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Can BMYs Neuroscience Portfolio Help to Diversify Its Business?
ZACKS· 2025-10-08 16:01
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]
Leqembi® Iqlik™ (lecanemab-irmb) maintenance treatment launched in the U.S.
Prnewswire· 2025-10-06 22:02
Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are prepa ...
BIIB Stock: Is Biogen Still A Buy After The 14% Spike?
Forbes· 2025-10-03 12:50
CANADA - 2025/05/17: In this photo illustration, the Biogen logo is seen displayed on a smartphone screen. (Photo Illustration by Thomas Fuller/SOPA Images/LightRocket via Getty Images)SOPA Images/LightRocket via Getty ImagesBiogen (BIIB) shares recorded their fifth consecutive day of increases, accumulating a total return of 14% during this span. The company’s market value has increased by approximately $3.3 billion over the past 5 days, bringing its current market capitalization to around $23 billion. The ...
LLY Gets EU Approval for Alzheimer's Drug & FDA Nod to Cancer Therapy
ZACKS· 2025-09-26 15:35
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]
Biogen Gets EU Nod for First Postpartum Depression Drug
ZACKS· 2025-09-18 14:21
Core Insights - Biogen's Zurzuvae (zuranolone) has received approval from the European Commission for the treatment of postpartum depression (PPD) in adults, making it the first and only approved treatment for this indication in the European Union [1][7] - The approval is based on the successful phase III SKYLARK study, which demonstrated rapid and sustained relief from depressive symptoms [2][7] - Biogen's stock has underperformed this year, with a 5% decline compared to a 3% growth in the industry [3] Product Performance - Zurzuvae was launched in the United States in December 2023, and sales reached $46.4 million in Q2 2025, reflecting a 68% increase sequentially due to rising demand [6][7] - The drug's launch exceeded Biogen's internal expectations, indicating strong market acceptance [6][7] Strategic Partnerships - Zurzuvae was developed in collaboration with Sage Therapeutics, which has been acquired by Supernus Pharmaceuticals. Biogen and Supernus share profits and losses from the commercialization of Zurzuvae in the U.S. [5] Future Growth Potential - Zurzuvae is one of four new product launches by Biogen, alongside Leqembi for Alzheimer's disease, Skyclarys for Friedreich's Ataxia, and Qalsody for ALS, which are expected to drive long-term growth [8]
奥特曼“续命”大计:押注让大脑变年轻的药物,预计年底临床试验
量子位· 2025-09-16 04:05
Core Viewpoint - The article discusses Sam Altman's increased investment in the biotech startup Retro Biosciences, which aims to extend human lifespan by 10 years through innovative therapies targeting aging and related diseases [3][4][33]. Investment and Company Overview - Sam Altman has invested a total of $180 million (approximately 1.3 billion RMB) in Retro Biosciences, indicating strong support for the company's mission [4]. - Retro Biosciences plans to initiate its first human clinical trial for an experimental drug, RTR242, by the end of 2025 [8][12]. - The company has previously collaborated with OpenAI to develop a model called GPT-4b-micro, designed for protein engineering [5][28]. Scientific Approach and Mechanism - RTR242 aims to enhance the cellular "garbage disposal and recycling system" to clear damaged cellular components, potentially reversing aging effects [16]. - The drug targets "cellular garbage" associated with Alzheimer's and Parkinson's diseases, aiming to restart the autophagy process in aging individuals [17]. - Retro is also developing therapies for leukemia and central nervous system diseases, indicating a broad approach to longevity [34]. Future Goals and Funding - Retro Biosciences has set an ambitious goal to increase healthy human lifespan by 10 years, focusing on maintaining health and vitality until the end of life [33]. - The company aims to raise $1 billion in its Series A funding round to support its clinical trials and research initiatives [35]. - Comparatively, other longevity companies like Altos Labs have raised over $3 billion, highlighting the competitive landscape in the longevity biotech sector [37]. Leadership and Expertise - The CEO of Retro Biosciences, Bates-Lacroix, has a strong background in protein research and has previously led successful ventures in the tech industry [44]. - The company also features a co-founder, Ding Sheng, known for his expertise in stem cell research, enhancing the company's scientific credibility [41].
Will AbbVie's Neuroscience Portfolio Continue to Aid Top-line Growth?
ZACKS· 2025-09-04 14:21
Core Insights - AbbVie has developed a strong neuroscience franchise, initially driven by blockbuster drugs like Botox Therapeutic and Vraylar, and has expanded its portfolio with new migraine treatments Qulipta and Ubrelvy, as well as Vyalev for Parkinson's disease [1][2]. Financial Performance - The neuroscience segment contributed over 17% to AbbVie's total sales in the first half of 2025, with revenues growing nearly 21% year over year, primarily due to increased sales of Botox Therapeutic and Vraylar, along with rising uptake of Ubrelvy and Qulipta [2][9]. - The strong performance in the neuroscience segment has helped mitigate the decline in Duodopa sales [2][9]. Product Launches and Acquisitions - AbbVie launched Vyalev in the U.S. earlier this year, and while initial sales have been modest, expectations are for its contribution to total revenues to grow over time [3]. - The company is actively investing in new therapies, including a recent agreement to acquire Gilgamesh Pharmaceuticals' lead pipeline drug for approximately $1.2 billion, which targets major depressive disorder (MDD). This follows a $1.4 billion acquisition of Aliada Therapeutics, which added an investigational antibody for Alzheimer's disease (AD) [4][5]. Competitive Landscape - Major competitors in the neuroscience space include Biogen and Johnson & Johnson. Biogen is diversifying its offerings due to declining revenues in its multiple sclerosis franchise and has partnered with Eisai to market an FDA-approved treatment for Alzheimer's disease [6]. - Johnson & Johnson has a strong neuroscience portfolio, including the antidepressant nasal spray Spravato and the antipsychotic Invega Sustenna, and recently acquired Intra-Cellular Therapies to enhance its offerings [7]. Valuation and Market Performance - AbbVie shares have outperformed the industry year to date, trading at a premium with a price/earnings (P/E) ratio of 15.59, compared to the industry average of 14.84 and above its five-year mean of 12.82 [8][11]. - Earnings per share (EPS) estimates for 2025 and 2026 have seen slight increases in the past 30 days [12].
Algernon Pharmaceuticals Announces Name Change to Algernon Health
Globenewswire· 2025-09-04 11:00
Core Viewpoint - Algernon Pharmaceuticals Inc. is rebranding to Algernon Health to focus on the Alzheimer's Disease diagnostic market and establish specialized neuroimaging clinics across North America [1][2] Company Strategy - The new clinics will utilize FDA-cleared, optimized brain-specific Positron Emission Tomography (PET) scanning systems to detect amyloid plaques, offering significantly lower radiation than standard PET/CT machines [2][5] - The PET scans will be covered by Medicare, Medicaid, and private insurance in the U.S., providing a clear revenue pathway for the company [5][11] Market Opportunity - There is a growing demand for Alzheimer's diagnostics, with 162 AD drugs currently under development, creating additional revenue opportunities for Algernon through imaging services for drug development companies and clinical trials [7][6] - The majority of existing PET/CT scanners in the U.S. are dedicated to cancer and cardiac imaging, leading to a shortage for brain-specific scanning, which Algernon aims to address [6][5] Future Plans - Algernon will soon announce its expansion and growth plans, including the location of its first U.S. flagship neuroimaging clinic [8] - The company continues to advance its subsidiary, Algernon NeuroScience, which is investigating a proprietary form of DMT for stroke and traumatic brain injury [9][11]
Rolling sBLA initiated to the U.S. FDA for Leqembi® Iqlik™ (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer's disease under Fast Track status
Prnewswire· 2025-09-03 03:01
Core Insights - BioArctic AB's partner Eisai has initiated a rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. FDA for Leqembi Iqlik (lecanemab-irmb) as a subcutaneous autoinjector, following the FDA granting Fast Track Status [1][15] - Leqembi Iqlik, if approved, would be the first anti-amyloid treatment allowing at-home injection from the start, enhancing treatment accessibility for Alzheimer's disease patients [1][2] Company Overview - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, having developed Leqembi, the first drug proven to slow Alzheimer's disease progression [11] - The collaboration between BioArctic and Eisai dates back to 2005, with Eisai responsible for clinical development and commercialization, while BioArctic retains rights for commercialization in the Nordic region [4][10] Product Details - Leqembi is indicated for treating Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia, and is currently approved in 48 countries, with regulatory reviews ongoing in 10 countries [2][7] - The sBLA submission is based on Phase 3 clinical studies evaluating subcutaneous administration of lecanemab, which could offer a weekly starting dose as an alternative to bi-weekly intravenous dosing [2][3] Clinical Development - Eisai's ongoing Phase 3 clinical study (AHEAD 3-45) involves individuals with preclinical Alzheimer's disease and aims to assess the efficacy of lecanemab [9] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) is also ongoing, incorporating lecanemab as a key anti-amyloid therapy [9] Treatment Mechanism - Leqembi targets both amyloid plaque and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's disease [3][14] - The subcutaneous formulation of Leqembi has the potential to reduce healthcare resource utilization associated with intravenous dosing, streamlining the treatment pathway for Alzheimer's disease [2]
Eli Lilly's New Drugs Beyond Mounjaro and Zepbound Boost Sales
ZACKS· 2025-09-02 15:06
Core Insights - Eli Lilly and Company (LLY) has significantly increased its market value over the past 2-3 years, primarily due to the success of its GLP-1 drugs, Mounjaro for type II diabetes and Zepbound for obesity [1] Drug Approvals and Revenue Contributions - Lilly has received approvals for several new drugs, including Omvoh for ulcerative colitis and Crohn's disease, Jaypirca for mantle cell lymphoma and chronic lymphocytic leukemia, Ebglyss for atopic dermatitis, and Kisunla for early symptomatic Alzheimer's disease, all contributing to revenue growth [2] - In the first half of 2025, Omvoh generated $111.9 million, while Ebglyss, Kisunla, and Jaypirca contributed $147.1 million, $70.1 million, and $215.3 million, respectively [3] Future Growth Potential - These drugs are being evaluated for additional indications and label expansions, with Ebglyss in phase III trials for perennial allergens and chronic rhinosinusitis, and Jaypirca being studied for earlier lines of therapy [4] - Lilly anticipates that Omvoh, Ebglyss, Kisunla, and Jaypirca will continue to drive revenue growth in the second half of 2025 [5] Upcoming Drug Approvals - A new drug, imlunestrant, is under review for treating ER+HER2-metastatic breast cancer in the US and EU [6] Competitive Landscape - Omvoh faces competition from AbbVie's Humira, Skyrizi, and Rinvoq, as well as J&J's Stelara, while Kisunla competes with Eisai/Biogen's Leqembi [7][8] - Jaypirca competes with older BTK inhibitors like Imbruvica and Calquence, and Ebglyss faces competition from Dupixent [9] Stock Performance and Valuation - Lilly's stock has declined by 4.6% this year, contrasting with a 1.3% increase in the industry [10] - The combined revenue from Omvoh, Ebglyss, Kisunla, and Jaypirca exceeded $540 million in H1 2025, with EPS estimates for 2025 and 2026 rising to $22.97 and $30.95, respectively [11] - Lilly's stock is currently trading at a price/earnings ratio of 25.87, higher than the industry average of 14.78, but below its 5-year mean of 34.54 [13] Consensus Estimates - The Zacks Consensus Estimate for 2025 EPS has increased from $22.04 to $22.97 over the past 30 days, while the estimate for 2026 has risen from $30.88 to $30.95 [14]