POTOMAC, MARYLAND / ACCESS Newswire / December 9, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced it has reached a key enrollment milestone of 65% for its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's disease. This milestone marks a significant... Read more
ARO-MAPT utilizes the Targeted RNAi Molecule (TRiM™) platform designed for subcutaneous administration and systemic delivery to the CNS by crossing the blood-brain-barrier Study initiation further highlights Arrowhead’s innovation and leadership in the delivery of siRNA PASADENA, Calif. / Dec 08, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has dosed the first subjects in a Phase 1/2a clinical trial of ARO-MAPT, the... Read more
Long-term LEQEMBI treatment suggests potential to delay disease progression from Mild Cognitive Impairment (MCI) to moderate Alzheimer's disease by up to 8.3 years in low-amyloid group who started treatment at an early stage New safety and efficacy data presented at scientific symposium on subcutaneous formulation for LEQEMBI initiation treatment, which is under regulatory review in the United States TOKYO and CAMBRIDGE, Mass., Dec. 3, 2025 /PRNewswire/ -- Eisai... Read more
FDA feedback provides clear framework for Nexalin’s planned U.S. Pilot Study and supports a potential De Novo pathway for the Gen-2 SYNC™ device in Alzheimer’s disease HOUSTON, TX, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced the successful completion of a substantive Q-Submission (“Q-Sub”) meeting... Read more
Study Continuation Follows Review of Site Level Data and Recommendation of Data Monitoring Committee BMS Remains Blinded to Study Data PRINCETON, N.J. / Dec 03, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY, “BMS”) today announced that it will enroll additional patients in the ADEPT-2 study. As part of its commitment to upholding the highest standards in clinical research and following a thorough blinded review of the ADEPT-2 study data, the company identified... Read more
TOKYO and CAMBRIDGE, Mass., Dec. 2, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the latest data confirming the pharmacological effect of lecanemab (generic name, U.S. brand name: LEQEMBI®), an anti-Aβ protofibril* antibody, on Aβ protofibrils (PF) in cerebrospinal fluid (CSF) was... Read more
Results obtained in the Phase 2 placebo-controlled CLEAR-MIND clinical trial showed that treatment with stem cell therapy laromestrocel was associated with a reduction in MRI measured neuroinflammation compared to placebo across multiple key brain regions, including key Alzheimer’s disease-associated regions, most notably in the hippocampus Reduction in hippocampal neuroinflammation, measured using MRI assessed free water, correlated strongly with preservation of... Read more
POTOMAC, MD / ACCESS Newswire / November 25, 2025 / IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American:IGC), a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's disease, today announced advances in MINT-AD, the Multimodal Interpretable Transformer for Alzheimer's. Leveraging data from the Health and Retirement Study (HRS) International Family of Studies, IGC Pharma aims to identify unknown socioeconomic... Read more
Data demonstrate a favorable bioavailability profile of INM-901 oral formulation Data will support design and planning of first in human clinical trials Preparing for pre-IND meeting with the FDA Vancouver, British Columbia--(Newsfile Corp. - November 18, 2025) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company developing a pipeline of proprietary small-molecule drug candidates for diseases with high unmet medical needs,... Read more
Company plans to request re-examination after CHMP opinion feedback following its oral explanation FDA advises Company to meet and discuss Company’s Alzheimer's Disease clinical trial results NEW YORK, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, ne... Read more
POTOMAC, MARYLAND / ACCESS Newswire / November 13, 2025 / IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American:IGC), a clinical-stage biotechnology company leveraging Artificial Intelligence ("AI") to develop innovative treatments for Alzheimer's disease, today announced that the United States Patent and Trademark Office ("USPTO") has granted the company U.S. Patent No. 12,465,589, titled "Methods and Composition for Treating CNS Disorders." The patent... Read more
Study conducted in collaboration with the Alzheimer’s Clinical Trials Consortium PURCHASE, N.Y., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the company has reached target enrollment of 540 participants in the randomized, placebo-controlled Phase 2 ‘START’ Study. A number of additional patients are in... Read more
This strategic filing with the FDA follows encouraging internal data and recent published studies supporting Nexalin’s frequency neurostimulator as a potential non-invasive therapy for cognitive disorders associated with Alzheimer’s disease HOUSTON, TX, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced that the... Read more
ADAS-Cog13 difference −12.78 (P < 0.0001) with oral blarcamesine treatment compared to ADNI control group at Week 144 77.4 Weeks (17.8 Months) ‘time saved’ with oral blarcamesine compared to ADNI Restoring impaired Autophagy − preceding amyloid-beta and tau NEW YORK, Oct. 29, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative... Read more
PDUFA Date Set for August 13, 2026 BEDFORD, Mass., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MK-6240, the company’s investigational F18-labeled tau-targeted... Read more
The Quest AD-Detect® blood-based test panels deliver confirmatory accuracy, potentially supporting reduced reliance on PET-imaging confirmation SECAUCUS, N.J., Oct. 27, 2025 /PRNewswire/ -- Two blood tests, each involving multiple biomarkers, are highly accurate at identifying Alzheimer's disease pathology in symptomatic patients, supporting diagnosis, according to a new study in Neurology® Clinical Practice, a publication of the American Academy of Neurolo... Read more
Labcorp plans to make Roche's Elecsys® pTau181 test available nationwide by early 2026 BURLINGTON, N.C., Oct. 23, 2025 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today it will offer the Elecsys pTau181 test, the only blood test cleared by the U.S. Food and Drug Administration (FDA) to aid in the initial assessment for Alzheimer's disease and other causes of cognitive decline in the primary-care... Read more
Three Independent Studies Published in “Alzheimer’s Research & Therapy,” “Journal of Alzheimer’s Disease,” and “Radiology” Validate Nexalin’s Non-Invasive Approach with Consistent Cognitive and Neuroimaging Benefits HOUSTON, TX, Oct. 21, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced that three i... Read more
Rules out Alzheimer's pathology in early stages to enhance diagnostic pathway efficiency Provides new opportunity to broaden access and improve referral quality Features as part of Roche's growing portfolio designed to further shape Alzheimer's diagnostic pathways INDIANAPOLIS, Oct. 13, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States Food and Drug Administration (FDA) has cleared its Elecsys pTau181 test, the only... Read more
MALVERN, Pa., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced new results that demonstrate buntanetap’s ability to attenuate inflammation and improve cellular health in Alzheimer’s patients, suggesting potential disease-modifying... Read more
40-Hz DIFS™ significantly improves cognitive performance and brain connectivity in peer-reviewed clinical trial Results published in Radiology, the flagship journal of the Radiological Society of North America (RSNA) HOUSTON, TX, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced the publication of additional... Read more
IGC-1C Targets Tau Protein's Liquid-Liquid Phase Separation (LLPS), Posing a Novel Threat to Neurotoxic Tangles; High Binding Affinity Confirmed POTOMAC, MD, 1734 / ACCESS Newswire / October 7, 2025 / IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American:IGC), a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's disease, today announced in-vitro findings for IGC-1C, a low-molecular weight compound.... Read more
New LEQEMBI CompanionTM program launched to expand helpful resources for patients throughout the treatment journey, including Nurse Educators who can provide patients with injection training, and an injection tracking tool and more LEQEMBI IQLIK, approved by the U.S. FDA in August 2025, is the first and only anti-amyloid treatment to offer an at-home injection after initial treatment of 18 months TOKYO and CAMBRIDGE, Mass., Oct. 6, 2025 /PRNewswire/ -- Eisai... Read more
CAMBRIDGE, Mass., Oct. 6, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced new positive findings based on plasma samples from its Phase-2b PARADIGM study. These results indicate that PrimeC produced robust, statistically significant reductions in multiple microRNAs that are consistently implicated in Alzheimer's... Read more
Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease Fast Track Designation recognizes the potential of anti-MTBR tau to be an important treatment option for patients with Alzheimer’s disease PRINCETON, N.J. / Oct 01, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to... Read more
POTOMAC, MD / ACCESS Newswire / September 29, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the addition of a new clinical trial site to its ongoing Phase 2 study evaluating IGC-AD1, an investigational drug candidate for treating agitation in Alzheimer's disease. The new site, Ichor Research, located in Syracuse, New York, is led by Principal Investigator Dr. Karl F. Hafner, M.D. Dr. Hafner brings years of experience in clinical research and patient care,... Read more
TOKYO and CAMBRIDGE, Mass., Sept. 28, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name in China: “乐意保®”, generic name: lecanemab) has been approved for once every four weeks... Read more
Approved for earliest symptomatic stages of disease, demonstrating significant slowing of cognitive and functional decline Only therapy with evidence to support completing course of treatment once amyloid plaques are reduced to minimal levels INDIANAPOLIS, Sept. 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Commission (EC) has granted marketing authorization for Kisunla (donanemab) for the treatment of early symptomatic... Read more
TOKYO and CAMBRIDGE, Mass., Sept. 24, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Therapeutic Goods Administration (TGA) of Australia has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name, generic name: lecanemab)... Read more
Initial Phase 2 RoAD trial results demonstrate improvements in brain-cell connectivity and health, with a favorable safety profile CAMBRIDGE, Mass., Sept. 10, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced positive initial results from its collaboration with NeuroKaire in the ongoing RoAD Phase 2... Read more
In preclinical studies presented today at the RNA Leaders USA Congress 2025, investigational ARO-MAPT demonstrated potent and long-lasting MAPT mRNA and Tau protein suppression with uniform distribution throughout the CNS after subcutaneous administration in non-human primates PASADENA, Calif. / Sep 10, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has filed a request for regulatory clearance to initiate a Phase 1/2a clinical... Read more
PURCHASE, N.Y., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the Phase 2 ‘START’ Study has reached the 75% enrollment mark. The START Study is enrolling approximately 540 individuals with mild cognitive impairment (MCI) and early Alzheimer’s disease who will be treated with zervimesine (CT1812) or placebo for... Read more
Cohort 2 fully enrolled; enrollment and dosing now underway for Cohort 3 (final dose level); No cases of amyloid-related imaging abnormalities (ARIA) observed to date; The trial, expected to enroll 128 patients, remains on track to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026. Cambridge, Massachusetts, Sept. 03, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a clinical-stage biotechnology company developing... Read more
LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start to help patients and care partners treat this progressive, relentless disease TOKYO and CAMBRIDGE, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, ��... Read more
LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after initial treatment of 18 months LEQEMBI IQLIK will be launched on October 6, 2025, in the U.S. TOKYO and CAMBRIDGE, Mass., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge,... Read more
Manuscript featured in leading open-access scientific journal Alzheimer’s Research & Therapy SARASOTA, FL, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company), a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company, today announced the publication of preclinical research for its Alzheimer’s disease (AD) therapeutic, SPC-14, in Alzheimer’s Research & Therapy, an international... Read more
Lumipulse® pTau-217/Beta Amyloid 42 Ratio now available nationwide through Labcorp BURLINGTON, N.C., Aug. 18, 2025 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first blood-based in-vitro diagnostic (IVD) test cleared by the U.S. Food and Drug Administration (FDA) to aid in the diagnosis of Alzheimer's disease through early... Read more
Positions IGC at the intersection of biotech innovation and cannabinoid science in one of the largest unmet medical needs in the world Alzheimer's affects over 50 million people globally, with more than 400 million at risk from underlying disease pathology POTOMAC, MARYLAND / ACCESS Newswire / August 12, 2025 / IGC Pharma, Inc. ("IGC" or the "Company") (NYSE American:IGC) today announced promising preclinical results for IGC-M3, a novel small molecule designed... Read more
New hope in Alzheimer's: IGC-M3 targets the disease on four fronts, showing promise in cellular models POTOMAC, MD / ACCESS Newswire / August 5, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage pharmaceutical company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders, today announced encouraging preclinical data on its investigational molecule "IGC-M3". The invitro results demonstrates that... Read more
New clinical Precision Medicine population data demonstrates up to 84.6 Weeks (19.5 Months) ‘time saved’ by early-start ADAS-Cog13 difference: −5.43 (P = 0.0035), ADCS-ADL difference: +9.50 (P < 0.0001) Restoring impaired autophagy as early event, preceding amyloid-beta and tau Oral presentation at the Alzheimer’s Association International Conference (AAIC) 2025 NEW YORK, July 31, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the... Read more
Data Showed LEQEMBI Slowed Clinical Decline by 1.75 Points on CDR-SB at Four Years Compared to the Natural History of Alzheimer's Disease 56% of Patients with Low Tau Continued to Demonstrate Improved Cognitive and Daily Living Function at Four Years TOKYO and CAMBRIDGE, Mass., July 30, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO:... Read more
Findings from the TRAILBLAZER-ALZ 2 long-term extension study highlight Kisunla continued to demonstrate slowing of decline, with most participants having completed treatment Data underscores the value of early intervention and supports a limited duration dosing approach with sustained long-term benefits INDIANAPOLIS, July 30, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced results from the long-term extension (LTE) of the Phase 3 TRAILBLAZER-ALZ... Read more
VANCOUVER, British Columbia & DALLAS / Jul 29, 2025 / Business Wire / Alpha Cognition Inc. (Nasdaq: ACOG) (“Alpha Cognition” [ACI], or the “Company”), a biopharmaceutical company developing novel therapies for debilitating neurodegenerative disorders, today announced China Medical System Holdings Limited (CMS) New Drug Application (NDA) for ZUNVEYL has been accepted by the National Medical Products Administration of China (NMPA) for review for the treatment of... Read more
NEWTON, Mass., July 28, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced results showing that implementing a blood-based pTau217 screening assay reduced Acumen’s overall clinical trial screening costs by approximately 40% in its Phase 2 ALTITUDE-AD study... Read more
Trontinemab’s Phase Ib/IIa Brainshuttle™ AD study continues to show rapid and robust clearance of amyloid plaques, with 91% becoming amyloid PET negative and ARIA-E remaining <5% Design of the Phase III TRONTIER 1 and 2 studies of trontinemab in early symptomatic Alzheimer’s disease featured, with initiation planned in 2025 Plans for new Phase III trial investigating trontinemab in preclinical Alzheimer’s disease, in people at high risk of cognitive... Read more
The opinion will now be referred to the European Commission for final regulatory decision on donanemab INDIANAPOLIS, July 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending donanemab for the treatment of early symptomatic Alzheimer's disease in adults with confirmed amyloid pathology who are... Read more
Company to showcase innovations in AI-driven drug discovery and early disease detection, including solutions for low resource settings POTOMAC, MARYLAND / ACCESS Newswire / July 23, 2025 / IGC Pharma, Inc. (NYSE American:IGC), a clinical-stage biopharmaceutical company focused on Alzheimer's disease, today announced the presentation of three scientific posters at the 2025 Alzheimer's Association International Conference ("AAIC"), taking place July 27-31 in Toronto,... Read more
SANTA ANA, Calif., July 22, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced that it will present on the mechanism of action for troculeucel, enhanced non-genetically modified NK cell therapy, in Alzheimer’s disease during a poster presentation... Read more
NewAmsterdam to host conference call at 10:00 a.m. ET on Wednesday, July 30th NAARDEN, the Netherlands and MIAMI, July 22, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C), for whom existing therapies are... Read more
Lecanemab presentations to include long-term Clarity AD data, real-world treatment insights, and a subcutaneous formulation for continued care Presentations on tau to explore its biological role, the development of targeted therapies and biomarkers, and the future integration of these innovations into clinical practice CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer’s... Read more