Biogen Inc. - BIIB STOCK NEWS

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.

Biogen (Nasdaq: BIIB) announced a favorable ruling from the Court of Justice of the European Union regarding the regulatory marketing protection for its drug TECFIDERA (dimethyl fumarate). The court's decision upheld Biogen's position that TECFIDERA is entitled to regulatory protection in the EU until at least February 4, 2024, and reinforced its patent rights, which expire in 2028. This outcome aligns with Biogen's previously issued 2023 financial guidance. The company remains proactive in defending its intellectual property and advancing its extensive pipeline of therapies across various medical areas.

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.