Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result that showed improvements in cutaneous lupus erythematosus (CLE) skin disease activity Litifilimab has the potential to be a first-in-class therapy targeting blood dendritic cell antigen 2 (BDCA2) in CLE, a chronic autoimmune skin disease that has a substantial impact on the daily life of patients, and may result in permanent scarring and disfigurement FDA Breakthrough Therapy Designation is granted to expedite the development and review of drugs for serious diseases CAMBRIDGE, Mass., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for litifilimab (BIIB059) for the treatment of cutaneous lupus erythematosus (CLE).

If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing for this progressive, relentless disease FDA action date set for May 24, 2026 TOKYO and CAMBRIDGE, Mass., Jan. 25, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd.

Biogen CEO Chris Viehbacher joins 'Squawk Box' to discuss the company's 2026 outlook, drug pipeline, the focus on rare diseases, state of the biotech sector, and more.

Biogen Inc. (BIIB) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript

CAMBRIDGE, Mass., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the European Commission (EC) has granted marketing authorization for a high dose regimen of SPINRAZA® (nusinersen) which is comprised of 50 mg/5 mL and 28 mg/5 mL doses 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.2 The SPINRAZA European Union marketing authorization has been updated to include the high dose regimen. The new high dose regimen comprises a more rapid loading phase, two 50 mg loading doses administered 14 days apart and 28 mg maintenance dose injections every four months thereafter. Individuals transitioning from the 12 mg dose will receive one 50 mg dose in place of their next 12 mg dose, followed by 28 mg maintenance doses every four months thereafter. SPINRAZA is for intrathecal use by lumbar puncture by health care professionals experienced in performing lumbar punctures.

Cerity Partners LLC raised its position in shares of Biogen Inc. (NASDAQ: BIIB) by 76.7% in the undefined quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission. The firm owned 82,248 shares of the biotechnology company's stock after buying an additional 35,696 shares during the period.

If approved, lecanemab may become the first and only anti-amyloid treatment in China to offer an at-home injection from the initiation of treatment for this progressive, relentless disease If approved, lecanemab may become the first and only anti-amyloid treatment in China to offer an at-home injection from the initiation of treatment for this progressive, relentless disease

Biogen Inc. shares, despite retail investor pessimism, rose 15.1% in 2025. Besides the successful launch of Leqembi, I highlight Skyclarys, an Nrf2 activator for the treatment of Friedreich's ataxia, as a driver of Biogen's EBIT growth. Its sales totaled $132.9 million in Q3, up 29.9% year-over-year.

CAMBRIDGE, Mass., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – today announced that The Journal of the American Medical Association (JAMA) Neurology has published final results from the completed Phase 3 VALOR study and its open-label extension (OLE) study evaluating QALSODY® (tofersen) for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS) with over 3.5 years of follow-up. These results show that early initiation of QALSODY was associated with numerically slower decline in measures of clinical function, breathing and strength, as well as reduction in the risk of death or permanent ventilation. Sustained reductions in neurofilament, a marker of neurodegeneration, further validate the clinical results and demonstrate QALSODY's impact on the underlying biology of SOD1-ALS.

TOKYO and CAMBRIDGE, Mass., Dec. 08, 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 anti-Aβ protofibril* antibody “LEQEMBI®” (brand name in China: “乐意保®”, generic name: lecanemab), has been included in the “Commercial Insurance Innovative Drug List” (Chinese: 商业健康保险创新药品目录), recently introduced by the National Healthcare Security Administration (NHSA) of China. The inclusion of LEQEMBI in this list marks a meaningful step toward expanding access to early Alzheimer's Disease (AD) treatment in China.