Biogen Inc. - BIIB STOCK NEWS

Eisai and Biogen received a positive opinion from the European Medicines Agency's CHMP for lecanemab in treating early Alzheimer's disease. The treatment is recommended for adult patients with mild cognitive impairment and mild dementia due to Alzheimer's, specifically for ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology. The European Commission's final decision is expected within 67 days. In clinical trials, lecanemab showed a 31% reduction in clinical decline compared to placebo at 18 months, and demonstrated a 33% less decline in daily living activities. The drug is already approved in several countries including the U.S., Japan, and China.

Eisai has completed a rolling Biologics License Application (BLA) submission to the FDA for LEQEMBI® subcutaneous autoinjector for weekly maintenance dosing in early Alzheimer's disease treatment. The submission, under Fast Track designation, is based on data from the Clarity AD open-label extension study. If approved, patients could self-administer LEQEMBI at home in approximately 15 seconds after completing the initial biweekly intravenous phase. The autoinjector option aims to maintain effective drug concentrations while offering greater convenience compared to IV administration.

Eisai and Biogen presented new findings for lecanemab-irmb (LEQEMBI), their Alzheimer's disease treatment, at the CTAD Conference. Three-year continuous treatment data showed significant benefits: 59% of patients with no/low tau accumulation showed improvement or no decline, while 46% of patients with low amyloid levels improved or had no decline on cognitive scales. A new testing method revealed strong correlation between protofibrils and neurodegenerative biomarkers. Long-term safety profile remained consistent with no new concerns, with most ARIA events occurring in the first six months of treatment.

Biogen (BIIB) and Neomorph have announced a research collaboration to develop molecular glue degraders for Alzheimer's, rare neurological, and immunological diseases. The partnership combines Neomorph's molecular glue discovery platform with Biogen's expertise in disease research and drug development. Under the agreement, Neomorph will receive an upfront payment and is eligible for milestone payments totaling up to $1.45 billion, plus potential royalties ranging from mid-single digit to low double-digit percentages. The collaboration aims to identify and validate small molecule therapeutic molecular glue degraders for high-priority targets, with Biogen leading the clinical development and commercialization efforts.

Biogen has appointed Daniel Quirk, MD as Chief Medical Officer and Head of Medical Affairs, effective October 28, 2024. Dr. Quirk will report to Priya Singhal, Head of Development. Previously, he served as Senior Vice President of Worldwide Medical Affairs for Immunology and Neuroscience at Bristol-Myers Squibb, and held leadership positions at Pfizer. Dr. Quirk's background includes medical practice as Associate Chief of Gastroenterology at Thomas Jefferson University Health Systems, with degrees from Brown University (MD), Harvard School of Public Health (MPH), and Wharton School (MBA).

Biogen (NASDAQ: BIIB) announced that Executive Vice President and CFO Michael McDonnell will retire on February 28, 2025. Robin Kramer, current Chief Accounting Officer, will succeed him as CFO. McDonnell, who served since August 2020, led cost structure realignment and strategic acquisitions. Kramer, who joined Biogen in 2018, has overseen key finance functions including Treasury and global procurement. She brings extensive experience from roles at Hertz Global Holdings, Fisher Scientific, and The Gillette Company, and was an audit partner at major accounting firms. The transition will occur over the coming months to ensure continuity in Biogen's financial leadership.

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.