Biogen and Stoke Therapeutics Present New Data at the 54th Child Neurology Society (CNS) Annual Meeting that Support the Potential of Zorevunersen as a Disease-Modifying Medicine for Dravet Syndrome – An analysis designed to evaluate the potential effects of the Phase 3 zorevunersen dosing regimen showed continuing improvements in cognition and behavior at 2 years; results contrast with minimal change in natural history – – Improvements in overall clinical status at 3 years in the open-label extension studies reported by clinicians and caregivers in 95% of patients treated with zorevunerse...
Downgrading Financials to Underweight We remain bullish since our 4/22/25 Compass, and we will maintain our bullish outlook as long as market dynamics remain healthy and the S&P 500 (SPX) is above 6028-6059. We would need to see a break below 6569 in order to have confidence that a consolidation period has finally begun. For now, we continue to expect support to show up at the 4-month uptrend, which generally coincides with the 20-day MA. Short-term supports to buy include 6640 (the 20-day MA),...
Eisai and Biogen Announce U.S. Availability of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection Maintenance Dose for Treatment of Early Alzheimer’s Disease New LEQEMBI Companion™ program launched to expand helpful resources for patients throughout the treatment journey, including Nurse Educators who can provide patients with injection training, and an injection tracking tool and more LEQEMBI IQLIK, approved by the U.S. FDA in August 2025, is the first and only anti-amyloid treatment to offer an at-home injection after initial treatment of 18 months TOKYO and CAMBRIDGE, Mass.,...
“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in China 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 do...
LEQEMBI® (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Australia 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 d...
Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen CAMBRIDGE, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- 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. The letter did not cite any deficiencies in the c...
Biogen to Acquire Alcyone Therapeutics, Expanding Drug Delivery Solution Portfolio for Key Product and Pipeline Candidates Biogen to drive end-to-end development and commercialization of ThecaFlex DRx™, an investigational implantable device for intrathecal delivery of antisense oligonucleotides (ASOs)ThecaFlex DRx™ has the potential to be a new, convenient way to administer medicines to patients living with neurological disorders. CAMBRIDGE, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Inc. (Nasdaq: BIIB) announced the company has entered into a definitive agreement to acquire Massachusett...
Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe Postpartum depression is a leading cause of maternal mortality in Europe1-2, and is one of the most common medical conditions associated with pregnancy3-5; up to 20% of women experience postpartum depressive symptoms6-11The approval of this new therapeutic approach introduces an oral, 14-day treatment specifically indicated for PPDThe EC approval of ZURZUVAE is based on the SKYLARK study, which demonstrated rapid relief from depressive...
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