Biogen Inc. - BIIB STOCK NEWS

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.

Biogen has revealed new data from its multiple sclerosis (MS) therapies at the American Academy of Neurology (AAN) 2022 Annual Meeting. Key findings include the efficacy and safety of TYSABRI (natalizumab) administered every six weeks, showing an 87% reduction in progressive multifocal leukoencephalopathy (PML) risk compared to the four-week regimen. Additionally, VUMERITY (diroximel fumarate) demonstrated high persistence at 82.3% and adherence rates of 90.8%. These results underscore Biogen's commitment to advancing MS treatment through clinical research and innovative digital health approaches.

Biogen has submitted the final study protocol for the confirmatory Phase 4 ENVISION trial of ADUHELM, aiming for an accelerated timeline of four years. Patient screening will commence in May 2022, targeting 1,500 participants with early Alzheimer's disease, especially from diverse backgrounds. The trial is a requirement following FDA's earlier accelerated approval of ADUHELM. Biogen plans to recruit at least 18% of participants from underrepresented communities and will implement strategies to address enrollment barriers.

Biogen and Ionis announced the discontinuation of the clinical program for BIIB078, an investigational antisense oligonucleotide for C9orf72-associated amyotrophic lateral sclerosis (ALS), after it failed to demonstrate clinical benefit in a Phase 1 trial. The study showed no consistent efficacy between the drug and placebo across dose cohorts, with higher doses trending toward a greater decline in secondary endpoints. Despite this setback, both companies remain committed to advancing ALS research and exploring other investigational therapies targeting the disease.

Biogen and Ionis Pharmaceuticals announced the Phase 1 study results of BIIB078, an investigational drug for C9orf72-associated ALS. The study, involving 106 participants, found that BIIB078 did not demonstrate any clinical benefit and failed to meet secondary efficacy endpoints. As a result, the clinical program for BIIB078 will be discontinued. Although well-tolerated, the study highlighted that the disease mechanism is more complex than initially hypothesized. Both companies remain committed to advancing ALS research and addressing this neurodegenerative disease.

Eisai and Biogen presented key findings on lecanemab, an investigational antibody for early Alzheimer's disease, at the 2022 AD/PD conference. The studies highlighted lecanemab's clinical efficacy, dosing regimens, and amyloid-related imaging abnormalities (ARIA) rates. Lecanemab demonstrated a rapid and thorough amyloid clearance, with 65% of participants amyloid negative at 12 months. The ongoing Phase 3 Clarity AD trial has 1,795 participants, expecting results in Fall 2022. The FDA granted Breakthrough Therapy designation for lecanemab in 2021.

Biogen announced that the Journal of Prevention of Alzheimer’s Disease published data from pivotal Phase 3 EMERGE and ENGAGE trials of ADUHELM (aducanumab-avwa) for early Alzheimer’s disease. The publication includes detailed results on primary, secondary, and tertiary endpoints, along with safety data. ADUHELM received accelerated FDA approval in June 2021 as the first treatment targeting Alzheimer's pathology, contingent on verification of clinical benefit. Biogen now holds sole authority over ADUHELM's development after partnering with Eisai.

Biogen (Nasdaq: BIIB) has announced positive findings from the long-term extension phase of its Phase 3 trials for ADUHELM (aducanumab-avwa), revealing significant reductions in Alzheimer's disease pathologies, specifically amyloid beta plaques and plasma p-tau181, after nearly 2.5 years of treatment. Patients showing reduced plasma p-tau181 experienced less clinical decline by 78 weeks. The incidence of ARIA-E side effects was noted at 35.2%, with higher rates in APOE ε4 carriers. These results were presented at the international AD/PD 2022 conference.