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Biogen and Ionis Announce Topline Phase 1/2 Study Results of Investigational Drug in Amyotrophic Lateral Sclerosis
Newsfilter· 2024-05-16 19:30
Development of BIIB105, an investigational antisense oligonucleotide for amyotrophic lateral sclerosis (ALS), will be discontinued based on data from the Phase 1/2 ALSpire studyBiogen and Ionis continue their long-standing commitment to developing therapies for ALS given the devastating impact of this progressive, fatal neurodegenerative condition CAMBRIDGE, Mass. and CARLSBAD, Calif., May 16, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) and Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) announced the deci ...
Ionis and Biogen Announce Topline Phase 1/2 Study Results of Investigational Drug in Amyotrophic Lateral Sclerosis
prnewswire.com· 2024-05-16 19:30
Development of BIIB105, an investigational antisense oligonucleotide for amyotrophic lateral sclerosis (ALS), will be discontinued based on data from the Phase 1/2 ALSpire studyBiogen and Ionis continue their long-standing commitment to developing therapies for ALS given the devastating impact of this progressive, fatal neurodegenerative conditionCARLSBAD, Calif. and CAMBRIDGE, Mass., May 16, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Biogen Inc. (Nasdaq: BIIB) announced the decisio ...
Biogen and Ionis Announce Topline Phase 1/2 Study Results of Investigational Drug in Amyotrophic Lateral Sclerosis
globenewswire.com· 2024-05-16 19:30
Development of BIIB105, an investigational antisense oligonucleotide for amyotrophic lateral sclerosis (ALS), will be discontinued based on data from the Phase 1/2 ALSpire studyBiogen and Ionis continue their long-standing commitment to developing therapies for ALS given the devastating impact of this progressive, fatal neurodegenerative condition CAMBRIDGE, Mass. and CARLSBAD, Calif., May 16, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced the de ...
Biogen (BIIB) Partner Begins Filing for Leqembi SC Autoinjector
Zacks Investment Research· 2024-05-16 01:15
Biogen Inc.’s (BIIB) Japan-based partner, Eisai., announced that it has initiated the rolling submission of a biologics license application (“BLA”) to the FDA seeking approval for Leqembi (lecanemab) subcutaneous (SC) autoinjector as a weekly maintenance dosing for the treatment of early Alzheimer’s disease (AD).Leqembi gained full approval from the FDA for early Alzheimer’s disease in the United States and broad reimbursement from the Centers for Medicare & Medicaid Services in July 2023. Leqembi is also a ...
Eisai Initiates Rolling Biologics License Application to US FDA for LEQEMBI® (lecanemab-irmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status
Newsfilter· 2024-05-15 07:33
TOKYO and CAMBRIDGE, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen"))) announced today that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dosing after i ...
Eisai Initiates Rolling Biologics License Application to US FDA for LEQEMBI® (lecanemab-irmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status
Prnewswire· 2024-05-15 07:30
TOKYO and CAMBRIDGE, Mass., May 14, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dosing after it was ...
Biogen Reports Progress on Corporate Responsibility Priorities
Newsfilter· 2024-05-02 19:30
Efforts focused on four areas: access and health equity, workforce and DE&I, community impact and the environment CAMBRIDGE, Mass., May 02, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced publication of its 2023 Corporate Responsibility Report detailing progress on the company's commitment to making responsible business decisions in the best interests of all its stakeholders. "As we reflect on the past year and set our sights on the path ahead, I am truly inspired by the progress we have ...
7 Retirement Stocks to Buy at a 52-Week Low in April
InvestorPlace· 2024-04-29 22:03
One of the best ways to keep your portfolio safe while generating consistent income is in safe, dividend-paying retirement stocks at 52-week lows. It’s even better if you’re buying into a reputable company that’s paid out dividends for years, and is on sale.Look at American States Water (NYSE:AWR), for example. Over the last few months, the water and electric utility stock plunged to about $66 a share from $85 in December. All thanks to an increase in operating costs, interest expenses, and higher interest ...
Why Biogen Stock Leaped Nearly 5% Higher Today
The Motley Fool· 2024-04-25 06:18
Biogen财报表现 - Biogen在2024年首次季度财报中表现出色,收入高于预期,股价上涨了近5%[1] - 尽管产品销售下滑,但Biogen的非GAAP调整净收入增长了8%,达到5.35亿美元,每股3.67美元[4] Leqembi销售情况 - Leqembi是Biogen的一大亮点,作为首个FDA批准的能够减缓阿尔茨海默病进展的药物,销售额达到约1900万美元,几乎是去年的两倍[6] 公司指导方针确认 - 公司确认了2024年整体指导方针,预计调整后净利润为每股15至16美元,营收将以低至中单位数百分比的速度下降[7]
Biogen(BIIB) - 2024 Q1 - Quarterly Report
2024-04-25 04:15
总收入变化 - 公司在2024年第一季度总收入减少了7.0%,达到了172.5亿美元[227] - 2024年第一季度总收入为229.05亿美元,较去年同期下降7.0%[241] 产品收入变化 - 多个TECFIDERA仿制品进入市场导致TECFIDERA需求下降,影响了公司的MS产品收入[227] - 稀有疾病产品收入下降,主要是由于SPINRAZA在全球其他地区的收入受到发货时间的影响[228] - 公司的MS产品收入减少了4.4%,稀有疾病产品收入也减少了4.4%[229] 成本和费用变化 - 成本和费用方面,销售成本的减少主要是由于合同制造收入减少和闲置产能费用降低[230] - 研发支出的减少主要是由于2024年实施的成本削减措施和与ADUHELM相关的临床试验结项成本[231] - 成本支出方面,销售、一般和行政费用减少了1.99亿美元,降低了9.8%[232] 新产品动态 - LEQEMBI在美国完成了针对早期阿尔茨海默病的月度静脉维持剂补充BLA提交[233] - LEQEMBI在中国获得批准,预计将于2024年推出[234] - CHMP推荐了tofersen的MAA,用于治疗ALS成年患者,这将是欧盟批准的首个针对ALS基因原因的治疗[235] - SKYCLARYS在欧盟获得批准,用于治疗16岁及以上的成人和青少年FA患者[236] 合同制造收入变化 - 2024年第一季度,合同制造收入为1.522亿美元,较2023年同期的3.069亿美元下降了50.5%[262] - 合同制造收入下降主要是由于2023年批量生产的时机导致了较高的销量,而2023年第一季度开始认可LEQEMBI相关批次[262] - 2024年第一季度,合同制造收入占总产品收入的比例为33.2%,较去年同期的31.4%有所增加[266] 合同调整和折扣变化 - 合同调整主要涉及美国的医疗补贴和管理折扣,药房折扣,VA,340B折扣,特殊药房计划费用和其他政府折扣或适用津贴[267] - 2024年第一季度,相比于2023年同期,合同调整增加主要是由于美国的Medicaid和政府折扣增加,部分抵消了全球其他地区的政府折扣减少[268] - 折扣主要包括贸易条款折扣和批发商激励[269] - 2024年第一季度,相比于2023年同期,折扣增加主要是由于生物仿制药的购买和销量折扣增加[270] - 2024年第一季度,相比于2023年同期,退货增加主要是由于美国退货率增加[271] 公司财务及合同情况 - 公司于2023年9月收购Reata,签署了15亿美元的贷款协议,从中提取10亿美元用于收购[326] - 公司授权2020年股票回购计划,最多回购50亿美元的普通股,截至2024年3月31日,尚有21亿美元可用于回购[330] - 公司的合同义务主要包括非取消的经营租赁、长期债务义务和定义的利益以及其他采购义务[331]