格隆汇10月1日｜美股医药股逆势上涨，阿斯利康涨超6%，赛诺菲安万特、葛兰素史克涨近4%，礼 来、渤健公司、诺和诺德、默沙东涨近3%，辉瑞涨超2%。 ...

Core Insights - Eisai Co., Ltd. and Biogen Inc. announced the approval of LEQEMBI (lecanemab) for intravenous maintenance dosing every four weeks in China, following its initial approval for treating early Alzheimer's disease in January 2024 [1][2] Group 1: Product Information - LEQEMBI is a humanized monoclonal antibody targeting both soluble and insoluble forms of amyloid-beta, addressing the neurodegenerative processes associated with Alzheimer's disease [3][7] - The drug has been approved in 50 countries and is under regulatory review in 10 additional countries, with a maintenance dosing regimen of 10 mg/kg every four weeks approved in China and the U.S. [7][8] - The primary endpoint for LEQEMBI's approval was the Clinical Dementia Rating Sum of Boxes (CDR-SB), with significant results from the global Clarity AD clinical trial [8] Group 2: Market Potential - As of 2024, there are an estimated 17 million patients in China with mild cognitive impairment or mild dementia due to Alzheimer's disease, a number expected to rise with the aging population [4] - The collaboration between Eisai and Biogen for the development and commercialization of Alzheimer's treatments has been ongoing since 2014, with Eisai leading regulatory submissions globally [10] Group 3: Research and Development - Ongoing clinical studies include the AHEAD 3-45 trial for individuals with preclinical Alzheimer's disease and the Tau NexGen study for Dominantly Inherited Alzheimer's Disease, both involving lecanemab [9]

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].

Group 1 - Biogen Inc. is considered one of the most undervalued stocks on NASDAQ, with a recent acquisition of Alcyone Therapeutics for an initial cash payment of $85 million and additional milestone payments [1] - The acquisition centers on ThecaFlex DRx, an implantable device aimed at providing chronic medication delivery for patients with neurological illnesses, eliminating the need for repeated lumbar punctures [2] - Following the acquisition, Biogen will oversee the development, production, and marketing of ThecaFlex DRx, with ongoing clinical studies assessing its effectiveness in patients with spinal muscular atrophy using SPINRAZA (nusinersen) [3]

Core Viewpoint - Top Wall Street analysts have revised their outlook on several prominent companies, indicating potential shifts in investment sentiment and opportunities in the market [1]. Company Analysis - Analysts are considering buying FCX stock, suggesting a positive outlook for the company [1].

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our analyst ratings page.Considering buying BIIB stock? Here’s what analysts think: Read This Next: Photo via ShutterstockLoading...Loading... ...

Core Insights - The company is optimistic about the progress of the new Biogen, particularly in the context of the Alzheimer's drug launch, LEQEMBI [1] Group 1: Product Development - The recent approval for subcutaneous maintenance of LEQEMBI is seen as a significant advancement for patient treatment options [1] - The company has initiated a rolling submission for subcutaneous initiation, which is expected to enhance patient accessibility to the treatment [1] - The potential for patients to use an autoinjector at home represents a shift towards more convenient treatment options, while still allowing the choice of infusion center visits [1]

Core Viewpoint - Biogen's supplemental new drug application (sNDA) for a higher dose of Spinraza received a complete response letter (CRL) from the FDA, requesting updates to the Chemistry, Manufacturing, and Controls section without citing clinical data deficiencies [1][8]. Regulatory Developments - The company plans to resubmit the regulatory application quickly based on readily available information [2]. - A similar application for the higher dose of Spinraza is under review in the EU, while the high-dose regimen has already been approved in Japan [6][5]. Dosing Regimen - The new higher dosing regimen includes two initial 50 mg doses at a 14-day interval, followed by a 28 mg maintenance dose every four months, compared to the current regimen of four loading doses of 12 mg [3][4]. - This new regimen is expected to reduce dosing frequency and provide significant clinical benefits for SMA patients [4]. Clinical Data and Benefits - The regulatory filings are supported by data from the phase II/III DEVOTE study, which showed statistically significant improvement in motor function in infants treated with the higher dose [4]. - Management believes that the higher dose could slow neurodegeneration more effectively, with greater reductions in neurofilament observed as early as day 64 [5]. Competitive Landscape - Spinraza faces competition from Novartis' Zolgensma and Roche/PTC Therapeutics' Evrysdi, both approved for SMA, which has negatively impacted Spinraza's sales [10][11]. - Sales of Spinraza declined by 8.5% in Q2 2025 due to increased competitive pressure, and global revenues are expected to remain flat in 2025 [11]. Stock Performance - Biogen's shares have decreased by 8.9% this year, contrasting with a 4.3% increase in the industry [7].

Biogen FY Conference Summary Company Overview - **Company**: Biogen (NasdaqGS:BIIB) - **Date of Conference**: September 24, 2025 Key Points Alzheimer's Disease and LEQEMBI - Biogen is experiencing positive momentum with the launch of LEQEMBI, particularly following the approval for subcutaneous maintenance therapy, which offers patients the option to self-administer at home [2][10] - The company is also pursuing a rolling submission for subcutaneous initiation therapy, expected to provide patients with more treatment options [2][10] - The approval of blood-based biomarkers by the FDA is seen as a significant advancement, increasing testing and potentially improving patient outcomes [3] Revenue Growth and R&D Focus - Year-on-year revenue growth from new products is offsetting declines from multiple sclerosis (MS) products, indicating a strategic shift towards growth products [4] - Biogen is focusing on high-value, high-probability success programs in its R&D pipeline, with several late-stage programs expected to yield registrational data soon [4][5] Pipeline Developments - Biogen is advancing several programs into Phase 3 trials, including treatments for lupus and rare nephrology conditions [5][6] - The company is also exploring new modalities and collaborations, such as with Stoke Therapeutics for Dravet syndrome [6][7] TAU ASO and CELIA Study - The TAU ASO (BIIB080) is in Phase 2 trials, with hopes to demonstrate significant reductions in TAU levels and clinical benefits [11][12] - The CELIA study aims to evaluate the impact of reducing all TAU isoforms on biomarkers and clinical outcomes [12] GLP-1 and Alzheimer's - Biogen acknowledges the potential of GLP-1 therapies in addressing neuroinflammatory pathways in Alzheimer's, despite mixed results from other trials [15] AHEAD Trials - The AHEAD 3 and AHEAD 4, 5 trials are designed to address pre-symptomatic stages of Alzheimer's, focusing on preventing further amyloid accumulation and cognitive decline [17][18] SMA and SPINRAZA - Biogen continues to focus on spinal muscular atrophy (SMA) with SPINRAZA, which remains a critical therapy despite competition from gene therapies [22][23] - The company is pursuing a high-dose version of SPINRAZA and a new antisense oligonucleotide, Salinursin, with promising early data [24][25] Lupus Opportunities - Lupus is identified as a significant market opportunity, with only two biologics currently available and a high unmet need [27][28] - Biogen is advancing Dapirolizumab pegol and litifilimab through multiple Phase 3 trials, targeting different lupus manifestations [29][30] Felsardimab and Rare Kidney Indications - Felsardimab is being explored for several rare kidney conditions, with ongoing Phase 3 trials and a focus on addressing unmet needs in these areas [39][40] - The company is optimistic about the potential of Felsardimab in conditions like AMR and IgAN, despite a crowded competitive landscape [41][42] IRAK4 Program - The IRAK4 program is in early development stages, with plans for a Phase 2 program to explore its potential in various inflammatory conditions [48] Overall R&D Strategy - Biogen's R&D strategy emphasizes a diversified pipeline with multiple high-value programs, aiming for significant market impact across various therapeutic areas [50] - The company is committed to innovation and disciplined cost management while expanding its portfolio through both internal and external collaborations [50] Conclusion - Biogen is positioned for growth with a robust pipeline across neurology, immunology, and rare diseases, focusing on high unmet needs and innovative therapies [50]

Core Viewpoint - Eisai Co., Ltd. and Biogen Inc. announced the approval of LEQEMBI (lecanemab) by the Therapeutic Goods Administration (TGA) of Australia for treating mild cognitive impairment or mild dementia due to Alzheimer's disease in specific adult populations [1][2]. Group 1: Product Approval and Clinical Data - The approval of LEQEMBI was based on Phase 3 data from the Clarity AD clinical trial, which demonstrated a 33% reduction in clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale at 18 months compared to placebo [9]. - The Clarity AD trial involved 1,795 patients with early Alzheimer's disease, with 1,521 patients in the Australian indicated population [9]. - LEQEMBI has been approved in 50 countries and is under regulatory review in 8 countries, with significant results from the global Clarity AD clinical trial [8]. Group 2: Alzheimer's Disease Context - In Australia, the number of people living with dementia is estimated to rise from approximately 425,000 in 2024 to nearly 1,100,000 by 2065, with Alzheimer's disease accounting for 60-70% of dementia cases [3]. - Alzheimer's disease is characterized by a progressive neurotoxic process involving amyloid beta (Aβ) and tau, with LEQEMBI targeting both toxic protofibrils and amyloid plaques [3][8]. Group 3: Collaboration and Development - Eisai leads the global development and regulatory submissions for lecanemab, with Biogen co-commercializing and co-promoting the product [4][12]. - Eisai and BioArctic have collaborated since 2005 on the development and commercialization of Alzheimer's disease treatments, with Eisai obtaining global rights for lecanemab in 2007 [13].