Biogen Inc - BIIB STOCK NEWS

Biogen (BIIB) has received FDA Fast Track designation for BIIB080, its investigational antisense oligonucleotide (ASO) therapy targeting tau for Alzheimer's disease treatment. This designation aims to expedite development and review of drugs addressing serious unmet medical needs.

BIIB080, the first tau-targeting ASO in clinical development for Alzheimer's, demonstrated promising Phase 1b results with dose-dependent reductions in soluble tau protein in cerebrospinal fluid, decreased aggregated tau pathology in the brain, and favorable trends in exploratory clinical outcomes. The high-dose groups showed positive trends across multiple cognitive and functional measures.

The company's Phase 2 CELIA study is now fully enrolled, with data readout expected in 2026.

Organon (NYSE: OGN) has acquired U.S. regulatory and commercial rights for TOFIDENCE™, a biosimilar to ACTEMRA®, from Biogen Inc. (Nasdaq: BIIB). TOFIDENCE, launched in May 2024, is the first approved tocilizumab biosimilar in the U.S. market for intravenous infusion.

The treatment is indicated for multiple conditions including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. The acquisition includes three vial sizes: 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL.

The deal structure includes an upfront payment to Biogen, with Organon assuming tiered royalty payments based on net sales and annual net sales milestone payments owed to Bio-Thera Solutions , who will maintain manufacturing rights for the U.S. market.

Biogen (BIIB) has announced plans for a new global headquarters at Kendall Common in Cambridge, Massachusetts, signing a 15-year lease for approximately 580,000-square-feet of office and research space. The state-of-the-art facility, scheduled to open in 2028 coinciding with Biogen's 50th anniversary, will serve as an innovation hub integrating research, development, technical operations, and commercial teams.

The company will be the sole corporate tenant in the building, which is being developed through a joint venture between MIT Investment Management Company and BioMed Realty. The facility will feature modern laboratories, upgraded workspaces, sustainable design elements, and the Biogen CoLab - a community laboratory space for collaboration with nonprofits, schools, and universities.

Cardurion Pharmaceuticals has appointed Karen Lewis as Chief People Officer, bringing over 25 years of human resources experience to the clinical-stage biotechnology company. Lewis joins from Apellis Pharmaceuticals (APLS), where she served as Chief People Officer and led organizational growth from 200 to over 900 employees globally while supporting the launch of two drug products.

Prior to Apellis, Lewis held leadership positions at Axcella Health, Biogen (BIIB), Amazon, and Bristol-Myers Squibb (BMY). At Biogen, she served as Vice President of Global Talent Acquisition and headed HR for U.S. commercial and Asia Pacific/Latin America operations. Lewis holds a B.S. in biology from Rider University and began her career as a research scientist before transitioning to HR.

Biogen (BIIB) has initiated the Phase 3 TRANSCEND study to evaluate felzartamab for treating late antibody-mediated rejection (AMR) in kidney transplant patients. The study will enroll approximately 120 kidney transplant recipients and compare the drug's efficacy against placebo.

The trial is structured in two parts over 52 weeks: Part A involves nine intravenous infusions over 6 months, with the primary endpoint measuring AMR resolution by biopsy at 6 months. Part B provides all participants with felzartamab for an additional 6 months to evaluate longer-term effects.

AMR affects approximately 23,000 patients in the U.S. and is a leading cause of kidney transplant loss. The study follows promising Phase 2 results, and Biogen plans additional Phase 3 trials for felzartamab in IgA nephropathy and primary membranous nephropathy in 2025. As part of the trial initiation, MorphoSys will receive a $35 million milestone payment from Biogen.

Eisai and Biogen (BIIB) announced that the European Medicines Agency's CHMP has reaffirmed its positive opinion for lecanemab, their anti-Aβ monoclonal antibody treatment for early Alzheimer's disease. This follows the European Commission's January 2025 request to review additional safety information that emerged after the initial November 2024 positive opinion.

The treatment targets an estimated 15.2 million people with mild cognitive impairment due to Alzheimer's and 6.9 million with AD dementia in Europe. If approved by the EC, lecanemab will be available in all 27 EU member states, plus Iceland, Liechtenstein, and Norway.

Lecanemab has already received approval in multiple regions including the US, Japan, China, and South Korea. The FDA recently approved a maintenance dosing schedule of once every four weeks, and a subcutaneous injection formulation is under review to enhance patient convenience.

Biogen and Stoke Therapeutics have entered into a collaboration to develop and commercialize zorevunersen for the treatment of Dravet syndrome, a severe genetic epilepsy. Biogen gains exclusive commercialization rights outside the US, Canada, and Mexico, while Stoke retains rights in these regions. The pivotal Phase 3 EMPEROR study is set to begin in Q2 2025, with results expected in 2H 2027.

Stoke will receive $165M upfront, share development costs, and could earn up to $385M in milestones and royalties. Zorevunersen targets the SCN1A gene, the main cause of Dravet syndrome, and has shown promising results in early trials, reducing seizure frequency and improving cognition and behavior. The drug has received FDA Breakthrough Therapy Designation and will advance to a global Phase 3 study.

This collaboration enhances Biogen's rare disease pipeline and leverages its global commercialization expertise. Dravet syndrome affects up to 38,000 people in the US, UK, EU-4, and Japan, with no current disease-modifying therapies available. The partnership aims to meet significant unmet needs in this patient population.

Biogen and Stoke Therapeutics announced a collaboration for developing and commercializing zorevunersen, a potential first-in-class treatment for Dravet syndrome. Stoke retains rights in US, Canada, and Mexico, while Biogen receives rights for the rest of world.

The deal includes a $165 million upfront payment to Stoke, with potential for $385 million in additional milestones plus tiered royalties. The pivotal Phase 3 EMPEROR study is scheduled to begin in Q2 2025, with results expected in 2H 2027.

Zorevunersen, which targets the SCN1A gene, has received FDA Breakthrough Therapy Designation. Phase 1/2a and open-label extension studies showed substantial reductions in seizure frequency and improvements in cognition and behavior. The treatment addresses an estimated 38,000 patients across the U.S., UK, EU-4, and Japan.

Eisai and Biogen provided an update on the regulatory review of lecanemab for early Alzheimer's disease in the European Union. Following a positive CHMP opinion in November 2024, the European Commission has requested the CHMP to review new safety information that emerged after the initial opinion and evaluate if risk minimization measures are clearly worded.

The companies report that lecanemab's safety profile in clinical practice across the US, Japan, and other markets remains consistent with approved labels, with no new safety signals identified. They believe existing information can address the EC's requests, which will be discussed at the February 2025 CHMP meeting.

Eisai leads the global development and regulatory submissions for lecanemab, with both companies co-commercializing and co-promoting the product. Eisai maintains final decision-making authority.