Biogen (BIIB) , due to report second-quarter 2024 results on Aug 1, suffered a setback recently. Biogen and its Japanese partner Eisai on Friday announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a negative opinion regarding marketing approval for their anti-amyloid beta therapy, Leqembi (lecanemab) for early Alzheimer’s disease in Europe.  The CHMP’s negative opinion was reportedly due to a brain swelling side effect called amyloid-related im ...

文章核心观点 - 公司过去依靠多发性硬化症(MS)治疗药物维持增长,但随着老产品专利到期,增长停滞,2019年年收入达到峰值后下降超过45%至98亿美元[2] - 公司为了提振增长,转向阿尔茨海默病治疗领域,与合作伙伴艾赛制药获批了新药Leqembi,但最近在欧洲遭到监管机构否决[3] - 尽管欧洲监管机构否决了Leqembi,但美国市场仍被认为是该药物最大的市场,预计2023-2028年将贡献77亿美元收入,占总收入的60%左右[10] - 公司表示Leqembi的推广存在挑战,但一季度销售额已达1900万美元,较去年四季度增长近3倍,患者人数也增加了2.5倍以上[12] 根据相关目录分别进行总结 公司发展历程 - 公司过去依靠多发性硬化症(MS)治疗药物维持增长,但随着老产品专利到期,增长停滞,2019年年收入达到峰值后下降超过45%至98亿美元[2] - 为了提振增长,公司转向阿尔茨海默病治疗领域,与合作伙伴艾赛制药获批了新药Leqembi[3] Leqembi新药进展 - 公司与艾赛制药获批Leqembi,这是首个获批能够延缓认知功能下降的阿尔茨海默病治疗药物[6] - 但欧洲监管机构认为Leqembi的风险大于潜在收益,拒绝批准该药物[7][8] - 公司计划寻求重新审查,但这类请求获得成功的概率较低,约39%[9] 对公司的影响 - 即使欧洲监管机构否决Leqembi,美国市场仍是该药物最大市场,预计2023-2028年将贡献77亿美元收入,占总收入的60%左右[10] - 公司表示Leqembi的推广存在挑战,但一季度销售额已达1900万美元,较去年四季度增长近3倍,患者人数也增加了2.5倍以上[12] - 从估值来看,公司股价目前仅为13倍预期收益,相对较低,适合风险偏好较高的投资者[13][14]

European drug regulators on Friday rejected the Alzheimer's treatment Leqembi from Biogen and Eisai, creating another hurdle for the companies as they scramble to boost uptake of the therapy in the U.S. The European Commission, the EU's executive body, has a final say in Leqembi's approval. But it almost always follows the drug regulator's recommendations. In a statement, Eisai said it is "extremely disappointed" by the regulator's negative recommendation. The company added that it will seek a re-examinatio ...

TOKYO and CAMBRIDGE, Mass., July 26, 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 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monocl ...

NEW YORK, July 25, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Biogen Inc. (NASDAQ: BIIB) on behalf of long-term stockholders following a class action complaint that was filed against Biogen on May 22, 2024 with a Class Period from February 3, 2022 to February 13, 2024. Our investigation concerns whether the board of directors of Biogen have breached their fiduciary duties to the company. Biogen is a glo ...

Biogen Inc. (BIIB) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended June 2024. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The earnings report, which is expected to be released on August 1, 2024, might help the stock move higher if these key numbers are better than expect ...

NEW YORK, July 22, 2024 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Biogen Inc. (NASDAQ: BIIB). Shareholders who purchased shares of BIIB during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/biogen-loss-submission-form/?id=91392&from=3 CLASS PERIOD: February 3, 2022 to Februar ...

SAN DIEGO, July 19, 2024 (GLOBE NEWSWIRE) -- Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Biogen Inc. (NASDAQ: BIIB) securities between February 3, 2022 and February 13, 2024, inclusive (the “Class Period”), have until this upcoming Monday, July 22, 2024 to seek appointment as lead plaintiff in the Biogen class action lawsuit. Captioned Gray v. Biogen Inc., No. 24-cv-01444 (D. Colo.), the Biogen class action lawsuit charges Biogen and certain of Biogen’s top current and former ...

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NEW YORK, July 17, 2024 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Biogen Inc. (NASDAQ: BIIB).Shareholders who purchased shares of BIIB during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/biogen-loss-submission-form/?id=90890&from=4CLASS PERIOD: February 3, 2022 to February 13, 20 ...