Biogen Inc. - BIIB STOCK NEWS

The FDA has granted accelerated approval for QALSODY (tofersen), a treatment for amyotrophic lateral sclerosis (ALS) in adults with a mutation in the SOD1 gene. This approval is based on a reduction of neurofilament, a biomarker for neurodegeneration, in patients. There are approximately 330 individuals in the U.S. living with this rare genetic form of ALS. The ongoing Phase 3 ATLAS study will serve as a confirmatory trial to assess clinical benefits. While the treatment is groundbreaking, there are warnings about serious neurological events associated with its use. Common adverse reactions include pain, fatigue, and muscle pain. QALSODY represents a significant advancement in ALS therapy, being the first approved treatment targeting a genetic cause.

Biogen has announced the appointment of Adam Keeney, Ph.D., as Executive Vice President and Head of Corporate Development, effective April 17, 2023. Dr. Keeney is set to join the Executive Committee and will report to Christopher A. Viehbacher, the company's President and CEO. With over 20 years in biopharmaceutical strategy and business development, Dr. Keeney previously served as CEO of NodThera and held significant roles at Sanofi and Johnson & Johnson. His appointment comes as Biogen aims for sustainable growth and strategic external collaborations.

Eisai and Biogen announced the publication of detailed analyses from the Phase IIb study of lecanemab, focusing on mild cognitive impairment and early Alzheimer's disease. The peer-reviewed journals highlighted biomarker, cognitive, and clinical effects, consistency of results across measures, and the ARIA profile. Study 201 involved 856 patients and revealed a significant reduction in clinical decline. The treatment demonstrated a dose-dependent reduction in brain amyloid accumulation and favorable safety profiles. Additionally, the Phase 3 Clarity AD study results may confirm clinical benefits, as lecanemab remains under Priority Review by the FDA.

Eisai and Biogen announced findings from the Phase 3 Clarity AD trial of lecanemab (LEQEMBI™) for early Alzheimer's disease at the 2023 AD/PD conference. The study, involving 1,795 participants, showed that lecanemab met all primary and secondary endpoints, demonstrating significant efficacy. Notably, ARIA rates were higher with lecanemab compared to placebo, but patients on antiplatelets or anticoagulants had lower ARIA rates. Lecanemab was associated with a 49% reduction in quality-of-life decline at 18 months. Regulatory pathways in the U.S., Japan, and Europe are progressing as lecanemab seeks broader approval.

Biogen announced promising results from the Phase 1b clinical study of its investigational therapy, BIIB080, for early-stage Alzheimer’s disease (AD). The study demonstrated a dose-dependent and sustained reduction in tau protein levels in cerebrospinal fluid (CSF) and aggregated tau pathology in brain regions as measured by PET scans. The trial involved 46 patients and showed approximately a 60% reduction in CSF tau levels by the end of the long-term extension study. Adverse events were largely mild or moderate. BIIB080 targets tau protein production by inhibiting its mRNA, addressing a critical factor in cognitive decline associated with Alzheimer’s.

Biogen Inc. (Nasdaq: BIIB) reported the outcomes of the FDA's Advisory Committee meeting concerning tofersen, a treatment for SOD1-ALS, affecting approximately 330 people in the U.S. The Committee unanimously voted (9-0) that reduced plasma neurofilament light chain (NfL) levels might predict clinical benefits from tofersen, supporting potential accelerated approval.

However, for traditional approval, the Committee voted 3-5-1 against the effectiveness of tofersen based on existing data. The FDA continues to review the New Drug Application, with a decision expected by April 25, 2023.