Biogen Inc. - BIIB STOCK NEWS

Biogen Inc. (NASDAQ: BIIB) has announced the appointment of Chuck Triano as Senior Vice President and Head of Investor Relations, effective April 10, 2023. Reporting to Michael McDonnell, Executive Vice President and CFO, Triano brings over 35 years of financial expertise from various executive roles in the biotechnology and pharmaceutical sectors, including his recent position as CFO at Xalud Therapeutics. McDonnell expressed confidence that Triano's industry insights and relationships will enhance Biogen's communication strategy. The company continues to focus on developing innovative therapies across neurology and related fields.

Biogen has announced the appointment of Caroline Dorsa as Chair of the Board of Directors, effective immediately after the Annual Meeting on June 14, 2023. Dorsa, who has been with Biogen since 2010, will succeed Stelios Papadopoulos, who will not seek reelection. Dorsa emphasized her commitment to building on Papadopoulos's legacy and delivering value to shareholders while advancing therapies for patients. Biogen CEO Christopher A. Viehbacher expressed gratitude for Papadopoulos's leadership during a transformative period for the company. Biogen continues to focus on its mission of innovation in biotechnology.

Sage Therapeutics (SAGE) and Biogen (BIIB) announced that the FDA will not convene an advisory committee to discuss the New Drug Application for zuranolone, a treatment for major depressive disorder (MDD) and postpartum depression (PPD). This investigational drug has been granted priority review, with a Prescription Drug User Fee Act (PDUFA) action date set for August 5, 2023. Zuranolone is part of clinical programs LANDSCAPE and NEST, which include several studies across thousands of participants. The companies remain optimistic about zuranolone's potential, but there are inherent risks and uncertainties in drug approval processes.

Eisai Co., Ltd. and Biogen announced that the FDA accepted Eisai's supplemental Biologics License Application (sBLA) for LEQEMBI (lecanemab-irmb), an Alzheimer's treatment, seeking to convert its accelerated approval to traditional status. The application has received Priority Review, with a target action date of July 6, 2023. The sBLA is based on positive results from the Phase 3 Clarity AD trial, which met primary and secondary endpoints. This indicates the potential for LEQEMBI's continued approval contingent on confirming its clinical benefits in the ongoing study.

Eisai and Biogen announced that the Biologics License Application (BLA) for lecanemab (LEQEMBI) has received Priority Review from China’s National Medical Products Administration (NMPA). This designation aims to expedite the development and launch of significant new medicines. The submission includes data from the Phase II clinical trial and top-line results from the Phase III Clarity AD study, which focused on early Alzheimer’s disease. In the U.S., LEQEMBI received accelerated approval from the FDA on January 6, 2023, reflecting its potential in treating Alzheimer’s. Both companies will co-promote the drug globally.

Biogen (Nasdaq: BIIB) and Sage Therapeutics announced that the FDA has accepted the NDA filing for zuranolone as a treatment for major depressive disorder (MDD) and postpartum depression (PPD). This investigational drug aims to provide a rapid-acting, once-daily oral treatment over 14 days. The FDA granted priority review, with a PDUFA date set for August 5, 2023. Zuranolone's NDA incorporates data from multiple clinical programs including LANDSCAPE and NEST, involving several studies. The companies highlight the significant unmet need for effective and timely treatment of depression, which affects millions and carries substantial economic burdens.

Biogen (Nasdaq: BIIB) and Eisai announced that their application for lecanemab, an anti-amyloid-β antibody, received Priority Review from Japan's Ministry of Health, Labour and Welfare. This designation shortens the review period for medications that show high medical utility for serious diseases. The application was based on Phase III Clarity AD study results, indicating lecanemab's potential to reduce clinical decline in early Alzheimer’s disease (AD). Lecanemab has already gained accelerated approval from the FDA in the U.S. and submitted additional applications to regulatory bodies in Europe and China, indicating a robust global regulatory strategy.

Eisai and Biogen announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab, an investigational anti-amyloid beta antibody for early Alzheimer's disease. This follows the U.S. FDA's accelerated approval of lecanemab on January 6, 2023. Eisai is leading global development and regulatory submissions while co-commercializing with Biogen. A supplemental Biologics License Application for traditional approval has also been submitted to the FDA based on positive Phase III study results.

On January 15, 2023, Eisai Co., Ltd. and Biogen Inc. announced the submission of a marketing authorization application for lecanemab to treat mild cognitive impairment and early Alzheimer's disease in Japan. This follows positive Phase III clinical trial results showing significant reductions in clinical decline among patients. Lecanemab, known as LEQEMBI™ in the U.S., received accelerated FDA approval earlier in January 2023. However, common adverse effects include infusion reactions and amyloid-related imaging abnormalities. Eisai leads global development while both companies co-promote the drug.