Biogen presents new data across alzheimer?s disease portfolio at CTAD 2026. Published on 10/29/2026 at 01:05 pm EDT S&P Capital IQ Biogen presented new data across its Alzheimer?s disease portfolio at the 19th Clinical Trials on Alzheimer?s Disease Conference, taking place November 16?19, 2026, at the Boston Marriott Copley Place in Boston, Massachusetts. Presentations included expanded data from the Phase 2 CELIA study evaluating diranersen, an investigational tau-targeting antisense oligonucleotide (ASO), and new analyses from studies of lecanemab (brand name: LEQEMBI). Diranersen is an investigational ASO designed to target MAPT mRNA and reduce the production of all tau isoforms, lowering both intracellular and extracellular tau protein. At CTAD, Biogen presented clinical, biomarker and safety data that build on results previously reported in July 2026 and further characterize the clinical, biomarker and safety profile of diranersen in the Phase 2 CELIA study in early Alzheimer's disease. The late breaking symposium featured three analyses from CELIA, including 96-week long-term extension efficacy and safety data, additional 76-week tau biomarker and amyloid PET data, and 76-week item analyses and select subgroup efficacy data. These data build on previously reported CELIA results and further characterize the clinical, biomarker and safety profile of diranersen in early Alzheimer's disease. Featured lecanemab sessions at CTAD highlighted continued real-world evidence generation and long-term outcomes data related to the treatment of early Alzheimer?s disease. The LEADER study featured new real-world evidence, including findings on lecanemab utilization and outcomes from treatment initiation through maintenance therapy, sex-based outcomes, and experience with at-home subcutaneous lecanemab administration across diverse U.S. clinical settings. The oral presentation reported initial findings through five years of the Clarity AD open-label extension, including long-term clinical outcomes, disease progression and safety with continued lecanemab treatment in early Alzheimer's disease. Additional oral and poster presentations at CTAD highlighted Biogen?s ongoing efforts to advance Alzheimer?s disease diagnosis, treatment and care, including real-world experience with lecanemab, approaches to patient identification and testing, treatment outcomes, and analyses modeling the potential broader impact of slowing disease progression. Diranersen (BIIB080) is an investigational antisense oligonucleotide (ASO) therapy designed to target microtubule-associated protein tau (MAPT) mRNA to reduce the production of tau protein. Abnormal accumulation of tau in the brain is a hallmark of Alzheimer?s disease associated with neurodegeneration and cognitive decline. Diranersen is being investigated as a potential treatment for early Alzheimer?s disease. In 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to diranersen for the treatment of Alzheimer?s disease. In December 2019, Biogen exercised a license option with Ionis Pharmaceuticals and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize diranersen. CELIA is a global Phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and tolerability of diranersen in individuals with early Alzheimer?s disease. The study enrolled 416 participants with mild cognitive impairment due to Alzheimer?s disease or mild Alzheimer?s disease dementia. All participants enrolled in CELIA had not previously received anti-amyloid therapy. The study evaluated three doses of diranersen administered intrathecally over an 18-month placebo-controlled treatment period: 60 mg every six months, 115 mg every six months, and 115 mg every three months. The primary endpoint of CELIA was assessment of dose response for change from baseline on the Clinical Dementia Rating?Sum of Boxes (CDR-SB) at Week 76. Secondary and exploratory endpoints included additional clinical, biomarker and imaging measures, including cerebrospinal fluid tau biomarkers and tau positron emission tomography (PET). An ongoing long-term extension (LTE) study is continuing to evaluate the long-term safety, tolerability and durability of diranersen in early Alzheimer?s disease. Lecanemab is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous maintenance dosing with treatment every four weeks was approved in 9 countries including the U.S., China, the UK, and others, and applications have been filed in 11 countries and regions. The U.S. FDA approved Eisai?s Biologics License Application (BLA) for subcutaneous maintenance dosing (360 mg) with LEQEMBI IQLIK in August 2025. For subcutaneous initiation treatment (500 mg), approval was obtained in the U.S. in July 2026 and China in September 2026, and applications are under review in 2 countries. Eisai and Biogen have been collaborating on the joint development and commercialization of Alzheimer?s disease treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally, with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. (C) S&P Capital IQ - 2026

Biogen shares closed at $244.05, down 3.4%, after the company reported a third-quarter loss of $20.6m, against a profit of $466.5m a year earlier. Loss per share was $0.14, compared with earnings of $3.18. Revenue rose about 11% to $2.8b from $2.53b. Free cash flow reached $600m. Acquired in-process R&D and milestone charges drove the loss, along with higher operating spending tied to Apellis and late-stage trials. Non-GAAP core operating expenses rose 27%. Newer medicines led revenue growth, including those for Alzheimer's, nephrology, and rare disease. They now make up most of Biogen's core pharmaceutical revenue as it moves away from its multiple sclerosis focus.

CEO Innovation policy update 10.29.26. Oct 29, 2026 MassBio CEO & President Kendalle Burlin O'Connell originally posted this update to LinkedIn: MassBio Back on the Hill: Its team was in Washington on Wednesday for meetings with the offices of Sens. Ed Markey and Elizabeth Warren and Reps. Katherine Clark and Lori Trahan, along with Rep. Morgan Griffith (R-Va.), and the Republican Study Committee. Its message was that small and emerging biotechs, which make up most of its membership and are where America's next medicines start, need funding, speed, and certainty from Washington. MassBio asked Congress to fund NIH at no less than FY2026's $48.7 billion, keep opposing OMB's proposal to let political appointees decide which science gets funded, reauthorize PDUFA on time with FDA staffing that keeps pace, and pair sound protections against China with incentives that keep U.S. companies competitive. That evening, MassBio was proud to be a sponsor of the FNIH Celebration of Science, where Cambridge-based Biogen was among this year's Charles A. Sanders, MD, Partnership Award recipients. Treasury Releases Proposed COINS Act Regulations: Last week, the Treasury Department released proposed regulations implementing the Comprehensive Outbound Investment National Security (COINS) Act, including sweeping new restrictions on U.S. investment in Chinese biotechnology. The proposal would cover a broad range of technologies, including drug development, genetic sequencing, and biomanufacturing, and could prohibit certain equity investments, financing arrangements, and joint ventures. Traditional licensing agreements generally remain outside the scope of the proposed restrictions. MassBio is reviewing the proposal closely and intends to submit comments emphasizing the importance of protecting national security without undermining U.S. biotech competitiveness or limiting opportunities to bring promising discoveries into the American drug development pipeline. MassBio welcome perspectives from member companies on potential implications for their businesses ahead of the December 7 comment deadline. Auchincloss and Griffith Unveil Bipartisan Clinical Trials Legislation: Reps. Jake Auchincloss (D-Mass.) and Morgan Griffith (R-Va.) introduced the Faster Clinical Trials Act, a bipartisan proposal aimed at reducing barriers that slow clinical research in the United States. The legislation would establish a new Center for Clinical Trial Innovation at FDA, expand clinical trial networks into community healthcare settings, streamline review of lower-risk Phase 1 trials, and encourage greater use of AI and alternative testing methods. It would also strengthen FDA's Rare Disease Innovation Hub and address common causes of clinical holds. For Massachusetts' emerging biotechs, the proposal represents a potentially significant step toward making clinical trials faster, more predictable, and easier to conduct domestically, and MassBio looks forward to working with Representatives Auchincloss and Griffith in the months ahead. FDA and CMS Announce New Steps to Advance Gene Therapies: On Tuesday, HHS announced two initiatives aimed at accelerating development and improving access to cell and gene therapies. FDA issued draft guidance establishing a more flexible approval framework for individualized genome-editing treatments, allowing multiple patient-specific variations to be covered under a single application and potentially reducing the need for additional clinical trials. Separately, CMS announced plans to expand its Cell and Gene Therapy Access Model beyond sickle cell disease, allowing more manufacturers to participate in negotiated, outcomes-based Medicaid payment arrangements. Together, the initiatives could provide greater regulatory clarity for developers of personalized therapies while addressing longstanding challenges around patient access and reimbursement. FDA Expedited IND Pilot Application Deadline Approaches: FDA's Expedited Investigational New Drug (IND) Pilot Program closes applications tomorrow, October 30. Part of Operation TrialBlazer, the pilot is designed to accelerate first-in-human clinical trials by pairing drug sponsors with qualified research institutions that can provide early regulatory and scientific support. Selected participants will be able to submit components of their IND applications on a rolling basis, potentially identifying and resolving issues earlier in development. FDA expects to select eight to ten sponsor-institution partnerships for the initial cohort. The pilot is particularly relevant to smaller biotechs seeking to reduce development timelines and navigate FDA requirements with limited internal regulatory resources. FDA Seeks Input on Rare Disease Regulatory Reform: FDA convened a public meeting Wednesday to gather stakeholder feedback on its new Rare Disease Framework Initiative. The effort seeks to establish a more flexible, disease-specific approach to regulatory review, recognizing the challenges of generating traditional clinical evidence in small patient populations. FDA is particularly interested in improving the consistency of regulatory expectations, earlier engagement with sponsors and patients, and more tailored manufacturing requirements. Public comments are being accepted through December 11.