Core Viewpoint - Biogen faces a significant setback as the European Medicines Agency's CHMP issued a negative opinion on the marketing approval for its Alzheimer's therapy, Leqembi, due to safety concerns related to brain swelling [1] Financial Performance - Biogen's stock has declined 18.4% year-to-date, contrasting with a 0.5% increase in the industry [2] - The company experienced a negative earnings surprise of 6.38% in the last reported quarter [2] Sales and Revenue Insights - Sales of Biogen's multiple sclerosis drugs, Tecfidera and Tysabri, are expected to decline due to increased competition and the introduction of generic versions [3] - The Zacks Consensus Estimate for Tecfidera sales is $236 million, while the estimate for Tysabri is $420 million [3] - Sales of Vumerity, another MS drug, are anticipated to rise, with estimates at $154 million [3] - Spinraza's sales growth is expected to be impacted by competition and shipment timing, with estimates at $403 million [5] - Sales of the newly launched rare disease drug Skyclarys are expected to improve from the first quarter [5] - Contract manufacturing and royalty revenues are projected to decline, including Biogen's share from the collaboration with Eisai for Leqembi [6] Product Developments - Leqembi has been launched in the U.S., Japan, and China, with recent approvals in Israel, Hong Kong, and South Korea [1] - The European Commission granted marketing approval to Qalsody for treating ALS in Europe, with encouraging launch uptake in the U.S. [7] Cost Management - Lower cost of sales and operating costs due to cost-saving initiatives are expected to positively impact profits [7] Earnings Expectations - Biogen's Earnings ESP is -1.09%, indicating a lower likelihood of an earnings beat compared to the Zacks Consensus Estimate of $4.00 [9]

Biogen stock has slipped 18% so far this year.Biogen (BIIB -7.15%) built itself into a multiple sclerosis (MS) treatment giant over the years -- but as older blockbusters lost exclusivity, growth stalled. And last year, annual revenue dropped more than 45% to $9.8 billion from its peak back in 2019. Though Biogen launched a new MS drug back in 2019, called Vumerity, it's failed to replicate the growth and revenue levels of its predecessor.To boost growth, Biogen turned to other areas, and has placed a parti ...

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 ...