Biogen Inc. - BIIB STOCK NEWS

Eisai and Biogen announced that the FDA has accepted their Biologics License Application (BLA) for LEQEMBI subcutaneous autoinjector for weekly maintenance dosing in early Alzheimer's disease treatment. The PDUFA action date is set for August 31, 2025.

If approved, LEQEMBI will be the only Alzheimer's treatment offering subcutaneous administration at home via autoinjector, with injections taking approximately 15 seconds. The treatment would require completion of an initial biweekly intravenous phase before transitioning to weekly subcutaneous maintenance doses.

LEQEMBI is currently approved in multiple countries including the US, Japan, China, and received a positive CHMP opinion in Europe. The FDA is also reviewing a separate application for monthly IV maintenance dosing with a PDUFA date of January 25, 2025.

Sage Therapeutics (SAGE) has received an unsolicited, nonbinding acquisition proposal from Biogen (BIIB) to purchase all outstanding shares not already owned by Biogen at $7.22 per share. The Sage Board of Directors, along with independent financial and legal advisors, will review and evaluate the proposal to determine the best course of action for the company and its shareholders. The company emphasized that there is no guarantee of a transaction resulting from this proposal, and shareholders are not required to take any action at this time.

Cardurion Pharmaceuticals has appointed Charlotte (Charlie) Newman as Chief Business Officer. With over 25 years of industry experience, Newman joins from Agios Pharmaceuticals (NASDAQ: AGIO) where she served as CBO leading corporate strategy and business development. Previously, she held strategic roles at Biogen (NASDAQ: BIIB).

In her new role, Newman will lead corporate development, business development, portfolio strategy, and new product planning for Cardurion's cardiovascular drug candidates. At Agios, she was instrumental in portfolio management and focusing on first and best-in-class therapeutics in non-malignant hematology. Her previous experience includes executive positions at Biogen, Provensis , and G.D. Searle and Company.

Eisai and Biogen announced that LEQEMBI® (lecanemab) has received approval from Mexico's COFEPRIS for the treatment of early Alzheimer's disease (AD). LEQEMBI is the first approved treatment demonstrated to reduce disease progression rate and slow cognitive decline by targeting soluble Aβ aggregates and reducing both Aβ protofibrils and plaques in the brain.

The approval is supported by the global Phase 3 Clarity AD study, which met its primary and key secondary endpoints with statistically significant results. Mexico has approximately 1.3 million people affected by AD, representing 60-70% of all dementia cases. LEQEMBI is already approved and marketed in several countries including the U.S., Japan, China, and others.

Eisai and Biogen have launched LEQEMBI® in South Korea following its approval by the Ministry of Food and Drug Safety in May 2024. The drug is approved for treating adult patients with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia. LEQEMBI is the first approved treatment that reduces disease progression by targeting soluble and insoluble Aβ aggregates in the brain.

South Korea has approximately 900,000 dementia patients, with AD accounting for 70% of cases. The average annual care costs per dementia patient are estimated at 21.1 million South Korean Won, rising to 33.1 million Won for severe cases. Eisai Korea Inc. will handle distribution and launch the drug in the private market, including establishing a Patient Assistance Program.

Biogen (BIIB) and UCB presented Phase 3 PHOENYCS GO study results for dapirolizumab pegol (DZP) in systemic lupus erythematosus (SLE). The study met its primary endpoint with DZP showing a 14.6% higher response rate (49.5%) compared to standard of care (34.6%). Key secondary endpoints demonstrated significant improvements, including 50% fewer severe disease flares and 17.1% more participants achieving corticosteroid dose reduction. The safety profile was generally favorable, with 82.6% of DZP patients experiencing treatment-emergent adverse events versus 75% in the control group. A second Phase 3 trial, PHOENYCS FLY, will be initiated in 2024.

Eisai and Biogen received a positive opinion from the European Medicines Agency's CHMP for lecanemab, recommending its approval for treating early Alzheimer's disease in adult patients with specific genetic profiles. This follows a re-examination of a previous negative opinion from July 2024. The treatment targets amyloid-beta aggregates in the brain, potentially slowing disease progression. The European Commission's final decision is expected within 67 days. Alzheimer's disease affects approximately 6.9 million people in Europe, with numbers projected to double by 2050.

Eisai and Biogen received a positive opinion from the European Medicines Agency's CHMP for lecanemab in treating early Alzheimer's disease. The treatment is recommended for adult patients with mild cognitive impairment and mild dementia due to Alzheimer's, specifically for ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology. The European Commission's final decision is expected within 67 days. In clinical trials, lecanemab showed a 31% reduction in clinical decline compared to placebo at 18 months, and demonstrated a 33% less decline in daily living activities. The drug is already approved in several countries including the U.S., Japan, and China.

Eisai has completed a rolling Biologics License Application (BLA) submission to the FDA for LEQEMBI® subcutaneous autoinjector for weekly maintenance dosing in early Alzheimer's disease treatment. The submission, under Fast Track designation, is based on data from the Clarity AD open-label extension study. If approved, patients could self-administer LEQEMBI at home in approximately 15 seconds after completing the initial biweekly intravenous phase. The autoinjector option aims to maintain effective drug concentrations while offering greater convenience compared to IV administration.