New LEQEMBI Companion™ program launched to expand helpful resources for patients throughout the treatment journey, including Nurse Educators who can provide patients with injection training, and an injection tracking tool and more LEQEMBI IQLIK, approved by the U.S. FDA in August 2025, is the first and only anti-amyloid treatment to offer an at-home injection after initial treatment of 18 months TOKYO and CAMBRIDGE, Mass., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo N ...

Core Thesis - Biogen Inc. is viewed as undervalued with a strong potential for growth driven by its Alzheimer's drug lecanemab and a solid multiple sclerosis franchise [2][4]. Financial Performance - As of September 18th, Biogen's share price was $143.81, with trailing and forward P/E ratios of 13.86 and 9.04 respectively [1]. - The consensus for Q2 revenue is $2.65 billion, reflecting a 3% year-over-year decline, with expected EPS of $3.20 [2]. - Recent real-world data indicated a 25% reduction in hospitalizations, which may lead to an FDA label expansion and increased drug uptake [2]. Pipeline and R&D - Biogen's pipeline includes therapies for spinal muscular atrophy (SMA) and synuclein-targeting Parkinson's, providing multiple opportunities through 2027 [3]. - The company has a strong balance sheet with $10 billion in cash and $6 billion in debt, allowing for significant R&D investment, buybacks, or M&A activities [3]. Technical Analysis - The stock has shown resilience, bouncing off a support level of $125 and currently trading just below the 100-day SMA of $129 [3]. - Resistance levels are identified between $132 and $136, with the stock positioned for a potential post-earnings movement [3]. Investment Scenarios - Potential upside for the stock is projected between $138 and $145 if earnings exceed expectations, while downside risk is noted between $118 and $122 if multiple sclerosis sales underperform [4]. - A suggested entry point for investors is around $128 to $130, with strategies to scale into strength above $132 or to add on pullbacks [4].

Core Viewpoint - NKGen Biotech has initiated the administration of troculeucel, an autologous NK cell therapy, to a patient with mild-stage Alzheimer's disease under a compassionate use IND authorization from the FDA, marking a significant step in expanding treatment options for patients who do not respond to existing therapies [1][2]. Company Overview - NKGen Biotech is a clinical-stage biotechnology company focused on developing and commercializing innovative autologous and allogeneic NK cell therapeutics, headquartered in Santa Ana, California [4]. - Troculeucel, the company's novel cell-based immunotherapeutic drug candidate, is being developed for neurodegenerative disorders and various cancers, with its International Nonproprietary Name (INN) approved by the WHO [5]. Clinical Development - The ongoing double-blind randomized Phase 2a trial by NKGen is primarily focused on moderate-stage Alzheimer's disease, while the recent IND authorization allows exploration in mild-stage Alzheimer's, particularly for patients unresponsive to first-line therapies [2]. - Clinical experience with troculeucel indicates it is well-tolerated and capable of crossing the blood-brain barrier, improving levels of amyloid, α-synuclein, and tau proteins in cerebrospinal fluid, and reducing neuroinflammation [3]. Industry Context - Currently, there are two FDA-approved amyloid-targeting therapies for Alzheimer's patients with mild cognitive impairment, which slow cognitive decline but do not halt disease progression or improve cognitive function [3]. - The exploration of troculeucel in patients progressing on standard therapies could provide insights into disease mechanisms and support combination treatment strategies [3].

Core Points - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion for the anti-Aβ monoclonal antibody lecanemab, which was initially adopted in November 2024, allowing the European Commission (EC) to resume its decision-making process for marketing authorization [1][2] - Lecanemab is currently under regulatory review in 18 countries and regions, with approvals already granted in multiple countries including the U.S., Japan, and China [7] - The approval of lecanemab would address the significant unmet need for new treatment options for Alzheimer's disease, which currently affects an estimated 15.2 million people with mild cognitive impairment and 6.9 million with Alzheimer's dementia in Europe [3] Company Collaboration - Eisai serves as the lead for lecanemab's development and regulatory submissions globally, with Biogen co-commercializing and co-promoting the product [5][9] - The collaboration between Eisai and Biogen for Alzheimer's disease treatments has been ongoing since 2014, with Eisai holding final decision-making authority [9] - Eisai has a long-term collaboration with BioArctic for the development and commercialization of Alzheimer's treatments, having obtained global rights for lecanemab in December 2007 [10][11] Clinical Studies - The Phase 3 clinical study AHEAD 3-45 for individuals with preclinical Alzheimer's disease is ongoing, funded by the National Institute on Aging, Eisai, and Biogen [8] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) is also ongoing and includes lecanemab as the backbone anti-amyloid therapy [8]