latozinemab (AL001)
Search documents
ALEC Investors Have Opportunity to Join Alector, Inc. Fraud Investigation with the Schall Law Firm
Businesswire· 2025-11-12 03:43
Core Viewpoint - Alector, Inc. is under investigation by the Schall Law Firm for potential violations of securities laws following disappointing results from a clinical trial, which led to a significant drop in its stock price [2][3]. Group 1: Investigation Details - The Schall Law Firm is investigating claims on behalf of Alector investors regarding false or misleading statements made by the company [2]. - Alector's press release on October 21, 2025, revealed that its drug candidate, latozinemab (AL001), failed to meet the primary endpoint in a Phase 3 clinical trial for frontotemporal dementia, resulting in a nearly 50% drop in share price the following day [2][3]. Group 2: Legal Representation - The Schall Law Firm specializes in securities class action lawsuits and is encouraging affected shareholders to participate in the investigation [3]. - Investors can contact the Schall Law Firm for a free discussion about their rights [3].
Alector Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-06 21:05
Core Insights - Alector, Inc. is advancing its innovative drug candidates targeting neurodegenerative diseases, focusing on its Alector Brain Carrier (ABC) platform for enhanced delivery of therapeutics to the brain [2][3] Financial Overview - As of September 30, 2025, Alector reported cash, cash equivalents, and investments totaling $291.1 million, which is expected to fund operations through 2027 [15] - Collaboration revenue for Q3 2025 was $3.3 million, a significant decrease from $15.3 million in Q3 2024, primarily due to the completion of performance obligations related to previous programs [9] - Total research and development expenses for Q3 2025 were $29.4 million, down from $48.0 million in Q3 2024, attributed to reduced spending on specific programs and workforce reductions [10] - General and administrative expenses for Q3 2025 were $11.5 million, compared to $15.8 million in Q3 2024, reflecting cost-saving measures [13] - A net loss of $34.7 million was reported for Q3 2025, an improvement from a net loss of $42.2 million in Q3 2024 [14] Drug Development Pipeline - Alector has selected AL137 as the lead candidate for its ABC-enabled anti-amyloid beta antibody in Alzheimer's disease, with an IND filing targeted for 2026 [4] - The company is also advancing AL050, an ABC-enabled GCase enzyme replacement therapy for Parkinson's disease, with an IND submission planned for 2027 [11] - The ABC platform is designed to facilitate the delivery of antibodies, enzymes, and siRNA to the brain, demonstrating robust brain penetration and favorable safety profiles [2][3] Clinical Trials and Collaborations - The PROGRESS-AD Phase 2 clinical trial for nivisnebart (AL101) in early Alzheimer's disease is ongoing, with an independent interim analysis planned for the first half of 2026 [12] - Alector and GSK are collaborating on the development of nivisnebart, which aims to elevate progranulin concentrations in the brain [12][6] - The INFRONT-3 Phase 3 trial for latozinemab did not show clinical benefit, leading to the discontinuation of further studies for this candidate [7] Strategic Focus - Alector has implemented a workforce reduction of approximately 47% to concentrate resources on high-priority programs and extend its cash runway [8] - The company continues to anticipate collaboration revenue between $13 million and $18 million for the year, with total R&D expenses projected between $130 million and $140 million [16]
Alector Announces Topline Results from Phase 3 INFRONT-3 Clinical Trial Evaluating Latozinemab
Yahoo Finance· 2025-10-31 09:42
Core Insights - Alector Inc. is highlighted as a promising investment opportunity under $3, particularly following the announcement of topline results from the Phase 3 INFRONT-3 clinical trial for its drug latozinemab (AL001) targeting frontotemporal dementia due to a progranulin gene mutation [1][4] Clinical Trial Results - The INFRONT-3 trial, a 96-week double-blind study conducted in collaboration with GSK, did not achieve its primary endpoint of slowing the progression of frontotemporal dementia as measured by the Clinical Dementia Rating plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes [2][3] Future Developments - Alector is also involved in the PROGRESS-AD trial, a global 76-week Phase 2 study evaluating nivisnebart (AL101/GSK4527226) for early Alzheimer's disease, with enrollment completed in April 2025 and trial completion expected in 2026, including an independent interim analysis planned for H1 2026 [3]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Alector, Inc. - ALEC
Prnewswire· 2025-10-28 14:00
Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Alector, Inc. following disappointing clinical trial results for its drug, latozinemab, which did not meet primary endpoints [1][2]. Group 1: Company Overview - Alector, Inc. is a biotechnology company focused on developing therapies for neurodegenerative diseases [2]. - The company recently announced results from the Phase 3 INFRONT-3 clinical trial for latozinemab, which targets frontotemporal dementia due to a progranulin gene mutation [2]. Group 2: Clinical Trial Results - The Phase 3 clinical trial results indicated that latozinemab failed to meet its clinical co-primary endpoint of slowing the progression of frontotemporal dementia [2]. - Secondary and exploratory endpoints, including fluid biomarkers and volumetric magnetic resonance imaging (vMRI), showed no treatment-related effects [2]. Group 3: Market Reaction - Following the announcement of the trial results, Alector's stock price dropped by $1.60 per share, representing a decline of 49.84%, closing at $1.61 per share on October 22, 2025 [2].
Clinical Failure Halts Alector's Dementia Program, Company Reduces Workforce
Benzinga· 2025-10-22 16:07
Core Insights - Alector, Inc. announced results from the Phase 3 INFRONT-3 trial for latozinemab (AL001) targeting frontotemporal dementia caused by a progranulin gene mutation, which did not meet its primary clinical endpoint [1][2] Trial Results - The 96-week study did not achieve the co-primary endpoint of slowing FTD-GRN progression as measured by the Clinical Dementia Rating plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes [2] - Although there was a statistically significant effect on the biomarker co-primary endpoint of plasma progranulin concentrations, secondary and exploratory endpoints showed no treatment-related effects on FTD-GRN [3] - Preliminary safety data did not indicate major safety concerns, but further analysis is ongoing [3] Future Plans - The open-label extension of the INFRONT-3 trial and the continuation study for latozinemab will be discontinued based on the trial results [4] - Alector is collaborating with GSK on nivisnebart (AL101/GSK4527226) in a 76-week Phase 2 trial for early Alzheimer's disease, with trial completion expected in 2026 [5] Financial Outlook - As of September 30, 2025, Alector has approximately $291.1 million in cash and equivalents, expected to provide financial runway through 2027 [6] Analyst Commentary - William Blair downgraded Alector from Outperform to Market Perform, with analyst Myles Minter removing latozinemab from the FTD-GRN opportunity [7] - Despite observing plasma and CNS PGRN elevations to normal levels, the link between PGRN insufficiency and FTD-GRN remains uncertain [7] Stock Performance - Following the announcement, Alector shares fell by 51.09% to $1.57, nearing a 52-week low of $0.87 [8]
Alector Announces Topline Results from Latozinemab Phase 3 Trial in Individuals with Frontotemporal Dementia Due to a GRN Mutation and Provides Business Update
Globenewswire· 2025-10-21 20:05
Core Insights - Alector, Inc. announced that its Phase 3 INFRONT-3 clinical trial of latozinemab (AL001) for frontotemporal dementia due to a progranulin gene mutation did not meet its primary clinical endpoint, although it showed a significant effect on plasma progranulin biomarker levels [2][3][14] Company Updates - The INFRONT-3 trial was a 96-week, double-blind study that failed to demonstrate clinical benefits in slowing disease progression, leading to the discontinuation of the open-label extension and continuation study for latozinemab [2][3] - Alector's pipeline includes ongoing collaboration with GSK on nivisnebart (AL101/GSK4527226) in a Phase 2 trial for early Alzheimer's disease, with completion expected in 2026 [6] - Alector is advancing multiple preclinical programs, including AL137 for anti-amyloid beta therapy and AL050 for enzyme replacement therapy in Parkinson's disease, with IND submissions targeted for 2026 and 2027 respectively [8][9] - The company is also developing a proprietary blood-brain barrier technology platform, Alector Brain Carrier (ABC), aimed at enhancing therapeutic delivery to the brain [7][17] Leadership and Workforce Changes - Alector is reducing its workforce by approximately 49% to focus resources on high-priority programs [10][11] - Sara Kenkare-Mitra, President and Head of R&D, will resign effective December 22, 2025, after contributing significantly to the company's R&D efforts [12][13] Financial Position - As of September 30, 2025, Alector reported approximately $291.1 million in cash and equivalents, expected to fund operations through 2027 [13]