Biogen Inc Stock Price, News & Analysis

Biogen Inc. (Nasdaq: BIIB) and Eisai have announced a negative opinion from the CHMP regarding the Marketing Authorization Application for aducanumab, aimed at treating early-stage Alzheimer’s disease. This follows a prior negative vote in November 2021. Biogen will seek a re-examination to address the committee's concerns. The MAA included data from a multi-study program involving approximately 3,600 patients across over 20 countries. Notably, ADUHELM received accelerated approval from the FDA in June 2021. The situation reflects ongoing challenges in Alzheimer's treatment approval.

Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. announce progress on the Phase 4 post-marketing confirmatory study of ADUHELM (aducanumab-avwa) for Alzheimer’s disease. The final protocol will be submitted to the FDA by March 2022, followed by patient screening in May 2022. The global, placebo-controlled trial aims to enroll over 1,300 patients with an expected primary completion in four years. This study is a requirement of the FDA's accelerated approval for ADUHELM, which targets amyloid beta plaques in Alzheimer’s patients.

Biogen (Nasdaq: BIIB) has announced a collaboration with TheraPanacea to utilize machine learning and artificial intelligence in neurology. This partnership aims to enhance patient care, streamline drug development, and deepen understanding of neurological diseases. Biogen will invest up to $15 million and can earn up to $41 million in milestone payments based on R&D achievements. The collaboration grants Biogen exclusive rights to TheraPanacea's technology in neuroscience, promoting a new era in personalized medicine.

Sage Therapeutics and Biogen announced promising results from their clinical program for zuranolone, an investigational treatment for major depressive disorder (MDD). In the WATERFALL Study, patients receiving 50 mg zuranolone showed rapid improvements in depressive symptoms as early as Day 3, with effects maintained through Day 42. Safety profiles were consistent with previous studies, showing no increase in adverse events typical of existing antidepressants. Results for older patients (65+) were similarly favorable. These findings were presented at the American College of Neuropsychopharmacology Congress.

Sage Therapeutics and Biogen have announced positive 12-month results for zuranolone 50 mg in the ongoing Phase 3 SHORELINE Study. The study included 199 patients with major depressive disorder (MDD), demonstrating that 74.9% responded to the initial treatment. Zuranolone was well-tolerated, with 68.8% reporting adverse events, mostly mild to moderate. Approximately 80% of responders received just one or two treatment courses over a year, showcasing the drug's potential for quick symptom relief without frequent dosing.

On November 17, 2021, Biogen and Eisai announced a negative trend vote regarding their Marketing Authorization Application for aducanumab (100 mg/mL) for Alzheimer’s treatment by the European Medicines Agency's CHMP. Following an oral explanation, a formal opinion is expected by December 16, 2021. Biogen emphasized its belief in the data supporting aducanumab, citing new Phase 3 findings that suggest it effectively reduces amyloid beta plaques. The drug is already approved in the U.S. under accelerated conditions, pending further confirmatory trials.

Biogen has received marketing authorization from the European Commission for VUMERITY (diroximel fumarate), a next-generation oral treatment for adults with relapsing-remitting multiple sclerosis (MS). The approval builds on Biogen's reputation in MS therapies and follows similar authorizations in the U.S., Great Britain, and Switzerland. Data from Phase 3 trials indicate that VUMERITY has a favorable gastrointestinal tolerability profile, resulting in lower discontinuation rates compared to TECFIDERA. The launch aims to provide patients flexibility in treatment adherence amid the ongoing COVID-19 pandemic.

Biogen (Nasdaq: BIIB) announced that Dr. Alfred Sandrock, Head of Research & Development, will retire on December 31, 2021, after 23 years with the company. He has spearheaded the development of key therapies such as Tysabri, Tecfidera, Spinraza, and Aduhelm. Priya Singhal will serve as interim Head of Research & Development until a permanent successor is found. Biogen's CEO and Board acknowledged Dr. Sandrock's significant contributions, emphasizing his impact on R&D and the company's growth.