Biogen Inc Stock Price, News & Analysis

Biogen (NASDAQ:BIIB) announced that ZURZUVAE® (zuranolone) received a positive recommendation from the European Medicines Agency's CHMP for treating postpartum depression (PPD) in adults following childbirth. If approved by the European Commission, ZURZUVAE will become the first specifically-indicated PPD treatment in the European Union.

The recommendation is based on the successful SKYLARK Study, which demonstrated significant reduction in depressive symptoms as early as Day 3, with benefits sustained through Day 45 compared to placebo. ZURZUVAE, a once-daily oral 14-day treatment, was previously approved by the FDA in 2023 and classified as a Class IV controlled substance.

PPD affects an estimated 5-20% of women with pregnancy in Europe, representing a significant unmet medical need. The European Commission's final decision is expected in Q3 2025.

Biogen (NASDAQ:BIIB) announced upcoming presentations at the 2025 Alzheimer's Association International Conference (AAIC) in Toronto from July 27-31. The company will present key data on LEQEMBI® (lecanemab), including 48-month results from the Clarity AD open-label extension and insights into a new subcutaneous formulation for maintenance dosing.

The presentations will also feature tau-related research, including baseline characteristics from the CELIA Phase 2 trial of BIIB080, an investigational antisense oligonucleotide therapy targeting tau. Additionally, Biogen will showcase real-world evidence, treatment comparisons, and host an educational program on tau in Alzheimer's disease through an interactive booth and e-learning resources.

Biogen (NASDAQ:BIIB) has announced a $2 billion investment to expand its manufacturing capabilities in North Carolina's Research Triangle Park (RTP). This significant investment builds upon the company's 30-year manufacturing presence in the region, where it has already invested approximately $10 billion to date.

The expansion will focus on enhancing antisense oligonucleotide capabilities, establishing multi-platform fill finish capabilities, and modernizing manufacturing through advanced automation and AI. As North Carolina's largest biotechnology employer, Biogen currently employs over 1,500 manufacturing and technical staff plus 400 skilled contractors across its Wake County and Durham County campuses.

Biogen (NASDAQ:BIIB) and Stoke Therapeutics presented new data for zorevunersen, their investigational treatment for Dravet syndrome, at the EPNS Congress. The analysis showed improvements in cognition and behavior at Week 68 using the Phase 3 dosing regimen, contrasting with natural history data where patients only received standard care.

The data supports the Phase 3 EMPEROR study design and complements previous findings that demonstrated substantial and durable reductions in major motor seizure frequency through two years of treatment. The treatment regimen involves two loading doses of 70mg followed by maintenance doses of 45mg. Zorevunersen is being developed as a first-in-class potential disease-modifying treatment for Dravet syndrome, which affects up to 38,000 people across major markets.

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.