Neurodegenerative diseases
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Hangzhou Highlightll Pharmaceutical Co., Ltd. - B(H0196) - Application Proof (1st submission)
2025-12-03 16:00
Hangzhou Highlightll Pharmaceutical Co., Ltd. 杭州高光製藥股份有限公司 (A joint stock company established in the People's Republic of China with limited liability) WARNING The publication of this Application Proof is required by The Stock Exchange of Hong Kong Limited (the "Stock Exchange") and the Securities and Futures Commission (the "Commission") solely for the purpose of providing information to the public in Hong Kong. This Application Proof is in draft form. The information contained in it is incomplete and is s ...
Annovis To Present at the 2025 Annual Meeting of the Parkinson Study Group
Globenewswire· 2025-12-03 13:00
Core Insights - Annovis Bio, Inc. is set to present at the 2025 Annual Meeting of the Parkinson Study Group, showcasing its advancements in therapies for neurodegenerative diseases like Alzheimer's and Parkinson's [1][5] Group 1: Presentation Highlights - The presentation will build on recent Phase 3 PD biomarker data, indicating that patients with amyloid co-pathology show significant cognitive decline, which is counteracted and reversed by the drug buntanetap [2] - A cross-study comparison of completed trials will be introduced, providing a comprehensive overview of cognitive outcomes across all tested indications, particularly highlighting the benefits for patients with amyloid pathology [3] - Findings suggest that individuals with biomarker-confirmed amyloid presence experience the greatest cognitive gains following treatment with buntanetap, validating the drug's mechanism as a translational inhibitor of neurotoxic aggregating proteins [3] Group 2: Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania, and focuses on developing innovative therapies aimed at improving outcomes and quality of life for patients suffering from neurodegenerative diseases [6] - The company is committed to advancing research and showcasing best practices in the field of Parkinson's disease [5]
Annovis Announces Novel Biomarker Data in Alzheimer's Patients Supporting Buntanetap's Potential as a Disease-Modifying Treatment
Globenewswire· 2025-10-09 11:30
Core Insights - Annovis Bio, Inc. announced new results indicating that its drug candidate, buntanetap, can reduce inflammation and improve cellular health in Alzheimer's patients, suggesting potential disease-modifying effects beyond just symptomatic relief [1][2]. Group 1: Clinical Study Results - The Phase 2/3 study analysis showed that buntanetap effectively targets key biomarkers of neuroinflammation and neurodegeneration, leading to reductions in inflammatory markers such as IL-5, IL-6, S100A12, IFN-γ, and IGF1R compared to placebo [2]. - Buntanetap also decreased levels of neurofilament light chain (NFL), a marker of neuronal damage, indicating improved cellular integrity and neuronal health, particularly in patients with positive pTau217 plasma levels [2][3]. Group 2: Mechanism and Therapeutic Potential - The drug's ability to target multiple neurotoxic proteins simultaneously is highlighted as a significant advantage, potentially interrupting the toxic cascade associated with Alzheimer's disease [3]. - Previous clinical benefits were noted in mild Alzheimer's patients, who experienced significant cognitive improvements, reinforcing the potential of buntanetap as a disease-modifying therapy [3]. Group 3: Ongoing Research and Future Outlook - Buntanetap is currently undergoing a pivotal Phase 3 trial in early Alzheimer's disease, with a 6-month readout focused on symptomatic improvement and an 18-month readout aimed at assessing disease modification [3][4]. - The full biomarker data will be presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference in December 2025, which is expected to provide further insights into the drug's efficacy [4].
Alector (NasdaqGS:ALEC) Update / Briefing Transcript
2025-09-22 17:02
Summary of Elektor's Conference Call Company Overview - **Company**: Elektor - **Focus**: Development of disease-modifying therapies for neurodegenerative diseases, including Alzheimer's and frontotemporal dementia (FTD) [6][7] Key Industry Insights - **Neurodegenerative Diseases**: Elektor is addressing urgent unmet needs in neurodegenerative diseases through an integrated biotech approach combining genetics, immunology, and neuroscience [6] - **Progranulin Elevating Franchise**: The company is developing therapies targeting progranulin levels to treat FTD caused by granulin mutations and Alzheimer's disease [9][10] Core Points and Arguments - **Pipeline Overview**: Elektor has a multistage pipeline with late-stage programs, including: - **Latazimumab**: For FTD GRN, received breakthrough therapy and orphan drug designations, with phase three data expected by mid-Q4 2025 [7][22] - **Nivisibart (formerly AL101)**: For Alzheimer's disease, fully enrolled in a phase two trial [8][25] - **ABC Technology**: The proprietary electro brain carrier (ABC) technology enhances drug delivery across the blood-brain barrier, improving therapeutic efficacy [7][27] - **Clinical Data**: In the INFRANT2 phase two study, Latazimumab demonstrated a 48% slowing of clinical progression in symptomatic FTD GRN patients compared to matched historical controls [22] - **Economic Burden**: The economic burden per patient for FTD is nearly double that of Alzheimer's, highlighting the urgency for effective therapies [11] Additional Important Content - **Genetic Testing**: Increased uptake of genetic testing is anticipated as disease-specific treatments become available, which could shift the diagnostic landscape for FTD GRN [12] - **Partnership with GSK**: The collaboration includes significant financial commitments, with $700 million in upfront payments and potential milestones totaling $1.5 billion [26] - **Future Programs**: Elektor is developing additional therapies, including: - **Anti-amyloid beta antibodies**: Targeting Alzheimer's disease with two candidates, AL037 and AL137, showing promising preclinical results [46][45] - **Enzyme replacement therapy for Parkinson's disease**: Targeting GBA mutations with engineered GK's enzyme [47][50] - **siRNA programs**: Targeting tau, alpha-synuclein, and NLRP for various neurodegenerative diseases [76][77] Financial Position - **Cash Resources**: Elektor has over $300 million in demand to support ongoing and future programs [82] Conclusion - Elektor is positioned to make significant advancements in the treatment of neurodegenerative diseases through its innovative therapies and technologies, with multiple catalysts expected in the near future [82]
Annovis to Present at the H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-09-02 12:00
Core Insights - Annovis Bio, Inc. is a late-stage clinical drug platform company focused on developing transformative therapies for neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease [1][4] Group 1: Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania and is dedicated to addressing neurodegeneration in diseases like Alzheimer's and Parkinson's [4] - The company aims to develop innovative therapies that improve patient outcomes and quality of life [4] Group 2: Upcoming Events - CEO Maria Maccecchini, Ph.D., will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, at the Lotte New York Palace Hotel [1] - Interested parties can schedule one-on-one meetings with Dr. Maccecchini through the conference portal [3]
ProMIS Neurosciences Announces Second Quarter 2025 Financial Results & Corporate Highlights
GlobeNewswire News Room· 2025-08-13 11:00
Core Insights - ProMIS Neurosciences has received Fast Track designation from the U.S. FDA for its Alzheimer's disease treatment candidate PMN310, enhancing its potential for priority review [2][11] - The PRECISE-AD Phase 1b trial for PMN310 is progressing well, with over 50% of the planned 128 patients enrolled, no cases of amyloid-related imaging abnormalities (ARIA) reported, and no patient dropouts [2][9] - The company has strengthened its financial position by raising approximately $21.6 million in gross proceeds in July 2025 [2][14] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing antibody therapeutics targeting toxic misfolded proteins associated with neurodegenerative diseases, including Alzheimer's disease, ALS, and Parkinson's disease [10] - The company's proprietary platform, EpiSelect™, is designed to identify conformational epitopes on toxic misfolded proteins, enabling the generation of selective therapeutic antibodies [4][10] Clinical Development - PMN310 is a humanized IgG1 monoclonal antibody specifically targeting toxic amyloid-beta oligomers (AβO), which are believed to be a major driver of Alzheimer's disease [5][11] - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, and pharmacokinetics of PMN310, with interim results expected in Q2 2026 and final results in Q4 2026 [12][9] Financial Performance - As of June 30, 2025, ProMIS reported cash and cash equivalents of $4.5 million, an increase from $1.0 million a year earlier [14] - Research and development expenses for Q2 2025 were $8.7 million, significantly higher than $1.6 million in the same period of 2024, primarily due to costs associated with the PRECISE-AD trial [14][20] - The net loss for Q2 2025 was $10.1 million, compared to a net loss of $2.6 million in Q2 2024, reflecting increased clinical trial expenditures [14][20]
Annovis Provides Corporate Updates and Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-08-12 20:05
Core Viewpoint - Annovis Bio, Inc. is advancing its pivotal Phase 3 trial for early Alzheimer's disease, with significant progress in patient enrollment and global intellectual property protection [2][6]. Clinical Highlights - The pivotal Phase 3 study in early Alzheimer's disease has secured 76 clinical sites in the U.S. and has screened over 400 patients, with 38 patients currently receiving treatment [2][6]. - The screen failure rate for the trial is as expected at 50% [6]. - Annovis presented four scientific posters at AAIC 2025, showcasing advancements in the Alzheimer's Phase 3 study and the pharmacokinetic profile of its lead drug candidate, buntanetap [6]. Business Highlights - The company has successfully transferred all patent families to crystal buntanetap, achieving comprehensive global intellectual property coverage [2][6]. - Annovis welcomed a new Director of Biostatistics to maintain the statistical integrity of clinical trial data [6]. - A webcast was hosted in June to provide updates on the Phase 3 trial, allowing for direct engagement with the audience [6]. Financial Results - As of June 30, 2025, Annovis reported cash and cash equivalents of $17.1 million, an increase from $10.6 million as of December 31, 2024 [6]. - Research and development expenses for Q2 2025 were $5.2 million, down from $5.8 million in Q2 2024 [6]. - General and administrative expenses decreased to $1.1 million in Q2 2025 from $2.0 million in Q2 2024 [6]. - The net loss per common share for Q2 2025 was $0.32, an improvement from a loss of $0.44 per share in Q2 2024 [6].
Annovis to Host Webinar and Live Q&A on June 24, 2025
GlobeNewswire News Room· 2025-06-05 12:00
Core Points - Annovis Bio, Inc. is a clinical-stage drug platform company focused on developing therapies for neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease [1][4] - The company will host a live webcast featuring updates on its pivotal Phase 3 trial in early Alzheimer's disease and feedback from the FDA regarding its Parkinson's disease program [2] - The webcast is open to various stakeholders including shareholders, patients, and investigators, allowing for direct engagement with the CEO [3] Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania, and aims to address neurodegeneration by targeting multiple neurotoxic proteins to restore brain function and improve patient quality of life [4] - The company encourages interested investors and shareholders to sign up for press releases and industry updates through its investor website [5]
Alector Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-08 20:05
Core Insights - Alector, Inc. is advancing its clinical pipeline for neurodegenerative diseases, with key trials expected to report results in late 2025 [1][2][5] - The company has extended its cash runway into the second half of 2027, with a total of $354.6 million in cash, cash equivalents, and investments as of March 31, 2025 [1][12] Clinical Developments - The pivotal INFRONT-3 Phase 3 trial of latozinemab for frontotemporal dementia with a granulin gene mutation is on track to report topline data in Q4 2025 [2][5] - Enrollment in the PROGRESS-AD Phase 2 trial of AL101/GSK4527226 for early Alzheimer's disease has been completed ahead of schedule [4][6] - Alector is pursuing its Alector Brain Carrier programs, which include an anti-amyloid beta antibody and GCase enzyme replacement therapy, both targeting validated genetic pathways [2][7] Financial Performance - Collaboration revenue for Q1 2025 was $3.7 million, a decrease from $15.9 million in Q1 2024, primarily due to the completion of obligations related to previous programs [9] - Total R&D expenses for Q1 2025 were $33.6 million, down from $45.2 million in the same quarter of 2024, reflecting cost management efforts [10] - The net loss for Q1 2025 was $40.5 million, or $0.41 per share, compared to a net loss of $36.1 million, or $0.38 per share, in Q1 2024 [11][20] Corporate Updates - Giacomo Salvadore, M.D., has been appointed as Chief Medical Officer, bringing over 15 years of experience in neurology-focused clinical development [8] - Alector continues to leverage its proprietary blood-brain barrier technology platform, Alector Brain Carrier, to enhance therapeutic delivery to the brain [7][15]
ZyVersa Therapeutics Announces Published Data Showing Inflammasome ASC Inhibitor IC 100 Decreases Microglial Inflammasome Activation and Alpha-Synuclein That Contribute to Neurodegeneration in Parkinson’s Disease
Globenewswire· 2025-04-29 11:57
Core Insights - ZyVersa Therapeutics, Inc. announces promising data for its Inflammasome ASC Inhibitor IC 100, which may slow the progression of Parkinson's disease [1][3] - The study published in npj Parkinson's Disease shows that IC 100 blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation, both critical in Parkinson's disease progression [2][7] Company Overview - ZyVersa is a clinical stage specialty biopharmaceutical company focused on developing first-in-class drugs for inflammatory and renal diseases, with a significant market opportunity exceeding $100 billion [10] - The company is advancing its lead candidate IC 100, a humanized IgG4 monoclonal antibody targeting inflammasome adaptor protein ASC, which is designed to mitigate inflammatory responses [6][10] Study Findings - The research indicates that IC 100 uniquely inhibits ASC speck activity and misfolded protein aggregates, making it a strong candidate for treating neurodegenerative diseases, including Lewy body dementia and Alzheimer's Disease [5] - The study highlights the presence of ASC and NLRP1 in alpha-synuclein aggregates in neuronal Lewy bodies, suggesting a link between inflammasome activation and neurodegeneration in Parkinson's disease [8] Market Context - The global Parkinson's disease drug market was valued at $6.6 billion in 2024 and is projected to reach $13.3 billion by 2034, indicating significant growth potential for innovative treatments [7]