Biogen Inc Stock Price, News & Analysis

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.

Biogen (NASDAQ:BIIB) and Eisai presented new four-year clinical data for LEQEMBI® (lecanemab-irmb) in early Alzheimer's disease treatment at AAIC 2025. The data demonstrated that continuous LEQEMBI treatment slowed clinical decline by 1.75 points on the CDR-SB scale compared to natural disease progression.

Among patients with low tau levels, indicating earlier-stage disease, 69% showed improvement or no decline, and 56% demonstrated improved cognitive and daily living function after four years of treatment. The study involved 478 patients receiving treatment for four years, with consistent safety profiles and decreased ARIA rates after the initial 12 months.

LEQEMBI's dual mechanism targets both amyloid plaque and protofibrils, potentially impacting tau downstream. The drug showed increasing benefits over time, with a 2.17-point reduction in cognitive decline compared to the BioFINDER cohort at four years.

Biogen (NASDAQ:BIIB) announced that ZURZUVAE® (zuranolone) received a positive recommendation from the European Medicines Agency's CHMP for treating postpartum depression (PPD) in adults following childbirth. If approved by the European Commission, ZURZUVAE will become the first specifically-indicated PPD treatment in the European Union.

The recommendation is based on the successful SKYLARK Study, which demonstrated significant reduction in depressive symptoms as early as Day 3, with benefits sustained through Day 45 compared to placebo. ZURZUVAE, a once-daily oral 14-day treatment, was previously approved by the FDA in 2023 and classified as a Class IV controlled substance.

PPD affects an estimated 5-20% of women with pregnancy in Europe, representing a significant unmet medical need. The European Commission's final decision is expected in Q3 2025.

Biogen (NASDAQ:BIIB) announced upcoming presentations at the 2025 Alzheimer's Association International Conference (AAIC) in Toronto from July 27-31. The company will present key data on LEQEMBI® (lecanemab), including 48-month results from the Clarity AD open-label extension and insights into a new subcutaneous formulation for maintenance dosing.

The presentations will also feature tau-related research, including baseline characteristics from the CELIA Phase 2 trial of BIIB080, an investigational antisense oligonucleotide therapy targeting tau. Additionally, Biogen will showcase real-world evidence, treatment comparisons, and host an educational program on tau in Alzheimer's disease through an interactive booth and e-learning resources.