Merck and Japan's Eisai said on Wednesday they will shut down a late-stage study testing an experimental combination therapy to treat a type of liver cancer, after interim results showed the treatment... ...

Core Insights - Merck and Eisai's experimental combination treatment for a type of kidney cancer achieved one of its main goals in a late-stage study [1] Company Summary - Merck and Eisai are collaborating on a combination treatment targeting kidney cancer, indicating progress in their clinical development efforts [1]

Core Insights - Merck and Eisai announced that their combination therapy WELIREG® plus LENVIMA® met the primary endpoint of progression-free survival (PFS) in certain previously treated patients with advanced renal cell carcinoma [1] Group 1 - The combination therapy demonstrated significant efficacy in improving PFS for patients with advanced renal cell carcinoma [1] - This development highlights the ongoing collaboration between Merck and Eisai in the oncology sector [1] - The results may lead to further advancements in treatment options for patients with this type of cancer [1]

Core Insights - Health Canada has granted a Notice of Compliance with Conditions for Leqembi® (lecanemab), marking it as the first treatment for early Alzheimer's disease authorized in Canada targeting the underlying cause of the disease [1][18] - Leqembi has shown significant efficacy in reducing disease progression and cognitive decline in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease [2][7] Company Overview - BioArctic AB and Eisai have a long-standing collaboration since 2005, focusing on the development and commercialization of Alzheimer's disease treatments, with Eisai responsible for clinical development and market applications [5][11] - BioArctic retains commercialization rights for Leqembi in the Nordic region and is preparing for joint commercialization with Eisai [5][11] Clinical Data - The approval of Leqembi is based on the Phase 3 Clarity AD study, which demonstrated statistically significant results in meeting primary and secondary endpoints [3][7] - The Clarity AD study involved 1,795 patients with early Alzheimer's disease, confirming the presence of amyloid pathology, and utilized a bi-weekly dosing regimen of 10 mg/kg for 18 months [7][8] Market Context - Alzheimer's disease accounts for 60 to 80% of all dementia cases, with over 771,000 dementia patients in Canada as of January 1, 2025, projected to rise to approximately 1 million by 2030 [4] - The annual care provided by family and friends for dementia patients is equivalent to 290,000 full-time jobs, expected to increase to 690,000 by 2050 [4] Product Information - Leqembi selectively binds to both soluble and insoluble amyloid-beta aggregates, reducing their presence in the brain, which is crucial for slowing cognitive decline [2][16] - The drug is approved in 51 countries, including the U.S., Japan, and the EU, and is under review in 9 additional countries [2][8]

Core Insights - Biogen's key multiple sclerosis (MS) drugs, including Tecfidera and Tysabri, along with the spinal muscular atrophy (SMA) treatment Spinraza, are experiencing declining sales due to increased competition, impacting overall revenue growth [1][3][10] Sales Performance - Sales of Tecfidera are declining due to the launch of multiple generic versions in North America, Brazil, and certain European countries [3] - Tysabri's sales are also declining as a result of heightened competition in the U.S. and the introduction of biosimilars in Europe, with a U.S. biosimilar expected by Q4 2025 [3][4] - Spinraza's revenues are anticipated to be lower in the second half of the year due to unfavorable shipment timing and competition from Novartis' Zolgensma and Roche's Evrysdi [5] New Drug Developments - Biogen's collaboration with Eisai on Leqembi for Alzheimer's disease shows potential for long-term growth, with sequential sales improvements noted over the past four quarters [6][10] - Leqembi has been launched in multiple countries and is expected to generate significant sales due to the unmet need in Alzheimer's treatment [7] - Skyclarys is witnessing strong demand trends, particularly in the U.S. and EU, with ex-U.S. sales projected to become a more significant growth driver in 2025 [9] Financial Outlook - Biogen's total revenues rose by 7% in the first half of 2025, driven by new drug sales, although the overall revenue for 2025 is projected to remain flat compared to 2024 [11][12] - The contribution from new drugs is increasing, but it is not yet sufficient to offset the declining revenues from MS drugs and Spinraza [12] Valuation and Estimates - Biogen's stock has declined by 2.2% this year, contrasting with an 8.7% increase in the industry [13] - The company's shares are trading at a forward price/earnings ratio of 9.49, lower than the industry average of 15.88 and its own 5-year mean of 13.55 [15] - The Zacks Consensus Estimate for 2025 earnings has increased from $14.87 to $15.68 per share over the past 90 days [16]

Core Insights - Merck is set to present new research at the ESMO Congress 2025, showcasing over 100 abstracts across more than 20 cancer types, highlighting its commitment to advancing cancer treatment outcomes [1][2]. Group 1: Existing Medicines - Key data on existing medicines in Merck's portfolio will be presented, including findings for KEYTRUDA, LENVIMA, WELIREG, and KEYTRUDA QLEX [2][3]. - Research on KEYTRUDA's impact in bladder, ovarian, and lung cancers will be featured in three Presidential Symposium presentations [2]. Group 2: Investigational Candidates - New data for investigational antibody-drug conjugates (ADCs) will be presented, including raludotatug deruxtecan and ifinatamab deruxtecan, both discovered by Daiichi Sankyo [4]. - Research on sacituzumab tirumotecan, a TROP2-directed ADC, will be shared in four presentations focusing on lung, breast, cervical, and prostate cancers [4]. Group 3: Key Studies - First-time data from the Phase 3 KEYNOTE-905/EV-303 study evaluating KEYTRUDA plus Padcev for muscle-invasive bladder cancer will be presented [6]. - Five-year exploratory follow-up data from the Phase 3 KEYNOTE-775/Study 309 trial evaluating KEYTRUDA plus LENVIMA for advanced endometrial cancer will be showcased [6]. - Ten-year follow-up data from trials evaluating KEYTRUDA monotherapy for metastatic non-small cell lung cancer (NSCLC) will be presented [6]. Group 4: Clinical Research Program - Merck has the largest immuno-oncology clinical research program in the industry, with over 1,600 trials studying KEYTRUDA across various cancers and treatment settings [8].

Core Insights - Bristol Myers (BMY) is focusing on expanding its pipeline due to the negative impact of generics on its legacy portfolio, particularly Revlimid, Pomalyst, Sprycel, and Abraxane [1] - The FDA has granted Fast Track Designation to BMS-986446, an anti-MTBR-tau antibody in phase II development for early Alzheimer's disease [1][10] - BMY's neuroscience portfolio has been enhanced by the FDA approval of xanomeline and trospium chloride (Cobenfy) for schizophrenia, with initial sales of $62 million in the first half of 2025 [2][3] Neuroscience Pipeline - Cobenfy is undergoing registrational trials for Alzheimer's disease, including studies on psychosis, agitation, and cognitive impairment, and is also in a phase III study for bipolar 1 disorder [4] - The drug is expected to be a significant growth driver for BMY as it seeks label expansions into new indications [4] - BMY's neuroscience pipeline includes candidates for neurodegenerative diseases (BMS-986495) and treatments for multiple sclerosis, mood, and anxiety disorders [5] Competitive Landscape - BMY's Alzheimer's candidates will face competition from existing products like Eli Lilly's Kisunla and Biogen and Eisai's Leqembi upon potential approval [6] - Eli Lilly's Kisunla was approved for early symptomatic Alzheimer's disease, and ongoing trials are evaluating its efficacy in preclinical stages [7][8] Financial Performance - BMY's shares have declined by 17.1% year-to-date, contrasting with the industry's growth of 10.4% [9] - The company is trading at a price/earnings ratio of 7.24X forward earnings, below its historical mean of 8.45X and the large-cap pharma industry's average of 15.87X [11] - The bottom-line estimate for 2025 has increased to $6.51 from $6.46, while the estimate for 2026 has decreased to $6.06 from $6.07 [13]

Core Insights - BioArctic AB's partner Eisai has launched lecanemab-irmb (Leqembi Iqlik) as a subcutaneous injection for maintenance treatment of Alzheimer's disease in the U.S. after an initial 18-month intravenous treatment [1][7] - Leqembi is the first anti-amyloid treatment that allows at-home injections, enhancing patient convenience and potentially reducing healthcare resource utilization [3][7] - The Leqembi Companion program has been introduced to support patients throughout their treatment journey, providing resources for insurance, financial support, and injection education [1][2] Company Overview - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, including Alzheimer's disease [10] - The company has a long-standing collaboration with Eisai, which is responsible for the clinical development and commercialization of Leqembi globally [4][9] - BioArctic retains commercialization rights for Leqembi in the Nordic region and has no development costs associated with the drug [9] Product Details - Lecanemab targets both amyloid plaque and protofibrils, which are implicated in the neurodegeneration process of Alzheimer's disease [2][6] - The treatment is approved in 50 countries, including the U.S., Japan, China, and the EU, with ongoing regulatory reviews in 8 additional countries [7] - The Leqembi Iqlik device allows patients to self-administer the treatment at home, which may streamline the overall treatment pathway for Alzheimer's disease [3][7] Clinical Studies - Eisai's Phase 3 clinical study (AHEAD 3-45) is ongoing, focusing on individuals with preclinical Alzheimer's disease, and aims to further evaluate the efficacy of lecanemab [8] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) is also ongoing, incorporating lecanemab as a key treatment component [8]

Group 1 - The AHEAD 3-45 Phase 3 clinical study for individuals with preclinical Alzheimer's disease (AD) has been ongoing since July 2020, focusing on those with elevated amyloid levels in their brains [1] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) began in January 2022, utilizing lecanemab as the primary anti-amyloid therapy [1] - LEQEMBI received approvals in various countries based on Phase 3 data from the Clarity AD clinical trial, achieving its primary endpoint and all key secondary endpoints with statistically significant results [2] Group 2 - The U.S. FDA approved Eisai's Biologics License Application for subcutaneous maintenance dosing with LEQEMBI in August 2025, with a rolling sBLA application for subcutaneous initiation dosing initiated in September 2025 [2]

Core Insights - Eli Lilly and Company (LLY) received marketing authorization from the European Commission for Kisunla (donanemab) to treat early symptomatic Alzheimer's disease (AD) [1][7] - Kisunla is approved for adults with mild cognitive impairment (MCI) and mild dementia stage of AD with confirmed amyloid pathology [1][9] - The approval is supported by data from two late-stage studies, TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6, demonstrating significant slowing of cognitive and functional decline [2][9] Company Performance - Year to date, Eli Lilly's shares have declined by 7.4%, while the industry has seen a decrease of only 0.5% [4] Market Context - Kisunla is part of a competitive landscape in the AD treatment space, alongside Biogen/Eisai's Leqembi, which also targets early symptomatic AD [8][9] - Both drugs aim to reduce amyloid beta (Aβ) plaque accumulation, a key factor in cognitive decline associated with AD [9][10] - Kisunla has shown rapid uptake, recording sales of $70.1 million in the first half of 2025 [10]