Biogen Inc Stock Price, News & Analysis

Eisai and Biogen provided an update on the regulatory review of lecanemab for early Alzheimer's disease in the European Union. Following a positive CHMP opinion in November 2024, the European Commission has requested the CHMP to review new safety information that emerged after the initial opinion and evaluate if risk minimization measures are clearly worded.

The companies report that lecanemab's safety profile in clinical practice across the US, Japan, and other markets remains consistent with approved labels, with no new safety signals identified. They believe existing information can address the EC's requests, which will be discussed at the February 2025 CHMP meeting.

Eisai leads the global development and regulatory submissions for lecanemab, with both companies co-commercializing and co-promoting the product. Eisai maintains final decision-making authority.

Sage Therapeutics (NASDAQ: SAGE) has announced that its Board of Directors has initiated a process to explore strategic alternatives, including potential strategic transactions, business combinations, or sale. The Board has unanimously rejected an unsolicited, nonbinding proposal from Biogen (NASDAQ: BIIB) to acquire all outstanding shares not already owned by Biogen for $7.22 per share, received on January 10, 2025.

The Board concluded that Biogen's proposal significantly undervalues Sage and is not in shareholders' best interests. While conducting the strategic review, Sage remains focused on establishing ZURZUVAE as the standard of care for women with postpartum depression (PPD). The company has not set a timetable for the review process and has not made any decisions regarding potential strategic alternatives.

Biogen (BIIB) and Eisai announced FDA approval for LEQEMBI's intravenous maintenance dosing schedule change from every two weeks to every four weeks for early Alzheimer's disease treatment. After 18 months of bi-weekly initiation phase, patients can transition to the four-week maintenance schedule or continue bi-weekly treatment.

The approval is supported by modeling data from Phase 2 and Clarity AD studies, predicting maintained clinical benefits with the new dosing regimen. LEQEMBI works by clearing both protofibrils and plaque, with data showing that treatment discontinuation leads to biomarker reaccumulation and clinical decline reversion.

The treatment demonstrated significant clinical benefits, reducing cognitive decline on the CDR-SB scale by -0.95 over three years compared to a matched natural history cohort. LEQEMBI is currently approved in multiple countries, including the US, Japan, and China, with pending applications in 17 other regions.

Biogen (BIIB) announced that both the FDA and EMA have accepted applications for a higher dose regimen of nusinersen for treating spinal muscular atrophy (SMA). The new proposed regimen includes a faster loading schedule with two 50 mg doses given 14 days apart, followed by 28 mg maintenance doses every 4 months. This is an increase from the currently approved SPINRAZA® dosing of 12 mg, which is available in over 71 countries.

The applications are supported by data from the DEVOTE study, which demonstrated potential benefits of the higher dose regimen while maintaining a safety profile consistent with the current 12 mg dosing. The development represents Biogen's ongoing commitment to advancing treatment options for SMA patients.

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.