Biogen Inc Stock Price, News & Analysis

Biogen (Nasdaq: BIIB) has initiated PROMINENT, a Phase 3 clinical study of felzartamab for treating primary membranous nephropathy (PMN). The study will evaluate the drug's efficacy and safety compared to tacrolimus in approximately 180 adults with PMN, with results expected in 2029.

PMN is a rare kidney disease affecting an estimated 36,000 patients in the U.S., with no currently approved treatments. Felzartamab, an investigational anti-CD38 monoclonal antibody, targets CD38+ cells, including plasma cells that produce harmful autoantibodies. Notably, up to 80% of PMN patients have autoantibodies against PLA2R generated by these cells.

The 104-week PROMINENT trial (NCT06962800) will measure complete remission rates of proteinuria at week 104 as its primary endpoint. Previous Phase 2 studies (M-PLACE and NewPLACE) showed promising results, with most patients experiencing reduced aPLA2R titers and improved proteinuria levels. This marks Biogen's third Phase 3 trial of felzartamab launched this year, alongside TRANSCEND for kidney transplant rejection and PREVAIL for IgA nephropathy.

Biogen (NASDAQ:BIIB) announced new clinical data for nusinersen (SPINRAZA®) in treating spinal muscular atrophy (SMA). The DEVOTE Part C study, evaluating a higher dose regimen, showed improvements in motor function across different patient groups. The new dosing comprises two 50 mg loading doses followed by 28 mg maintenance doses every four months.

In DEVOTE Part C, participants previously treated with 12 mg SPINRAZA showed functional improvements after transitioning to the higher dose. Non-ambulatory participants improved by +2.5 on the HFMSE scale. The safety profile remained consistent with the known 12 mg dosing.

The final NURTURE study results demonstrated that 92% of presymptomatic infants achieved independent walking, with all participants surviving and maintaining clinical benefits over eight years. The higher dose regimen is currently under regulatory review globally.

Biogen (NASDAQ:BIIB) has announced positive interim Phase 1 results for salanersen (BIIB115/ION306), a novel treatment for spinal muscular atrophy (SMA). The drug, designed for once-yearly dosing, showed substantial efficacy in children previously treated with gene therapy.

Key findings include 70% reduction in neurofilament light chain at 6 months, sustained through the 1-year dosing interval. In a subgroup of 8 participants, 50% achieved new WHO motor milestones, with mean improvements of 3.3 points in HFMSE and 5.3 points in RULM scores. Both tested doses (40mg and 80mg) were generally well-tolerated, with most adverse events being mild to moderate.

Based on these encouraging results, Biogen is advancing salanersen to registrational stage studies, engaging with global health authorities regarding Phase 3 study design.

Biogen (BIIB) has initiated the BRAVE study, a global Phase 3 clinical trial evaluating omaveloxolone in children aged 2 to <16 years with Friedreich ataxia (FA). The study will enroll approximately 255 participants, randomized 2:1 to receive omaveloxolone or placebo for 52 weeks. The primary outcome measure is the Upright Stability Score (USS), a subscale of the modified FA rating scale. Omaveloxolone is currently marketed as SKYCLARYS® in over 40 countries for FA treatment in patients 16 and older. The study consists of two parts: a 52-week placebo-controlled phase followed by an open-label extension up to week 104. This trial addresses a critical unmet need, as early-onset FA patients often experience more aggressive disease progression, and no approved treatments currently exist for the pediatric population.

UCB and Biogen presented Phase 3 PHOENYCS GO study results for dapirolizumab pegol (DZP) in systemic lupus erythematosus (SLE) at EULAR 2025. The study demonstrated significant improvements in disease activity and fatigue symptoms. DZP showed superior FACIT-Fatigue scores (8.9 vs 5.2) compared to standard of care (SOC). At Week 48, 40.9% of DZP patients achieved low disease activity versus 19.6% with SOC alone, and 19.2% achieved DORIS remission compared to 8.4% with SOC. The safety profile was generally favorable, with 82.6% experiencing treatment-emergent adverse events in the DZP group versus 75% in SOC. A second Phase 3 trial (PHOENYCS FLY) is ongoing to confirm these results. DZP is not yet approved by any regulatory authority for SLE treatment.

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.