Biogen Inc Stock Price, News & Analysis

Eisai and Biogen (NASDAQ:BIIB) have initiated a rolling Supplemental Biologics License Application (sBLA) to the FDA for LEQEMBI IQLIK, a subcutaneous autoinjector formulation of lecanemab-irmb, under Fast Track Status. This new formulation would allow at-home administration of LEQEMBI from the start of treatment for early Alzheimer's disease patients.

The autoinjector would enable a weekly starting dose of 500mg (two 250mg injections) as an alternative to bi-weekly intravenous dosing. Each injection takes approximately 15 seconds to administer. If approved, LEQEMBI IQLIK would be the first anti-amyloid treatment offering at-home injection from initiation through maintenance, potentially reducing healthcare resource utilization.

LEQEMBI is currently approved in 48 countries and under review in 10 others. The drug uniquely targets both amyloid plaque and protofibrils in Alzheimer's disease treatment.

Biogen (NASDAQ:BIIB) and Stoke Therapeutics presented promising data for zorevunersen, potentially the first disease-modifying treatment for Dravet syndrome, at the 36th International Epilepsy Congress. The Phase 1/2a and open-label extension studies showed significant results over three years, including:

Patients receiving 70mg doses demonstrated an 84.8% median reduction in seizures and gained eight additional seizure-free days per 28-day period. The drug showed durable efficacy with 77% (58/75) of patients remaining in the studies after three years, exhibiting sustained seizure reduction and improved quality of life.

Safety data from 81 treated patients showed zorevunersen was generally well-tolerated, with CSF protein elevations being the most common treatment-related adverse event. These results support the ongoing Phase 3 EMPEROR study.

Biogen (NASDAQ:BIIB) and Eisai announced FDA approval of LEQEMBI IQLIK, a subcutaneous autoinjector for maintenance treatment of early Alzheimer's disease. The device delivers a 360 mg weekly injection in approximately 15 seconds, offering an at-home alternative after 18 months of initial IV treatment.

Clinical trials demonstrated that transitioning to the weekly autoinjector maintained comparable benefits to IV dosing, with improved safety profile showing less than 1% systemic reactions compared to 26% with IV infusions. The device will launch on October 6, 2025, in the U.S., supported by patient assistance programs and dedicated navigators to help with treatment access.

Long-term data showed that at 48 months, LEQEMBI reduced cognitive decline by 1.75-2.17 points on the CDR-SB scale compared to expected natural disease progression.

Eisai and Biogen (NASDAQ:BIIB) announced FDA approval of LEQEMBI IQLIK, the first subcutaneous autoinjector for Alzheimer's disease maintenance treatment. After 18 months of intravenous LEQEMBI, patients can transition to weekly 360mg subcutaneous injections or continue IV dosing every four weeks.

The approval is supported by clinical data from over 600 patients, showing the subcutaneous formulation maintains comparable benefits to IV dosing with improved safety profile - less than 1% systemic reactions compared to 26% with IV. The autoinjector can be administered in approximately 15 seconds at home, offering greater convenience for patients and caregivers.

LEQEMBI IQLIK will launch in the U.S. on October 6, 2025, with comprehensive patient support programs including financial assistance for eligible patients.

Biogen (NASDAQ:BIIB) and Stoke Therapeutics have announced new clinical data presentations for zorevunersen, their investigational treatment for Dravet syndrome, at the upcoming 36th International Epilepsy Congress. The presentations will showcase 3-year data from open-label extension studies demonstrating potential disease-modifying effects.

Key findings include durable seizure reductions, improvements in cognition and behavior, and substantial enhancement in overall seizure burden and seizure-free days. The data supports the ongoing global pivotal EMPEROR Phase 3 study, which is currently enrolling and dosing patients.

Three presentations will detail zorevunersen's clinical outcomes, including improvements in seizure burden and the EMPEROR study design. An additional company presentation will discuss emerging concepts and therapeutics in Dravet syndrome.

Biogen (NASDAQ:BIIB) and Eisai announced the launch of LEQEMBI® (lecanemab) in Austria on August 25, 2025, and upcoming launch in Germany on September 1, 2025, marking the first launches in the European Union. The anti-amyloid beta monoclonal antibody received EC approval in April 2025 for treating early Alzheimer's disease in specific patient populations.

LEQEMBI demonstrated significant efficacy in the Clarity AD trial, showing a 31% reduction in clinical decline at 18 months compared to placebo in the EU-indicated population. The treatment is specifically indicated for adult patients with mild cognitive impairment and mild dementia due to Alzheimer's disease who are apolipoprotein E ε4 non-carriers or heterozygotes with confirmed amyloid pathology.

The launch follows implementation of mandatory controlled access programs in both countries, ensuring appropriate use and patient safety. Eisai leads the development and regulatory submissions globally, with both companies co-commercializing the product in the EU.

Biogen (NASDAQ:BIIB) and Stoke Therapeutics (NASDAQ:STOK) have announced the dosing of the first patient in their global Phase 3 EMPEROR study of zorevunersen, a potential first-in-class disease-modifying treatment for Dravet syndrome.

The pivotal study will enroll patients aged 2-18 years with confirmed SCN1A gene variants. The 52-week trial includes a randomized 1:1 treatment arm receiving zorevunersen (two 70mg loading doses followed by two 45mg maintenance doses) versus sham control. The primary endpoint measures change in major motor seizure frequency at Week 28, with key secondary endpoints including seizure frequency at Week 52 and changes in behavior and cognition.

Dravet syndrome is a rare genetic disease characterized by refractory seizures and neurodevelopmental impairments, with no currently approved treatments addressing its underlying cause. The study is being conducted in the US, UK, Japan, and planned for Europe.

Biogen (NASDAQ:BIIB) and Eisai presented promising two-year real-world study results for LEQEMBI® in treating early Alzheimer's disease at AAIC 2025. The interim analysis of 178 patients across nine U.S. medical centers showed that 87.4% of patients continued treatment, with 83.6% either remaining stable or showing improvement in their clinical condition.

The study revealed a favorable safety profile with ARIA (amyloid-related imaging abnormalities) observed in only 12.9% of patients, most cases being asymptomatic. Treatment satisfaction scores were notably high, with physicians rating efficacy and safety at 8.7 out of 10. The study also highlighted the increasing adoption of blood-based biomarkers, with 27.5% of patients diagnosed using this method.

Biogen (NASDAQ:BIIB) and Eisai presented new data for LEQEMBI® (lecanemab-irmb) at AAIC 2025, showcasing promising results for a 360mg subcutaneous maintenance dosing option for early Alzheimer's disease treatment. The subcutaneous autoinjector (SC-AI) demonstrated comparable efficacy and safety to the intravenous formulation.

Key findings show that transitioning to weekly 360mg SC-AI after 18 months of IV treatment maintains clinical benefits, with less than 1% systemic injection reactions compared to 26% with IV. Human factors studies revealed 95% successful administration rates, with high satisfaction among patients, caregivers, and healthcare professionals. The FDA has set a PDUFA date of August 31, 2025 for the SC-AI formulation.