Biogen Inc Stock Price, News & Analysis

Biogen has announced a private Exchange Offer to swap $1.75 billion of its 5.200% Senior Notes due 2045 for new notes and cash. This offer is available only to "Eligible Holders" who meet specific qualifications. The Exchange Offer will expire on February 10, 2021, and cash payments will be included in the Total Exchange Consideration. Concurrently, Biogen is offering a cash tender to Ineligible Holders. Conditions apply, including a minimum issue amount of $300 million for New Notes. The complete terms are outlined in the Offering Memorandum.

Biogen has received FDA approval for the intramuscular (IM) administration of PLEGRIDY (peginterferon beta-1a) to treat relapsing multiple sclerosis (MS), which is expected to reduce injection site reactions significantly. This follows European Commission authorization in December 2020. PLEGRIDY is already known for its efficacy in reducing relapses and delaying disability progression. The approval was based on studies showing that IM administration resulted in fewer injection site reactions compared to the subcutaneous method (14.4% vs. 32.1%). This adds to Biogen's extensive MS treatment options in over 60 countries.

The FDA has extended the review period for Biogen's aducanumab, a treatment for Alzheimer's, by three months, setting the new PDUFA action date to June 7, 2021. This extension follows Biogen's submission of additional clinical data considered a Major Amendment. Aducanumab, developed in collaboration with Eisai, aims to alter disease progression and improve daily living activities for Alzheimer’s patients. The drug, licensed from Neurimmune, could become the first effective treatment for Alzheimer’s if approved.

Biogen announces a multi-year virtual research study in collaboration with Apple to explore digital biomarkers for monitoring cognitive performance and detecting mild cognitive impairment (MCI). Set to launch in 2021, the study will enroll diverse participants to enhance understanding of cognitive health through Apple technology. MCI affects approximately 15-20% of adults over 65, but diagnosis often faces delays. The initiative aims to empower patients and healthcare providers by accelerating diagnoses and improving health outcomes while ensuring participant data privacy and security.

Biogen (Nasdaq: BIIB) has launched the Phase 4 RESPOND study to assess the efficacy and safety of SPINRAZA in children with spinal muscular atrophy (SMA) who have had suboptimal responses to Zolgensma. The study will include around 60 patients across 20 sites globally. It aims to explore if SPINRAZA can provide additional benefits by increasing survival motor neuron (SMN) protein production in previously treated patients. The two-year study will focus on various clinical endpoints, including motor function and safety.

Biogen has received European Commission approval for PLEGRIDY® (peginterferon beta-1a) for intramuscular (IM) injection, increasing treatment options for patients with relapsing multiple sclerosis (MS). This new route offers a reliable treatment option with a well-characterized safety profile and fewer injection site reactions compared to subcutaneous (SC) administration (14.4% vs. 32.1%). PLEGRIDY is already available in over 60 countries, and Biogen is pursuing similar regulatory approval in the U.S. This enhances Biogen's comprehensive MS portfolio aimed at meeting diverse patient needs.

Biogen has submitted a New Drug Application (J-NDA) for aducanumab to Japan's Ministry of Health, Labor and Welfare. If approved, aducanumab would be the first treatment to significantly alter the course of Alzheimer’s disease. The drug targets amyloid beta and has shown promise in clinical trials for slowing clinical decline in patients with Mild Cognitive Impairment and mild Alzheimer's disease dementia. Aducanumab is also undergoing regulatory reviews in the U.S. and Europe, with the FDA expected to make a decision by March 7, 2021.

Biogen and Sage Therapeutics have entered a global collaboration to jointly develop and commercialize zuranolone and SAGE-324 for various mental health disorders and essential tremor in the U.S. Biogen will also have an exclusive license for zuranolone outside the U.S., excluding certain Asian markets. Sage will receive $1.525 billion in cash, including an $875 million upfront payment and a $650 million equity investment. The collaboration aims to address the unmet medical needs in depression, with potential milestone payments of up to $1.6 billion.

On November 18, 2020, Samsung Bioepis and Biogen announced that the FDA accepted the Biologics License Application for SB11, a biosimilar to Lucentis® (ranibizumab), aimed at treating retinal vascular disorders, a leading cause of blindness in the U.S.

This milestone could significantly improve access to affordable therapies, with projected savings exceeding $100 billion over five years from biosimilars in the U.S. If approved, SB11 is expected to help millions of patients.