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Lantheus to Present Florbetaben F 18 Data at CTAD 2025
Globenewswire· 2025-11-24 13:30
BEDFORD, Mass., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced the presentation of new florbetaben F18 data at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) 2025 conference, taking place December 1-4, in San Diego, CA. Presentation details are as follows: Poster Presentation Date & Time: Wednesda ...
The Privilege of Grief | Dhaya Sudhakar | TEDxYouth@PMSS
TEDx Talks· 2025-11-11 17:11
At like many other people at our school, I volunteer at Eagle Ridge Hospital. I'm in the PATH dining assistance program where my job is to mainly listen to the patients and hear what they have to say and just engage in conversation with them. I'm assigned to E2B and for those who are the same, you know, it's really not sunshine and rainbows in that ward.It usually hosts older patients. Some who stay for a couple of days, some who stay for a couple of weeks, and some who stay much longer. However, regardless ...
A Brain You Save Should Be Your Own: Why Cognitive Decline is Optional | Kristine Burke | TEDxFolsom
TEDx Talks· 2025-11-10 16:22
Raise your hand if you've ever walked into a room and forgotten why you went there. Now, keep it up just a little if you've ever panicked just for a moment, wondering whether this is how it all starts, whether this is the beginning of losing your mind. I'm Dr. . Dr.. Christine Burke, a triple board certified physician and clinical researcher, and my team and I have spent the better half of the last decade helping people with one of the most terrifying prospects we face as we age, losing our cognitive abilit ...
X @Bloomberg
Bloomberg· 2025-11-08 13:15
Health & Longevity - Women generally live longer than men globally [1] - Women are more susceptible to debilitating conditions like Alzheimer's disease [1] Research Focus - Understanding the reasons behind these differences could lead to improved aging for both sexes [1]
Wall Street Breakfast Podcast: Papa John's Delivers A Hot Slice
Seeking Alpha· 2025-10-14 11:49
Group 1: Papa John's Takeover Bid - Papa John's shares rose nearly 10% after a report of a $64 per share takeover bid from Apollo Global, valuing the company at approximately $2 billion [1][2] - The stock continued to show positive movement, increasing by 3% in premarket trading [2] Group 2: Alzheimer's Diagnostic Test Approval - The U.S. FDA approved Elecsys pTau181, a blood-based biomarker test developed by Roche and Eli Lilly for initial assessment of Alzheimer's disease and cognitive decline [3][4] - This test measures phosphorylated Tau (pTau) 181 protein in human plasma, serving as a key biomarker for Alzheimer's pathology [3][4] - Elecsys pTau181 is noted to potentially reduce the need for more invasive and costly diagnostic procedures like PET and CSF testing [5] Group 3: PayPay's IPO Valuation - PayPay, Japan's leading QR code payment app, is expected to have a valuation exceeding $20 billion in its planned U.S. IPO, potentially occurring as early as December 2025 [5][6] - Investor discussions suggest a floor valuation of 2 trillion yen, with market sources indicating the final figure could surpass 3 trillion yen [6][7] - The optimism surrounding PayPay's valuation is attributed to its dominant position in Japan's digital payments market and recent profitability in SoftBank's financial segment [7]
Alpha Cognition (NasdaqCM:ACOG) Conference Transcript
2025-10-08 13:32
Summary of Alpha Cognition Conference Call - October 08, 2025 Company Overview - **Company**: Alpha Cognition (NasdaqCM: ACOG) - **Lead Product**: Zunvil, approved by the FDA for mild to moderate Alzheimer's disease in Q3 2024 [2][3] Industry Context - **Target Market**: Long-term care facilities, specifically nursing homes, which represent a $2 billion opportunity for Zunvil [13][14] - **Alzheimer's Disease**: Affects memory, cognitive function, and behavior; approximately 40% of Alzheimer's patients spend their lifespan in assisted living or long-term care [4][14] Core Product Insights - **Zunvil Characteristics**: - A prodrug of galantamine, designed to minimize gastrointestinal side effects [5][6] - Demonstrates improved tolerability with less than 2% of patients reporting GI issues [11] - 0% incidence of insomnia compared to 30% for leading competitors [12] - Proven cognitive effects and functional performance, targeting behavioral symptoms common in Alzheimer's patients [12][13] Commercialization Strategy - **Launch Details**: - Launched in April 2025, generating over 1,500 prescriptions in the first quarter [3][19] - Focused on long-term care market due to high concentration of Alzheimer's patients and fewer payer restrictions [13][14] - **Sales Strategy**: - 50 salespeople targeting nursing homes and medical directors [16] - Engaged with nearly 2,000 nursing homes, with 15% writing prescriptions for Zunvil [17] - Plans for strategic partnerships with pharmacies and long-term care facilities [18] Financial Outlook - **Revenue**: Generated approximately $1.7 million in the first quarter, with expectations for steady growth [19] - **Expense Guidance**: Projected expenses between $34 to $38 million, targeting profitability by 2027 [3][20] - **Market Potential**: If Zunvil captures 10% to 25% of the market, it could generate $200 to $600 million in sales [20][31] Pipeline and Future Developments - **Additional Products**: - A sublingual formulation for patients with swallowing difficulties, expected to enter clinical studies in early 2026 [21] - A product targeting cognitive impairment from concussions, with data expected mid-next year [22] - **Market Expansion**: Plans to enter the neurology segment, representing a $1.5 billion opportunity, post achieving break-even status [25][26] Competitive Landscape - **Market Size**: The acetylcholinesterase inhibitor market is estimated at $6 to $7 billion, with historical products achieving billion-dollar sales [29][30] - **Differentiation**: Zunvil's unique formulation and tolerability profile position it as a disruptive force in the market [33] Key Takeaways - **Management Team**: Experienced team with a strong track record in drug launches [24] - **Future Focus**: Continued education for healthcare providers and strategic partnerships to enhance market penetration [33] This summary encapsulates the key points discussed during the Alpha Cognition conference call, highlighting the company's strategic direction, product differentiation, and market potential.
NewAmsterdam Pharma Provides Corporate Update and Reports Second Quarter Financial Results
Globenewswire· 2025-08-06 11:00
Core Insights - NewAmsterdam Pharma is advancing its oral, low-dose CETP inhibitor obicetrapib, targeting cardiovascular disease and Alzheimer's pathology, with significant clinical data supporting its efficacy [3][4][10] - The company reported a substantial increase in revenue for Q2 2025, recognizing $19.1 million compared to $2.3 million in Q2 2024, primarily due to development cost contributions from Menarini [7][19] - NewAmsterdam's cash position as of June 30, 2025, was $783.3 million, down from $834.2 million at the end of 2024, reflecting ongoing operating expenditures [7][19] Clinical Development Updates - The PREVAIL Phase 3 cardiovascular outcomes trial has completed enrollment of over 9,500 patients, focusing on those with a history of ASCVD [9][10] - Positive topline data from the BROADWAY trial indicated a statistically significant reduction in p-tau217 levels, a key Alzheimer's biomarker, in patients treated with obicetrapib [4][12] - The company plans to launch the Phase 3 RUBENS trial later in 2025, evaluating obicetrapib in combination with ezetimibe for patients with type 2 diabetes and metabolic syndrome [3][4] Financial Performance - NewAmsterdam reported a net loss of $17.4 million for Q2 2025, an improvement from a net loss of $39.0 million in Q2 2024 [7][19] - Research and development expenses decreased to $27.5 million in Q2 2025 from $38.4 million in the same period in 2024, attributed to reduced clinical expenses [7][19] - Selling, general, and administrative expenses rose to $27.3 million in Q2 2025, up from $16.5 million in Q2 2024, driven by increased personnel costs and marketing investments [7][19] Market Context - Cardiovascular disease remains a leading global health issue, with a projected increase in affected U.S. adults to over 184 million by 2050, highlighting the need for effective LDL-C lowering therapies [11] - Despite the availability of lipid-lowering therapies, many patients remain undertreated, with only 10% of very high-risk ASCVD patients achieving LDL-C goals below 55 mg/dL [11] - The company aims to address this unmet need with obicetrapib, which has shown promising LDL-C reduction and a favorable safety profile in clinical trials [10][11]
X @Bloomberg
Bloomberg· 2025-07-28 18:26
Health & Wellness - Simple steps to stay mentally and physically active improved thinking and helped keep Alzheimer's disease at bay for older Americans at high-risk of developing dementia [1] - The positive effects of these steps were observed relatively quickly [1]
INmune Bio to Present Phase 2 MINDFuL Trial Findings of XPro™ at the Alzheimer’s Association International Conference
Globenewswire· 2025-07-24 11:00
Core Insights - INmune Bio Inc. announced additional analyses from its Phase 2 MINDFuL trial for XPro™, a selective soluble TNF inhibitor, to be presented at the Alzheimer's Association International Conference in Toronto on July 29, 2025 [1] - The MINDFuL trial is a double-blind, Phase 2 proof-of-concept study aimed at evaluating XPro™'s potential to slow cognitive decline in early-stage Alzheimer's disease by targeting neuroinflammation [2] - Although the primary endpoint was not met in the overall modified-intent-to-treat group, significant benefits were observed in a subpopulation with confirmed amyloid-beta pathology and systemic inflammation biomarkers [3] Study Details - The MINDFuL trial enrolled 208 participants with early Alzheimer's disease, requiring at least one biomarker of inflammation [2][6] - Participants received XPro™ or placebo in a 2:1 ratio for 24 weeks, with cognitive changes measured using the Early Mild Alzheimer's Cognitive Composite [2][6] - The trial's findings suggest a potential therapeutic approach for Alzheimer's by targeting inflammation [4] Future Plans - INmune Bio plans to submit a publication of the MINDFuL Phase 2 study results by mid-August [4] - The company is seeking strategic partnerships to expedite the development of XPro™ for Alzheimer's treatment [4] Product Information - XPro™ is designed to inhibit soluble TNF while preserving trans-membrane TNF and TNF receptors, potentially enhancing cognitive function and neuronal communication [7] - INmune Bio focuses on developing treatments that target the innate immune system, with XPro™ being part of its Dominant-Negative Tumor Necrosis Factor product platform [8][9]
INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro™ in Early Alzheimer's Disease
Globenewswire· 2025-06-30 11:30
Core Insights - The Phase 2 MINDFuL trial of XPro™ in early Alzheimer's Disease (AD) patients with inflammation biomarkers did not meet the primary cognitive endpoint in the modified intent-to-treat (mITT) population, but showed cognitive, behavioral, and biological benefits in a predefined subgroup of amyloid-positive patients with two or more inflammation biomarkers [1][3][4] Group 1: Trial Results - The MINDFuL trial enrolled 208 participants with early-stage AD, assessing XPro™'s potential to slow cognitive decline by targeting neuroinflammation [4] - In the predefined subgroup of amyloid-positive early AD patients with two or more inflammation biomarkers (n=100), XPro™ demonstrated a cognitive benefit on the primary endpoint EMACC (effect size: 0.27) and a behavioral benefit on the Neuropsychiatric Inventory (effect size: -0.24) [7] - A biological benefit was observed in blood levels of pTau217 (effect size: -0.20), indicating a positive impact on AD pathology [7] Group 2: Safety and Tolerability - XPro™ treatment was well-tolerated and safe, with no occurrences of ARIA-E or ARIA-H reported [2][7] - The most common adverse events were injection site reactions, occurring in 80% of the XPro™ group compared to less than 20% in the placebo group [7] - There were no deaths or drug-related hospitalizations during the trial, indicating a favorable safety profile [7] Group 3: Future Plans - The company plans to submit for Breakthrough Therapy designation with the FDA and will present additional analyses at the Alzheimer's Association International Conference (AAIC) in July 2025 [2][10] - The company aims to engage regulatory authorities in the UK, EU, and other regions to define the path for a pivotal trial to support XPro™ approval in early AD [14]