Biogen Inc. - BIIB STOCK NEWS

Biogen has entered a collaboration with Alectos Therapeutics to develop AL01811, a preclinical selective GBA2 inhibitor with potential as an oral treatment for Parkinson's Disease (PD). This agreement includes a $15 million upfront payment to Alectos and eligibility for up to $707.5 million in future milestone payments. Currently, no approved disease-modifying therapies exist for PD, affecting 10 million patients globally. Biogen aims to advance therapies for movement disorders that enhance patient quality of life.

Biogen and Bio-Thera Solutions announced promising Phase 3 results for BIIB800, a biosimilar to ACTEMRA. The trial involved 621 patients with moderate to severe rheumatoid arthritis, demonstrating comparable efficacy, safety, and immunogenicity between BIIB800 and the reference product. Key metrics showed ACR20 response rates of 68.97% for BIIB800 versus 64.82% for ACTEMRA at week 12, and 69.89% versus 67.94% at week 24. The data highlights Biogen's commitment to biosimilars, aiming to enhance patient access to essential treatments.

Biogen announced new 12-month data for tofersen, an investigational drug for SOD1-ALS, showing earlier initiation slowed declines in clinical, respiratory, and muscle functions, along with improving quality of life. The analysis, based on the Phase 3 VALOR study, indicated that early initiation may lower the risk of death or permanent ventilation, with robust reductions in neurofilament levels, marking significant neurodegenerative impacts. Despite not meeting primary endpoints in earlier trials, the data suggest potential meaningful benefits for SOD1-ALS patients.

Sage Therapeutics and Biogen announced successful results from the Phase 3 SKYLARK Study of zuranolone, an oral treatment for postpartum depression (PPD). The study achieved its primary endpoint, showing a statistically significant improvement in depressive symptoms at Day 15 with a change from baseline HAMD-17 total score of -15.6 for zuranolone compared to -11.6 for placebo (p=0.0007). Additionally, safety profiles were consistent with previous studies. Zuranolone aims to provide rapid relief for the one in eight women affected by PPD in the U.S.

Eisai and Biogen announced the completion of a rolling submission of a Biologics License Application (BLA) to the FDA for lecanemab (BAN2401), an investigational treatment for mild cognitive impairment due to Alzheimer's disease. The submission is under the accelerated approval pathway, with a request for Priority Review. The Phase 3 Clarity AD trial, involving 1,795 patients, is expected to report results in Fall 2022 and will serve as confirmatory evidence for lecanemab's clinical benefits. The BLA is supported by extensive safety and efficacy data from earlier trials.

Biogen has entered into a license agreement with MedRhythms to develop MR-004, a prescription digital therapeutic aimed at treating gait deficits in multiple sclerosis (MS). Biogen will make a $3 million upfront payment and could pay up to $117.5 million in milestone payments, along with tiered royalties on global sales. This collaboration combines Biogen’s expertise in MS with MedRhythms’ digital technology, offering potential improvements in mobility for MS patients. MR-004 could become the first approved digital therapeutic for gait deficits in MS, supported by ongoing feasibility studies.

Scribe Therapeutics, co-founded by Nobel Laureate Jennifer Doudna, has announced that Biogen (NASDAQ: BIIB) has exercised an option for an additional disease target in their ongoing collaboration. This expansion aims to develop CRISPR-based therapies, further solidifying Scribe's leading role in genetic medicine. The collaboration, which began in 2020 focusing on ALS, highlights Scribe’s custom CRISPR platforms overcoming technical challenges in gene therapy delivery. CEO Benjamin Oakes emphasizes their commitment to advancing transformative genetic treatments.

Sage Therapeutics and Biogen have initiated a rolling submission of a New Drug Application (NDA) for zuranolone to the FDA, targeting major depressive disorder (MDD). The nonclinical module has been submitted, with remaining components expected in H2 2022. Zuranolone is an investigational drug requiring a two-week daily regimen, and is also aimed at treating postpartum depression (PPD), with submissions planned for H1 2023. The drug has previously received Fast Track and Breakthrough Therapy Designations from the FDA, addressing unmet needs in depression treatment.