Biogen Inc Stock Price, News & Analysis

Biogen (BIIB) presented complete results from Phase 2 IGNAZ study of felzartamab in IgA Nephropathy (IgAN) patients. The study demonstrated substantial proteinuria reductions and stable kidney function, with effects lasting over 18 months post-treatment. The trial (n=54) showed approximately 50% reduction in urinary protein:creatinine ratio through month 24. Felzartamab, an investigational anti-CD38 monoclonal antibody, selectively reduced IgA antibody levels while maintaining IgG and IgM levels. The treatment was generally well-tolerated, and the company is planning Phase 3 development.

Biogen (BIIB) announced upcoming presentations at the Clinical Trials on Alzheimer's Disease (CTAD) annual conference in Madrid, Spain (October 29 - November 1). The company will present new scientific findings from its Alzheimer's portfolio, including data on treatment aspects and preclinical Alzheimer's disease research across different racial groups.

Key presentations will focus on lecanemab treatment in clinical practice, the AHEAD 3-45 study design, and AI-derived prognostic covariates. The company will also host a virtual booth exploring tau's role in Alzheimer's disease, featuring an interactive medical education module on knowtau.com.

Biogen Inc. (Nasdaq: BIIB) announced upcoming data presentations at the American Society of Nephrology's Kidney Week 2024 in San Diego, California. The presentations will focus on felzartamab, an investigational anti-CD38 monoclonal antibody being developed for rare immune-mediated diseases.

Key highlights include:

• A late-breaking oral presentation featuring final results from the Phase 2 IGNAZ study of felzartamab for IgA nephropathy (IgAN)
• An oral presentation examining felzartamab's impact on key disease-relevant biomarkers
• A poster presentation on felzartamab's mechanisms of action

Biogen is planning to advance felzartamab into Phase 3 development as a potential first-in-class therapeutic for various rare immune-mediated indications.

Biogen Inc. (Nasdaq: BIIB) announced that felzartamab, an investigational anti-CD38 monoclonal antibody, has received Breakthrough Therapy Designation (BTD) from the U.S. FDA for treating late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients. The designation is based on clinical proof of concept data and aims to expedite development and review of drugs for serious conditions with potential for substantial improvement over existing therapies.

Felzartamab is being developed as a potential first-in-class therapeutic for various rare immune-mediated indications. It has previously received BTD and Orphan Drug Designation for primary membranous nephropathy (PMN) and ODD for AMR in kidney transplant recipients. Biogen plans to initiate Phase 3 trials for felzartamab in AMR, IgA nephropathy, and PMN in 2025.

Talkiatry, a leading provider of in-network psychiatric care, has announced a new pathway for postpartum depression (PPD) support. This initiative aims to improve access to care for women experiencing postpartum mental health challenges through virtual appointments with board-certified psychiatrists. The company has launched new educational resources to help women identify PPD symptoms and schedule virtual consultations if needed.

Approximately one in eight new mothers in the United States report experiencing PPD symptoms. Despite its prevalence, access to timely care remains challenging due to a shortage of psychiatrists and long wait times. Talkiatry's telehealth alternative, developed in partnership with Biogen Inc. (Nasdaq: BIIB), aims to address these gaps in maternal mental healthcare.

The new PPD page on Talkiatry's website offers educational information, an online assessment tool, and a scheduling system for appointments with psychiatrists. Talkiatry provides virtual psychiatry and therapy covered by over 60 health insurance plans across 43 states, with new patients seen within days of making an appointment.

Biogen Inc. (Nasdaq: BIIB) has announced positive results from Parts B and C of the Phase 2/3 DEVOTE study, evaluating a higher dose regimen of nusinersen in spinal muscular atrophy (SMA). The study showed benefits in both previously treated and treatment-naïve individuals with infantile-onset or later-onset SMA.

Key findings include:

• The higher dose regimen (50/28 mg) led to significant improvements in motor function compared to a matched sham group
• More rapid reduction in neurofilament light chain (NfL), indicating faster slowing of neurodegeneration
• 67.8% reduction in the risk of death or permanent ventilation compared to sham
• Improvements in motor function for participants transitioning from the approved 12 mg regimen to the higher dose
• Safety profile similar to the approved 12 mg regimen

Biogen plans to submit regulatory applications globally for approval of the nusinersen higher dose regimen.

UCB and Biogen (NASDAQ: BIIB) announced positive topline results from the Phase 3 PHOENYCS GO study of dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, for moderate-to-severe systemic lupus erythematosus (SLE). The study met its primary endpoint, demonstrating greater improvement in disease activity compared to placebo after 48 weeks. Key secondary endpoints measuring disease activity and flares also showed clinical improvements.

Based on these results, UCB and Biogen are initiating a second Phase 3 trial, PHOENYCS FLY, in 2024. The companies aim to address the substantial unmet medical need for SLE patients, particularly women who are disproportionately affected. The safety profile of dapirolizumab pegol was generally consistent with previous studies and expectations for SLE patients receiving an immunomodulator.

Biogen Inc. (Nasdaq: BIIB) has announced the appointment of two new independent directors to its Board. Dr. Lloyd Minor, Dean of Stanford University School of Medicine, will join on October 1, 2024, and Prof Sir Menelas Pangalos, former Executive VP of Biopharmaceuticals R&D at AstraZeneca, will join on January 1, 2025.

These appointments bring significant scientific expertise and experience in medicine research and development to Biogen's Board. Dr. Minor has played a key role in Stanford Medicine's strategy and leadership, while Prof Sir Pangalos has a strong track record in biopharmaceutical R&D transformation.

The Board expects these new directors to contribute fresh perspectives and deep scientific knowledge to bolster Biogen's portfolio and drive long-term, sustainable growth.

Biogen Inc. (Nasdaq: BIIB) has announced positive topline results from the Phase 2/3 DEVOTE study evaluating a higher dose regimen of nusinersen for treating spinal muscular atrophy (SMA). The study met its primary endpoint, showing statistically significant improvement in motor function compared to a matched sham control group. The new regimen comprises a more rapid loading schedule and a higher maintenance dose than the approved SPINRAZA regimen.

Key findings include:

• Significant improvement in CHOP-INTEND scores at six months
• Faster reduction in neurofilament levels, indicating slower neurodegeneration
• Generally well-tolerated safety profile
• Positive trends across secondary endpoints and key biomarkers

Biogen plans to submit for regulatory approval of this investigational higher dose regimen, aiming to address the ongoing unmet needs in SMA treatment.