Biogen Inc Stock Price, News & Analysis

Biogen (NASDAQ: BIIB) and City Therapeutics have announced a strategic collaboration to develop novel RNA interference (RNAi) therapies. The partnership combines City Therapeutics' next-generation RNAi engineering technologies with Biogen's drug development expertise. The initial focus will be on a single target for central nervous system diseases, with Biogen managing IND-enabling studies, clinical development, and commercialization.

Under the agreement, City Therapeutics will receive $46 million in total payments, including a $16 million upfront payment and a $30 million investment via convertible note. The company could earn up to $1 billion in potential milestone payments plus tiered royalties ranging from high single-digit to low double-digit percentages. Biogen has an option to select one additional target for the collaboration.

Leqembi® (lecanemab) has received Marketing Authorization from the European Commission, becoming the first therapy targeting an underlying cause of Alzheimer's disease (AD) to be authorized in the EU. The treatment is specifically indicated for adult patients with mild cognitive impairment and mild dementia due to early AD who are apolipoprotein E ε4 non-carriers or heterozygotes with confirmed amyloid pathology.

The authorization applies to all 27 EU Member States plus Iceland, Liechtenstein, and Norway. Leqembi is unique as the only approved Aβ monoclonal antibody that preferentially binds and clears toxic protofibrils, while also targeting and reducing Aβ plaques. This development addresses a significant unmet need in Europe, where an estimated 15.2 million people have MCI due to AD and 6.9 million have AD dementia.

Eisai and Biogen (BIIB) will co-promote the medicine in the EU, with Eisai serving as the Marketing Authorization Holder. In Nordic countries, Eisai and BioArctic will handle co-promotion.

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.