Biogen Inc Stock Price, News & Analysis

Biogen has received European Commission approval for QALSODY® (tofersen), a treatment for adults with amyotrophic lateral sclerosis (ALS) linked to a superoxide dismutase 1 gene mutation. This marks the first EU approval targeting a genetic cause of ALS, an ultra-rare form of the disease affecting less than 1,000 people in Europe. The approval is based on a 24-week Phase 3 VALOR study, which showed a 55% reduction in neurofilament light chain levels in treated participants, though primary efficacy results were not statistically significant. Common adverse reactions include pain, fatigue, and increased protein in cerebrospinal fluid. Biogen aims to expedite access across Europe and continues to engage with global regulatory authorities.

Biogen has announced an agreement to acquire Human Immunology Biosciences (HI-Bio) for $1.15 billion upfront, with potential milestone payments up to $650 million. The acquisition includes felzartamab, an anti-CD38 monoclonal antibody with potential applications in various immune-mediated diseases. Felzartamab has received Breakthrough Therapy and Orphan Drug Designations from the FDA for treating primary membranous nephropathy (PMN) and kidney transplant-related antibody-mediated rejection (AMR). Phase 2 studies have shown promise, with plans to advance to Phase 3. The deal aims to combine HI-Bio's expertise with Biogen's global capabilities to accelerate the development of therapies for rare immune diseases.

Ionis Pharmaceuticals and Biogen announced the discontinuation of BIIB105 (ION541), an investigational antisense oligonucleotide for amyotrophic lateral sclerosis (ALS), based on Phase 1/2 ALSpire study results. Despite demonstrating statistically significant reductions in cerebrospinal fluid ATXN2 protein, BIIB105 did not lower plasma neurofilament light chain (NfL) levels, nor did it impact clinical outcomes such as function, breathing, and strength over a 6-month period. Common adverse events included procedural pain, headache, and fall, with higher discontinuation rates in the BIIB105 group. Further analyses of the data are ongoing, and results will be presented at the European Network to Cure ALS (ENCALS) meeting in June 2024.

Eisai has initiated a rolling submission of a Biologics License Application (BLA) to the FDA for LEQEMBI (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing for early Alzheimer's disease. The BLA leverages data from the Clarity AD Study 301 and aims to allow home or medical facility administration, reducing the need for hospital visits compared to IV administration. LEQEMBI has gained approval in the U.S., Japan, and China, with more submissions pending globally. Concerns include amyloid-related imaging abnormalities (ARIA), which can cause serious side effects. Ongoing studies include AHEAD 3-45 and Tau NexGen for preclinical and dominantly inherited Alzheimer's, respectively.

Biogen Inc. (Nasdaq: BIIB) released its 2023 Corporate Responsibility Report, highlighting progress in key areas such as access to medicines, workforce diversity, community impact, and environmental sustainability. The report showcases achievements like adding new medicines to the portfolio, expanding access to treatments, increasing workforce diversity, supporting local communities, and enhancing environmental initiatives.