Biogen Inc - BIIB STOCK NEWS

Cardurion Pharmaceuticals has appointed Karen Lewis as Chief People Officer, bringing over 25 years of human resources experience to the clinical-stage biotechnology company. Lewis joins from Apellis Pharmaceuticals (APLS), where she served as Chief People Officer and led organizational growth from 200 to over 900 employees globally while supporting the launch of two drug products.

Prior to Apellis, Lewis held leadership positions at Axcella Health, Biogen (BIIB), Amazon, and Bristol-Myers Squibb (BMY). At Biogen, she served as Vice President of Global Talent Acquisition and headed HR for U.S. commercial and Asia Pacific/Latin America operations. Lewis holds a B.S. in biology from Rider University and began her career as a research scientist before transitioning to HR.

Biogen (BIIB) has initiated the Phase 3 TRANSCEND study to evaluate felzartamab for treating late antibody-mediated rejection (AMR) in kidney transplant patients. The study will enroll approximately 120 kidney transplant recipients and compare the drug's efficacy against placebo.

The trial is structured in two parts over 52 weeks: Part A involves nine intravenous infusions over 6 months, with the primary endpoint measuring AMR resolution by biopsy at 6 months. Part B provides all participants with felzartamab for an additional 6 months to evaluate longer-term effects.

AMR affects approximately 23,000 patients in the U.S. and is a leading cause of kidney transplant loss. The study follows promising Phase 2 results, and Biogen plans additional Phase 3 trials for felzartamab in IgA nephropathy and primary membranous nephropathy in 2025. As part of the trial initiation, MorphoSys will receive a $35 million milestone payment from Biogen.

Eisai and Biogen (BIIB) announced that the European Medicines Agency's CHMP has reaffirmed its positive opinion for lecanemab, their anti-Aβ monoclonal antibody treatment for early Alzheimer's disease. This follows the European Commission's January 2025 request to review additional safety information that emerged after the initial November 2024 positive opinion.

The treatment targets an estimated 15.2 million people with mild cognitive impairment due to Alzheimer's and 6.9 million with AD dementia in Europe. If approved by the EC, lecanemab will be available in all 27 EU member states, plus Iceland, Liechtenstein, and Norway.

Lecanemab has already received approval in multiple regions including the US, Japan, China, and South Korea. The FDA recently approved a maintenance dosing schedule of once every four weeks, and a subcutaneous injection formulation is under review to enhance patient convenience.

Biogen and Stoke Therapeutics have entered into a collaboration to develop and commercialize zorevunersen for the treatment of Dravet syndrome, a severe genetic epilepsy. Biogen gains exclusive commercialization rights outside the US, Canada, and Mexico, while Stoke retains rights in these regions. The pivotal Phase 3 EMPEROR study is set to begin in Q2 2025, with results expected in 2H 2027.

Stoke will receive $165M upfront, share development costs, and could earn up to $385M in milestones and royalties. Zorevunersen targets the SCN1A gene, the main cause of Dravet syndrome, and has shown promising results in early trials, reducing seizure frequency and improving cognition and behavior. The drug has received FDA Breakthrough Therapy Designation and will advance to a global Phase 3 study.

This collaboration enhances Biogen's rare disease pipeline and leverages its global commercialization expertise. Dravet syndrome affects up to 38,000 people in the US, UK, EU-4, and Japan, with no current disease-modifying therapies available. The partnership aims to meet significant unmet needs in this patient population.

Biogen and Stoke Therapeutics announced a collaboration for developing and commercializing zorevunersen, a potential first-in-class treatment for Dravet syndrome. Stoke retains rights in US, Canada, and Mexico, while Biogen receives rights for the rest of world.

The deal includes a $165 million upfront payment to Stoke, with potential for $385 million in additional milestones plus tiered royalties. The pivotal Phase 3 EMPEROR study is scheduled to begin in Q2 2025, with results expected in 2H 2027.

Zorevunersen, which targets the SCN1A gene, has received FDA Breakthrough Therapy Designation. Phase 1/2a and open-label extension studies showed substantial reductions in seizure frequency and improvements in cognition and behavior. The treatment addresses an estimated 38,000 patients across the U.S., UK, EU-4, and Japan.

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.