The U.S. Food and Drug Administration has declined to approve a higher dose version of Biogen's drug for a rare genetic disorder that causes progressive muscle weakness, dealing a setback to the compa... ...

CAMBRIDGE, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Company’s supplemental New Drug Application (sNDA) for the high dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA). The FDA letter requested an update to the technical information be included in the Chemistry Manufacturing and Controls (CMC) module of the sNDA. The letter did not cite any de ...

Looking into the current session, Biogen Inc. BIIB shares are trading at $145.60, after a 0.50% spike. Moreover, over the past month, the stock increased by 4.28%, but in the past year, fell by 27.23%. Shareholders might be interested in knowing whether the stock is undervalued, even if the company is performing up to par in the current session. Biogen P/E Compared to CompetitorsThe P/E ratio is used by long-term shareholders to assess the company's market performance against aggregate market data, historic ...

欧洲监管批准 - 欧洲委员会批准Zurzuvae用于治疗成人产后抑郁症 成为欧盟首个且唯一获批的产后抑郁症治疗药物[1] - 该口服药物需每日服用一次 疗程为14天[1] - 美国FDA已于2023年8月批准该药物用于类似适应症[1] 临床试验数据 - 批准基于III期SKYLARK研究结果 该研究达到主要终点和所有关键次要终点[2] - 数据显示与安慰剂相比 Zurzuvae最早在第3天就显现抑郁症状快速缓解效果 并持续至第45天[2] - 产后抑郁症是欧洲孕产妇死亡的主要原因 估计该地区20%的近期妊娠女性出现产后抑郁症症状[2] 商业化表现 - Zurzuvae在美国自2023年12月商业化上市以来销售表现强劲[6] - 2025年第二季度该药物销售额达4640万美元 环比增长68% 超出公司内部预期[6][7] - 在美国市场 Biogen与Supernus Pharmaceuticals平均分摊商业化利润和亏损 在非美国市场（除日本、台湾和韩国）Biogen记录产品销售额并向Supernus支付特许权使用费[5] 产品管线地位 - Zurzuvae是Biogen四个新产品上市之一 其他包括阿尔茨海默病药物Leqembi、弗里德赖希共济失调药物Skyclarys和ALS药物Qalsody[8] - 这些新产品有望推动公司长期增长复苏[8] 公司股价表现 - 今年以来Biogen股价下跌5% 同期行业增长3%[3] 行业比较标的 - ANI Pharmaceuticals2025年每股收益预期从653美元上调至725美元 2026年从707美元上调至774美元 年内股价上涨72%[10] - ANI Pharmaceuticals过去四个季度每股收益均超预期 平均超出22.66%[11] - CorMedix2025年每股收益预期从110美元上调至152美元 2026年从146美元上调至212美元 年内股价上涨37%[11] - CorMedix过去四个季度每股收益均超预期 平均超出34.85%[11]

交易完成后，加入百健的Alcyone员工将被整合到产品交付解决方案团队，增强百健在药物-设备组合产 品方面的能力。 目前，ThecaFlex DRx系统正与Spinraza (nusinersen)联合用于脊髓性肌萎缩症患者的临床测试，这项研 究将为百健未来实验性疗法的开发提供重要指导。 百健将推动ThecaFlex DRx的端到端研发和商业化，该产品是一种用于鞘内输送反义寡核苷酸(ASO)的 实验性植入式设备。ThecaFlex DRx有望为神经系统疾病患者提供一种全新的便捷给药方式。 智通财经APP获悉，百健(BIIB.US)周四宣布，同意收购总部位于马萨诸塞州的Alcyone Therapeutics，此 举将拓展其关键产品及管线候选药物的药物递送解决方案组合。该交易包括一笔8500万美元的预付款， 以及与ThecaFlex DRx的开发和监管批准相关的额外里程碑付款。这笔交易使百健获得ThecaFlex DRx的 全部权利。 ...

Biogen (NASDAQ:BIIB) said that it has agreed to acquire Alcyone Therapeutics, a company based in Massachusetts. The deal involves an upfront payment of $85M, along with additional milestone payments tied to the development and regulatory approval of ThecaFlex DRx, which is associated with ...

Biogen to drive end-to-end development and commercialization of ThecaFlex DRx™, an investigational implantable device for intrathecal delivery of antisense oligonucleotides (ASOs)ThecaFlex DRx™ has the potential to be a new, convenient way to administer medicines to patients living with neurological disorders. CAMBRIDGE, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the company has entered into a definitive agreement to acquire Massachusetts-based Alcyone Therapeutics. As pa ...

Postpartum depression is a leading cause of maternal mortality in Europe1-2, and is one of the most common medical conditions associated with pregnancy3-5; up to 20% of women experience postpartum depressive symptoms6-11The approval of this new therapeutic approach introduces an oral, 14-day treatment specifically indicated for PPDThe EC approval of ZURZUVAE is based on the SKYLARK study, which demonstrated rapid relief from depressive symptoms as early as day 3 and sustained through day 45 compared to plac ...

Biogen Inc. (NASDAQ:BIIB) is one of the best drug stocks to buy right now. In a report released on September 12, Sumant Kulkarni from Canaccord Genuity reiterated a Buy rating on Biogen Inc. (NASDAQ:BIIB) and set a price target of $220.00. Biogen Inc. (BIIB): Among Small-Cap Healthcare Stocks Hedge Funds is Buying Biogen Inc. (NASDAQ:BIIB) reported total revenue of $2.6 billion in its fiscal Q2 2025 results, up 7% year-over-year. GAAP diluted EPS for the quarter reached $4.33, up 8% year-over-year. Non-G ...

投资评级与目标价 - H C Wainwright维持买入评级 目标股价194美元 [1] - 机构看好公司狼疮治疗管线前景 [1][2] 核心产品管线进展 - 狼疮治疗药物litifilimab和dapirolizumab pegol为晚期核心资产 具有独特作用机制且竞争极小 [2] - dapirolizumab pegol三期试验结果积极 确认性试验PHOENYCS-FLY预计2027年或2028年初完成 [2] - 阿尔茨海默病治疗药物LEQEMBI IQLIK已提交FDA审批 并获得快速通道资格 [3] 公司业务定位 - 全球生物技术公司 专注于神经学 神经精神病学 专业免疫学和罕见疾病领域 [4] - 开发多发性硬化症等突破性疗法 以首创型治疗方案著称 [4]