Biogen Inc Stock Price, News & Analysis

Sage Therapeutics and Biogen announced disappointing topline results from their Phase 2 KINETIC 2 study of SAGE-324 (BIIB124) for treating essential tremor (ET). The study failed to demonstrate a statistically significant dose-response relationship or any significant differences between SAGE-324 doses and placebo in reducing tremor severity. Key findings include:

- No statistically significant improvements in the primary endpoint (TETRAS Performance Subscale Item 4 total score) or secondary endpoint (TETRAS Activities of Daily Living Composite Score)
- 147 participants were randomized to placebo, 15 mg, 30 mg, or 60 mg doses
- Common side effects included somnolence, dizziness, and fatigue
- Dose-related increases in CNS depressant side effects were observed

As a result, Sage and Biogen will discontinue further clinical development of SAGE-324 for essential tremor.

Biogen (Nasdaq: BIIB) has finalized its acquisition of Human Immunology Biosciences (HI-Bio), a clinical-stage biotech firm focused on targeted therapies for severe immune-mediated diseases (IMDs). This acquisition brings the promising late-stage therapeutic candidate felzartamab into Biogen’s pipeline. Felzartamab has shown positive interim results in Phase 2 trials for IgA nephropathy (IgAN) and antibody-mediated rejection (AMR), and proof-of-concept in primary membranous nephropathy (PMN). Biogen aims to advance felzartamab to Phase 3 trials for these indications, bolstering its immunology portfolio.

Key figures from both companies expressed enthusiasm about the merger, highlighting shared values and a commitment to innovative treatments for patients with unmet needs.

On June 27, 2024, Eisai and Biogen announced the launch of the Alzheimer's drug LEQEMBI® (lecanemab) in China, marking the third country to launch the drug after the U.S. and Japan. LEQEMBI received approval in January 2024 for treating mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD). The drug, which binds to and reduces soluble and insoluble amyloid-beta aggregates, is the first approved treatment shown to slow disease progression and cognitive decline.

With an estimated 17 million early AD patients in China, Eisai is focusing on early diagnosis and treatment through medical representatives and collaborations with health insurance companies, private health checkups, and nursing homes. The company is also working on building an early AD diagnosis pathway using online and offline services, including the "Yin Fa Tong" online health platform. Initially, LEQEMBI will be available in the private market, supported by a new healthcare insurance plan covering part of the drug cost.

Biogen announced that the European Commission has approved TOFIDENCE™, a biosimilar monoclonal antibody referencing ROACTEMRA®. This approval covers its use for treating moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

TOFIDENCE's approval is based on extensive analytical, non-clinical, and clinical data, demonstrating its comparability to the reference product. Clinical trials confirmed its similar pharmacokinetic, safety, and efficacy profiles.

This addition enhances Biogen's immunology biosimilars portfolio, aiming to provide more treatment options and potential cost savings in European healthcare systems.

The FDA has accepted Eisai's Supplemental Biologics License Application (sBLA) for LEQEMBI® (lecanemab-irmb), a monthly intravenous (IV) maintenance dose to treat early Alzheimer's Disease (AD). A Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025. LEQEMBI demonstrated continued efficacy in removing toxic protofibrils through Phase 2 and Phase 3 studies. Approval could simplify long-term treatment. Eisai also initiated a rolling submission to the FDA for a subcutaneous autoinjector version. LEQEMBI is approved in the U.S., Japan, China, and South Korea, with additional applications in several other countries.

Biogen (Nasdaq: BIIB) and Delta Flight Products (DFP) announced a collaboration to enhance air travel for passengers with reduced mobility, focusing on individuals who rely on wheelchairs. Approximately 5.5 million Americans depend on wheelchairs for mobility. The partnership aims to gather insights from community events to develop innovative travel solutions, such as a new airplane seat prototype that allows passengers to use their wheelchairs during flights. The initiative will be showcased at the Cure SMA Annual Conference in Austin, Texas, from June 6-9, 2024. Feedback from these events will help inform future advancements, aiming for more equitable and accessible air travel.

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.