?The ...

Alkermes plc (ALKS) reported adjusted earnings from continuing operations of 72 cents per share for second-quarter 2024, which missed the Zacks Consensus Estimate of 73 cents. The company had reported adjusted earnings of 78 cents per share in the year-ago quarter.ALKS’ total revenues of $399.1 million declined 35.3% from the year-ago quarter’s level owing to decreased manufacturing and royalty revenues. The top line, however, beat the Zacks Consensus Estimate of $394 million.Quarter in DetailAlkermes deriv ...

财务数据和关键指标变化 - 公司在第二季度实现总收入3.991亿美元,同比增长16%,主要由于自有商品组合的强劲表现 [10] - VIVITROL净销售额为1.119亿美元,同比增长10% [11] - ARISTADA产品系列净销售额为8600万美元,与去年同期相比保持稳定 [11] - LYBALVI净销售额为7140万美元,同比增长52% [11] - 制造和特许权使用费收入为1.299亿美元,其中INVEGA系列产品收入为7870万美元,VUMERITY收入为3520万美元 [12][13] - 毛利率为84.6%,研发费用为5960万美元,销售及管理费用为1.681亿美元,均同比有所下降 [14][15] - 公司实现GAAP净利润9470万美元,非GAAP净利润1.234亿美元,EBITDA1.186亿美元 [16] - 公司现金及投资总额为9.625亿美元,二季度完成了对爱尔兰Athlone制造工厂的出售,获得约9100万美元现金 [17][18] 各条业务线数据和关键指标变化 - VIVITROL主要由酒精依赖适应症带动,占其75%以上的销量 [26] - ARISTADA新增处方有所增长,但整体长效抗精神病药市场有所疲软 [25] - LYBALVI处方量环比增长12%,新增处方量增长17%,处方医生数量同比增长23% [51][52][53] 各个市场数据和关键指标变化 - 公司密切关注Medicaid退保情况,目前未发现对公司产品组合产生重大影响 [63][64] - LYBALVI在商业和Medicare Part D计划的覆盖范围进一步扩大,约5000万人获得更好的准入 [23][24] 公司战略和发展方向及行业竞争 - 公司正在积极评估并购机会,既可以增加收益,也可以补充管线 [43][45] - 公司正在加快推进ALKS 2680的临床开发,计划在2型和1型narcolepsy以及特发性嗜睡症等适应症开展临床试验 [30][31][32][35][37] - 公司认为ALKS 2680作为一种选择性的Orexin-2受体激动剂,有望成为治疗narcolepsy和其他需求醒觉的神经系统疾病的新型治疗方案 [59][60][61] - 公司认为Orexin受体激动剂领域的竞争格局将相对集中,因为分子优化和适应症覆盖是关键 [89][90] 管理层对经营环境和未来前景的评论 - 公司对2024年的财务目标保持信心,并将继续保持高效的运营和执行力 [19][28] - 管理层认为公司已成功转型为一家专注于神经科学的增长型生物制药公司,未来将继续推进商业产品组合和管线的发展 [29] 其他重要信息 - 公司在二季度回购了约350万股,总金额为8470万美元 [18] - 公司计划在未来进一步加大股票回购力度,以提升股东价值 [39] 问答环节重要的提问和回答 问题1 **Umer Raffat 提问** 公司对并购的优先考虑是增加收益还是补充管线 [43][45] **Richard Pops 回答** 公司对并购的优先考虑是既可以增加收益,也可以补充管线 [45] 问题2 **Charles Duncan 提问** ALKS 2680 Vibrance-1临床试验的预计时间进度 [48][50] **Richard Pops 回答** Vibrance-1试验正在启动中,目前还无法给出具体的时间进度,公司会在后续提供更多信息 [50] 问题3 **Chris Shibutani 提问** 公司是否会优先推进2型narcolepsy适应症,因为目前还没有其他公司在开发 [57] **Richard Pops 回答** 公司认为narcolepsy包括1型和2型都是重要的适应症,并计划针对两种类型开展临床试验,以全面覆盖这一疾病领域 [59][60][61]