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17.11.25 - 12:03
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High Dose Regimen of Nusinersen Receives Positive CHMP Opinion for the Treatment of Spinal Muscular Atrophy (GlobeNewswire EN)
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CAMBRIDGE, Mass., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending by consensus the approval of the high dose regimen of nusinersen for the treatment of 5q spinal muscular atrophy (SMA). 5q SMA is the most common form of the disease and represents approximately 95% of all SMA cases.3 The CHMP's Positive Opinion will now be reviewed by the European Commission with a final decision expected in January 2026. If adopted by the European Commission, the high dose regimen will be an additional dosing option to the already approved 12 mg low dose regimen....
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14.11.25 - 22:09
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Biogen Completes Acquisition of Alcyone Therapeutics (GlobeNewswire EN)
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CAMBRIDGE, Mass., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) has completed the acquisition of Alcyone Therapeutics, a clinical-stage biotechnology company known for its innovative CNS therapy delivery solutions, such as the ThecaFlex DRx™ drug delivery system....
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14.11.25 - 11:12
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Eisai and Biogen report Leqembi′s MHRA approval for Alzheimer′s (PBR)
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Leqembi is a humanised anti-soluble aggregated amyloid-beta monoclonal antibody. The development follows the August 2024 approval for treating mild cognitive impairment (MCI) and mild dementia caused by Alzheimer's
The post Eisai and Biogen report Leqembi's MHRA approval for Alzheimer's appeared first on Pharmaceutical Business review....
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14.11.25 - 00:33
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“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer′s Disease Approved in the United Kingdom (GlobeNewswire EN)
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TOKYO and CAMBRIDGE, Mass., Nov. 13, 2025 (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 humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom....
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06.11.25 - 14:42
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Here Are Thursday’s Top Wall Street Analysts Research Calls: Amazon.com, Biogen, Caterpillar, e.l.f. Beauty, Southern Company and More (24/7 Wall St.)
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Pre-Market Futures: The futures are trading modestly higher on Thursday after a big snap-back rally on Wednesday, as all the major indices staged a solid rebound following the Tuesday sell-off. While some of the buying was likely “Buy the Dip” investors doing what has come naturally for the last three years, another possible tailwind was ... Here Are Thursday's Top Wall Street Analysts Research Calls: Amazon.com, Biogen, Caterpillar, e.l.f. Beauty, Southern Company and More
The post Here Are Thursday's Top Wall Street Analysts Research Calls: Amazon.com, Biogen, Caterpillar, e.l.f. Beauty, Southern Company and More appeared first on 24/7 Wall St.....
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03.11.25 - 13:33
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Biogen to Highlight Scientific Progress in Rare Kidney Disease at American Society of Nephrology (ASN) Kidney Week 2025 (GlobeNewswire EN)
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CAMBRIDGE, Mass., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – will present new data from its felzartamab clinical development programs at Kidney Week 2025, the American Society of Nephrology's (ASN) annual meeting, taking place November 5-9 in Houston, Texas. Felzartamab, an investigational anti-CD38 monoclonal antibody, is currently being evaluated in three pivotal Phase 3 studies across multiple kidney indications. The first data readout is anticipated in 2027 from TRANSCEND, a study evaluating felzartamab in adult kidney recipients diagnosed with late antibody-mediated rejection (AMR)....
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