Biogen Inc Stock Price, News & Analysis

Biogen Inc. (Nasdaq: BIIB) has appointed Michael McDonnell as Executive Vice President and Chief Financial Officer, effective August 15, 2020. Previously CFO at IQVIA, McDonnell will oversee global finance, IT, and investor relations at Biogen. He succeeds Jeffrey Capello, who will assist in the transition before departing on September 15, 2020. CEO Michel Vounatsos expressed confidence in McDonnell’s strategic financial expertise, highlighting the importance of his role amid Biogen's potential breakthroughs in neuroscience.

Biogen (Nasdaq: BIIB) announced plans for a global Phase 4 clinical study, RESPOND, to assess the efficacy and safety of SPINRAZA in infants and children with spinal muscular atrophy (SMA) who have unmet clinical needs after Zolgensma treatment. The study aims to include 60 participants, with a focus on those exhibiting suboptimal motor function. Previous studies indicated that 4 out of 10 patients treated with Zolgensma proceeded to SPINRAZA. Biogen's ongoing commitment involves generating data to enhance treatment decisions for SMA patients.

On July 13, 2020, the Alzheimer's Clinical Trials Consortium (ACTC), Eisai, and Biogen announced the initiation of a new Phase III study, AHEAD 3-45, for BAN2401, an anti-amyloid beta antibody. This study aims to address preclinical Alzheimer's disease in over 1400 participants across multiple countries, focusing on early intervention to prevent cognitive decline. The study will utilize a rigorous endpoint evaluation, including amyloid and tau PET imaging and cognitive assessments. Results from this trial could provide valuable insights on the timing of anti-amyloid therapy interventions.

Biogen announced positive results from a Phase 1/2 study of tofersen (BIIB067), targeting SOD1 amyotrophic lateral sclerosis (ALS). The study, published in The New England Journal of Medicine, showed proof-of-concept, demonstrating a 36% reduction in SOD1 protein concentration in treated patients. Serious adverse events occurred, including two deaths in the tofersen group. Biogen emphasizes its commitment to ALS research despite past challenges. A Phase 3 study, VALOR, is currently underway to further assess tofersen's efficacy and safety.

Biogen and Eisai have submitted a Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease, to the FDA. This submission includes data from the Phase 3 EMERGE and ENGAGE studies, with a request for Priority Review. If approved, aducanumab would be the first therapy to significantly alter the progression of Alzheimer’s disease by removing amyloid beta. EMERGE showed a 22% reduction in clinical decline compared to placebo at 78 weeks. The FDA has 60 days to accept the application for review.

Biogen (Nasdaq: BIIB) announced significant results from the extended NURTURE study on SPINRAZA (nusinersen) for pre-symptomatic patients with spinal muscular atrophy (SMA). After up to 4.8 years of treatment, 100% of the 25 infants remained alive without requiring permanent ventilation. Additionally, 96% can now walk with assistance, showcasing progressive motor function gains. The study, now extended to assess efficacy and safety until the age of 8, emphasizes early treatment’s transformative impact on SMA outcomes. SPINRAZA remains well-tolerated with no new safety concerns identified.

Biogen announced promising results from the 16-week cutaneous lupus erythematosus (CLE) phase of the Phase 2 LILAC study for BIIB059. Participants receiving BIIB059 experienced significant reductions in disease activity, with improvements in the CLASI-A score of 38.8% to 47.9% compared to placebo. The study indicated safety and tolerability, with most adverse events being mild to moderate. Biogen aims to develop effective treatments for patients with lupus, addressing a critical need for effective therapeutic options in this chronic autoimmune disease.

Biogen announced new data on SPINRAZA, demonstrating its long-term efficacy and safety in treating spinal muscular atrophy (SMA). Presenting at the 72nd AAN annual meeting, findings from the SHINE study show motor function improvements or stabilization in patients treated for up to six and a half years. Key highlights include significant benefits observed in infants and young adults, with a consistent safety profile. Over 10,000 individuals have been treated with SPINRAZA, enhancing its position as the primary SMA treatment.