Biogen's Strategic Direction - Biogen is broadening its portfolio across Neuro, Immunology & Rare Disease, aiming for long-term sustainable growth[4,17] - Approximately 50% of Biogen's total company revenue is projected to come from outside of MS, including Biosimilars[17] Felzartamab's Potential in Nephrology - Felzartamab targets CD38-expressing cells, offering a differentiated approach for antibody-mediated diseases[27,29] - Phase 3 programs for Felzartamab are underway, targeting Antibody Mediated Rejection (AMR), IgA Nephropathy (IgAN), and Primary Membranous Nephropathy (PMN)[106] Antibody Mediated Rejection (AMR) - Late AMR affects approximately 11,000 patients in the U S, with >75% transplant loss and a median graft survival of ~2 years after diagnosis[36,37,40] - In a Phase 2 study, Felzartamab treatment resulted in >80% biopsy late AMR resolution at week 24, compared to 20% in the placebo group[53] - A Phase 3 study for Felzartamab in late AMR is underway, with data expected in 2027[56] IgA Nephropathy (IgAN) - IgAN affects approximately 130,000 patients in the U S, with up to 40% of patients reaching end-stage kidney disease within 20 years of diagnosis[61] - Phase 2 data showed that with 5 months of Felzartamab treatment, patients had sustained clinical benefit out to 2 years, with ~50% UPCR reduction at 24 months in the 9-dose group[69,71] - A Phase 3 study for Felzartamab in IgAN is designed to demonstrate improvement in kidney function, with data expected in 2029[74] Primary Membranous Nephropathy (PMN) - PMN affects approximately 36,000 patients in the U S, with up to 40% progressing to end-stage kidney disease within 15 years[80,81,103] - Phase 2 data showed robust and sustained reductions in anti-PLA2R and improvements in both newly diagnosed/relapsed (NDR) and refractory PMN patients[103] - A Phase 3 study for Felzartamab in PMN is designed to demonstrate complete remission of proteinuria, with data expected in 2029[100]

Global Healthcare Biopharma catalysts to watch in 3Q25 With macroeconomic volatility and healthcare policy uncertainty persisting likely into the back half of the year, we continue to advocate for and highlight idiosyncratic catalysts with attractive risk/reward setups to drive alpha generation. Herein, we highlight and preview key catalysts in 3Q25 across the GS biotechnology coverage universe from pivotal studies: BMY's Cobenfy ADEPT-2 in Alzheimer's disease psychosis; LLY's orforglipron ATTAIN-1 in obesi ...

Japan Equity Research June 20, 2025 Pharmaceutical Sector Data Book – Valuation, Product Sales Trend Biotechnology & Pharmaceuticals/ Medical Technologies & Services Seiji Wakao, Ph.D. AC seiji.wakao@jpmorgan.com (81-3) 6736-8612 | | | | | P/E(x) | | | | | | P/B(x) | | | | | | EV/EBITDA(x) | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | FY25E | FY26E | FY27E | FY28E | FY29E | FY35E | FY25E | FY26E | FY27E | FY28E | FY29E ...

据报道，这家总部位于印第安纳州的制药巨头表示，鉴于公司、临床专家及患者权益组织提交的数据， NICE的推荐决定有失公允，公司将就此提出上诉。 据了解，2024年，英国药品与保健品管理局(MHRA)已批准Leqembi和Kisunla用于治疗轻度阿尔茨海默 病成人患者。但在获批后不久，NICE即发布草案指南，拒绝将这两种疗法纳入NHS报销范围。 英国国家健康与护理卓越研究院(NICE)周四发布的最终指导草案中明确表示，礼来的Kisunla以及渤健 (BIIB.US)与卫材(ESALF.US)的竞争产品Leqembi均不应在英国国民医疗服务体系(NHS)内使用。NICE负 责为英国NHS制定药品政策。 NICE指出，经过对先前否定性草案建议的重新评估，其独立专家委员会认定这两种靶向淀粉样蛋白抗 体的临床效益"仍不足以证明其给NHS带来的额外成本是合理的"。 该机构在声明中强调："今日发布的最终指导草案中，委员会维持原有结论——这两种药物均不推荐用 于治疗由阿尔茨海默病引起的轻度认知障碍或轻度痴呆。" （原标题：礼来(LLY.US)将就英国拒绝推荐其新型阿尔茨海默病药物决定提起上诉） 智通财经APP获悉，礼来(LL ...

Core Viewpoint - Sanofi has agreed to acquire Vigil Neuroscience for approximately $470 million, enhancing its neurology pipeline with the addition of VG-3927, an investigational treatment for Alzheimer's disease [1][4]. Group 1: Acquisition Details - The acquisition involves Sanofi purchasing all outstanding shares of Vigil at $8 per share in cash, with Vigil shareholders also eligible for a contingent value right of $2 per share upon the first sale of VG-3927 [3]. - The transaction is expected to close in the third quarter of 2025, subject to customary closing conditions, and will not affect Sanofi's financial guidance for 2025 [4]. Group 2: Product Information - VG-3927 is a TREM2 agonist aimed at enhancing the neuroprotective function of microglia in Alzheimer's patients, differing from existing FDA-approved drugs that target amyloid beta plaque accumulation [2][8]. - Sanofi is not acquiring Vigil's other candidate, iluzanebart (VGL101), which is in mid-stage development for a rare neurodegenerative disease [5]. Group 3: Market Context - Year-to-date, Sanofi's shares have increased by 9.7%, contrasting with a 3.9% decline in the industry [2]. - Currently, there are two FDA-approved drugs for Alzheimer's disease: Biogen's Leqembi and Eli Lilly's Kisunla, both targeting amyloid beta accumulation [8][9].

Biogen (BIIB) reported first-quarter 2025 adjusted earnings per share (EPS) of $3.02, which missed the Zacks Consensus Estimate of $3.32.Earnings declined 18% year over year on a reported basis, owing to costs related to an upfront payment of $165 million made to Stoke Therapeutics (STOK) . BIIB entered into a collaboration agreement with STOK for the development and commercialization of the latter’s pipeline candidate, zorevunersen for treating Dravet syndrome in February. (Find the latest EPS estimates an ...

Biogen (BIIB) will report first-quarter 2025 results on May 1, before market open. In the last reported quarter, the company's earnings beat expectations by 0.58%. The Zacks Consensus Estimate for first-quarter sales and earnings is pegged at $2.24 billion and $3.34 per share, respectively. (Find the latest earnings estimates and surprises on Zacks Earnings Calendar.)Factors to Consider for BiogenIn the first quarter, lower sales of multiple sclerosis (“MS”) drugs are likely to have been offset by revenues ...

Core Insights - Lecanemab has received Marketing Authorization in the EU, marking it as the first therapy targeting the underlying cause of Alzheimer's disease to be approved in this region [1][2] - The treatment is specifically indicated for adult patients with mild cognitive impairment and mild dementia due to Alzheimer's disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology [1][2] - The approval applies to all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway [1][3] Company Overview - Eisai Co., Ltd. and Biogen Inc. are collaborating on the development and commercialization of lecanemab, with Eisai leading the global development and regulatory submissions [2][8] - The approval of lecanemab in the EU is the thirteenth approval globally, following its benefits to thousands of patients in the U.S., Japan, and other regions [2][6] - Eisai aims to work with national reimbursement authorities and healthcare providers to ensure access to lecanemab for eligible patients as soon as possible [2] Clinical Data - The authorization was based on Phase 3 data from the Clarity AD clinical trial, which involved 1,795 patients with early Alzheimer's disease [4][6] - In the trial, lecanemab reduced clinical decline on the CDR-SB scale by 31% at 18 months compared to placebo [4][6] - The secondary endpoint showed a 33% less decline in daily living activities for patients treated with lecanemab compared to placebo [4][6] Market Context - Alzheimer's disease currently affects an estimated 15.2 million people with mild cognitive impairment and 6.9 million with mild dementia in Europe, indicating a significant unmet need for effective treatments [1][6] - Lecanemab is the only approved Aβ monoclonal antibody that preferentially binds and clears toxic protofibrils, which are key contributors to neuronal injury in Alzheimer's disease [1][4] - The approval of lecanemab represents a landmark advancement in a field that has seen little innovation over the past two decades [2][6]