Biogen Inc. (BIIB)

Biogen (BIIB) shares recorded their fifth consecutive day of increases, accumulating a total return of 14% during this span. The company's market value has increased by approximately $3.3 billion over the past 5 days, bringing its current market capitalization to around $23 billion.

TOKYO and CAMBRIDGE, Mass., Sept. 28, 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®” (brand name in China: “乐意保®”, generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the National Medical Products Administration (NMPA) in China.

Biogen Inc. (NASDAQ:BIIB ) Bernstein 2nd Annual Global Healthcare Conference September 24, 2025 11:20 AM EDT Company Participants Priya Singhal - Executive VP & Head of Development Conference Call Participants William Pickering - Sanford C. Bernstein & Co., LLC.

FDA issues CRL to Biogen's regulatory filing seeking approval for a higher dose of SMA drug, Spinraza. The company plans prompt resubmission.

TOKYO and CAMBRIDGE, Mass., Sept. 24, 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 the Therapeutic Goods Administration (TGA) of Australia has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name, generic name: lecanemab) for mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD) (collectively referred to as early AD) in adults who are either ApoEε4* non-carriers or heterozygous carriers.

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 company's efforts to strengthen its position in a competitive market, the company said on Tuesday.

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.

BIIB secures EU approval for Zurzuvae, the first oral treatment for postpartum depression, boosting its long-term growth prospects.

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 part of an existing partnership with Alcyone Therapeutics, the companies are advancing ThecaFlex DRx™, an implantable subcutaneous port and catheter device being investigated for the intrathecal delivery of antisense oligonucleotides (ASOs). ThecaFlex DRx™ is designed to provide an alternative to repeat lumbar punctures in chronic intrathecal administration of medicines, which could ease both patient experience and accessibility for a broader population of people living with neurologic disorders.

CAMBRIDGE, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) --  Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone) to treat post-partum depression (PPD) in adults following childbirth. ZURZUVAE is a once-daily, oral, 14-day treatment which represents a novel therapeutic approach, offering the first and only treatment indicated for PPD in the E.U.

Biogen Inc. (NASDAQ:BIIB ) Morgan Stanley 23rd Annual Global Healthcare Conference September 8, 2025 10:45 AM EDT Company Participants Christopher Viehbacher - President, CEO & Director Conference Call Participants Terence Flynn - Morgan Stanley, Research Division Presentation Terence Flynn Equity Analyst Great. Good morning, everybody.

WATERTOWN, Mass., Sept. 04, 2025 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced that its partner Biogen has had its investigational new drug (IND) application for BIIB142 accepted by the U.S. Food and Drug Administration (FDA).

Global drugmakers are scrambling to shore up their U.S. manufacturing capacity and domestic inventory as the Trump administration weighs hefty tariffs on pharmaceutical imports into the country.

LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start to help patients and care partners treat this progressive, relentless disease LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start to help patients and care partners treat this progressive, relentless disease

– Durable reductions in seizures and continuing improvements in cognition and behavior through 3 years in patients who continued to receive zorevunersen in the open-label extension studies –