Biogen Inc Stock Price, News & Analysis

The FDA has granted accelerated approval for LEQEMBI™ (lecanemab-irmb), a monoclonal antibody aimed at treating Alzheimer's disease. This decision was based on Phase 2 data indicating a reduction in amyloid-beta plaques in early-stage patients. LEQEMBI is intended for individuals with mild cognitive impairment or mild dementia, with treatment requiring baseline MRI scans and ongoing monitoring for potential side effects like amyloid-related imaging abnormalities (ARIA). Eisai plans a Supplemental Biologics License Application for traditional approval soon.

Biogen has announced the promotion of Priya Singhal, M.D., M.P.H. to Executive Vice President, Head of Development, following a restructuring that separates Research and Development into distinct functions. Dr. Singhal, who was previously Interim Head of R&D, will oversee development programs while a search for a new Executive Vice President, Head of Research, is underway. This strategic move, according to CEO Christopher Viehbacher, aims to enhance productivity and better manage risks and resources, ultimately aiming to deliver innovative therapies for challenging diseases.

Biogen has partnered with Alcyone Therapeutics to develop the ThecaFlex DRx™ System, an implantable device aimed at delivering antisense oligonucleotide therapies for neurological disorders like SMA and ALS. This collaboration includes a $10 million upfront payment and potential milestone payments up to $41 million, contingent on development achievements. The ThecaFlex DRx™ has received CE Mark in Europe and Breakthrough Device Designation from the FDA, paving the way for future clinical studies. Biogen seeks to enhance patient treatment experiences with this innovative delivery method.

Eisai Co., Ltd. and Biogen Inc. have initiated the submission of a Biologics License Application (BLA) for lecanemab to China's National Medical Products Administration (NMPA). This Category 1 drug aims to treat Alzheimer's disease and has shown positive results in clinical trials, including the Phase III Clarity AD study, which met its primary and key secondary endpoints. The submission package includes data from Phase II and III trials with significant efficacy outcomes. Eisai plans to seek additional approvals in Japan and Europe by March 31, 2023.

Biogen (Nasdaq: BIIB) has announced a commercialization agreement with Genentech regarding glofitamab, a bispecific antibody targeting B-cell non-Hodgkin’s lymphoma. Biogen will incur no payment obligations and is set to earn tiered royalties on net sales in the U.S. Glofitamab, currently in development, is designed to activate T-cells to eliminate cancer B cells. Pending regulatory approval, it may become a first-in-class treatment. This collaboration reinforces Biogen's long-standing partnership with Genentech in developing anti-CD20 antibodies.

Biogen Inc. (Nasdaq: BIIB) announced the FDA's acceptance for review of its abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar referencing ACTEMRA® (tocilizumab). This biosimilar is aimed at treating moderate to severe rheumatoid arthritis and is supported by Phase 3 clinical trial data showing equivalent efficacy and safety compared to the reference product. The data was previously presented at the European Congress of Rheumatology and ACR. Biogen holds exclusive rights to BIIB800, excluding China, under an agreement with Bio-Thera Solutions.

Sage Therapeutics and Biogen have completed the NDA submission for zuranolone, a rapid-acting oral treatment for major depressive disorder (MDD) and postpartum depression (PPD). This 14-day treatment aims to provide quicker symptom relief compared to existing therapies. The NDA integrates data from the LANDSCAPE and NEST programs, which included multiple studies in adults with MDD and women with PPD. Zuranolone has received Fast Track and Breakthrough Therapy designations by the FDA, indicating its potential significance in treating depression.

Biogen (Nasdaq: BIIB) announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for tofersen, aimed at treating SOD1-ALS, a rare form of amyotrophic lateral sclerosis affecting approximately 2% of ALS patients. Tofersen is positioned to be the first therapy targeting a genetic cause of ALS. The MAA includes comprehensive results from various clinical trials, including the Phase 3 VALOR study. Tofersen is also under FDA review, with a Prescription Drug User Fee Act action date set for April 25, 2023, as Biogen continues its commitment to ALS research.

Eisai and Biogen announced the publication of results from the Phase 3 Clarity AD study of lecanemab, an investigational antibody aimed at treating early Alzheimer's disease with confirmed amyloid pathology. The results, published in the New England Journal of Medicine, reinforce Eisai's commitment to transparency in disclosing data on lecanemab. Eisai leads global development and regulatory submissions, targeting expedited delivery of lecanemab to patients. The FDA's decision on traditional approval is anticipated around January 6, 2023.