Biogen Inc Stock Price, News & Analysis

On November 18, 2020, Samsung Bioepis and Biogen announced that the FDA accepted the Biologics License Application for SB11, a biosimilar to Lucentis® (ranibizumab), aimed at treating retinal vascular disorders, a leading cause of blindness in the U.S.

This milestone could significantly improve access to affordable therapies, with projected savings exceeding $100 billion over five years from biosimilars in the U.S. If approved, SB11 is expected to help millions of patients.

The FDA Advisory Committee evaluated aducanumab for Alzheimer's treatment, resulting in a 1 yes, 8 no vote on its effectiveness based on Study 302. Study 103 received 0 yes votes supporting its efficacy. The committee expressed skepticism about aducanumab's primary evidence as effectiveness. Biogen CEO Michel Vounatsos acknowledged the unmet need for Alzheimer's treatment and emphasized ongoing FDA collaboration. The FDA aims to make a decision by March 7, 2021. Aducanumab, if approved, could be the first meaningful treatment altering Alzheimer's progression.

Biogen announced positive results from the Phase 2 LILAC study of BIIB059, a monoclonal antibody targeting BDCA2, for systemic lupus erythematosus (SLE). The study demonstrated a statistically significant reduction in total active joint count by 3.4 at 24 weeks (p=0.037) compared to placebo. The SLE Responder Index-4 (SRI-4) showed a higher response rate of 56.77% for BIIB059 versus 30.42% for placebo (p=0.003). Mild to moderate adverse events occurred in the majority, with serious events at 5.3% for BIIB059. Biogen aims to advance BIIB059 into Phase 3 trials, reinforcing its commitment to lupus treatment.

Biogen (Nasdaq: BIIB) and Eisai announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for aducanumab, an experimental Alzheimer’s disease treatment. If approved, aducanumab would be the first therapy to significantly alter the course of Alzheimer’s. Clinical trials demonstrated its ability to remove amyloid beta and improve clinical outcomes, indicating potential in slowing cognitive decline. Aducanumab is also under U.S. FDA review with a decision expected by March 7, 2021.

Abarca, a pharmacy benefit manager, announced a value-based agreement with Biogen (NASDAQ: BIIB) for drugs Avonex® and Tecfidera®, aimed at improving outcomes for Medicaid patients in Puerto Rico. This collaboration, initiated in 2017, represents the first publicly disclosed value-based agreement for Medicaid populations. Abarca's president emphasized that such contracts are vital for future pharmacy benefits, and Biogen's president expressed commitment to connecting real-world outcomes with therapy costs.

Samsung Bioepis and Biogen announced that the European Medicines Agency (EMA) has accepted their Marketing Authorisation Application for SB11, a proposed biosimilar of Lucentis (ranibizumab), targeting retinal vascular disorders. This application acceptance highlights their collaboration toward providing affordable treatment options. If approved, SB11 will enhance Biogen's biosimilar portfolio, supporting financial sustainability in healthcare. The collaboration aims to address pressing health needs and ensure patient access to essential therapies.

Biogen (Nasdaq: BIIB) has announced the launch of the Healthy Climate, Healthy Lives™ initiative, a $250 million, 20-year plan to eliminate fossil fuels from its operations by 2040. This initiative includes collaborations with leading institutions like MIT and Harvard to mitigate the health impacts of fossil fuels. Biogen aims to power operations with renewable energy, transition its fleet to electric vehicles, and support suppliers in reducing fossil fuel usage. This commitment positions Biogen as the first Fortune 500 company to strive for complete fossil fuel independence.

Biogen (NASDAQ: BIIB) announced new data highlighting the effectiveness and safety of its multiple sclerosis (MS) therapies at the MSVirtual2020 conference. Key findings from the Phase 3 study of VUMERITY® (diroximel fumarate) show improved gastrointestinal tolerability compared to TECFIDERA®. In two years, 90% of VUMERITY patients remained free from confirmed disability progression. Real-world studies indicate TYSABRI® (natalizumab) improved quality of life over Ocrevus®. Additionally, PLEGRIDY® and AVONEX® showed benefits in older patients with relapsing MS. Biogen is also advancing BIIB091, a BTK inhibitor for MS treatment.