POTOMAC, MARYLAND / ACCESS Newswire / April 8, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") today announced the expansion of its ongoing Phase 2 CALMA clinical trial with the addition of Butler Hospital's Memory and Aging Program, a nationally recognized research center affiliated with the Warren Alpert Medical School of Brown University, in Providence, Rhode Island. The site will support enrollment for the CALMA study evaluating IGC-AD1,... Read more
ATTENTION-AD trial data through 192 weeks presented at AD/PDTM 2025 Conference Prespecified delayed-start analysis indicate disease-modifying effect of oral blarcamesine and importance of early and continued long-term treatment of chronic Alzheimer’s disease Blarcamesine exhibited a favorable safety profile with no treatment-related deaths NEW YORK, April 05, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL),... Read more
Late-breaking oral presentation of results from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation Presentation featuring network meta-analysis of SYMBRAVO® versus oral CGRPs NEW YORK, April 04, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced multiple presentations spanning its innovative,... Read more
New trontinemab data continue to support rapid and deep, dose-dependent reduction of amyloid plaques in Phase Ib/IIa Brainshuttle™ AD study Data on the Elecsys® pTau181 plasma test demonstrate potential to accurately rule out amyloid pathology, one of the hallmarks of Alzheimer’s disease A Phase III program for trontinemab later this year will be initiated based on totality of data SOUTH SAN FRANCISCO, Calif. / Apr 03, 2025 / Business Wire / Genentech, a member... Read more
NEW YORK, April 2, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused clinical-stage biopharmaceutical company, today announced its collaboration with Washington University School of Medicine in St. Louis to advance Alzheimer's disease research through a novel therapeutic strategy. The partnership centers on a recently submitted NIH grant proposal focused on studying HT-ALZ—an FDA-approved NK-1 receptor antagonist—for its potential to reduce... Read more
Results underscore the dual-action profile of HT-ALZ—impacting both pathology and symptomology. NEW YORK, April 2, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company focused on developing innovative treatments for unmet medical needs, today announced groundbreaking preclinical data supporting the therapeutic potential of its lead Alzheimer's candidate, HT-ALZ, in improving cognitive function and reducing neuroinflammation... Read more
CAMBRIDGE, Mass., April 02, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer’s disease. Fast Track designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious conditions and address unmet medical... Read more
Labcorp's pTau-217/Beta Amyloid 42 Ratio blood test meets the performance criteria to confirm amyloid pathology consistent with Alzheimer's disease BURLINGTON, N.C., April 2, 2025 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the nationwide launch of its pTau-217/Beta Amyloid 42 Ratio, a powerful new blood-based biomarker test to aid in the diagnosis of Alzheimer's disease. The new test... Read more
BOSTON, April 01, 2025 (GLOBE NEWSWIRE) -- NeuroNOS, a pioneering biopharmaceutical company developing transformative treatments for complex neurological disorders, including Autism Spectrum Disorder (ASD), brain cancers, and Alzheimer’s disease, and a subsidiary of Beyond Air (NASDAQ: XAIR), proudly announces the publication of breakthrough research by its Chief Scientific Officer, Prof. Haitham Amal, in Translational Psychiatry, a peer-reviewed medical journal published... Read more
New tools to connect with independent in-person and telehealth providers specializing in Alzheimer's disease are designed to increase capacity and reduce delays in diagnosis INDIANAPOLIS, March 27, 2025 /PRNewswire/ -- Eli Lilly and Company (LLY) has expanded its LillyDirect digital healthcare platform to offer connections to independent in-person and telehealth options for people in the U.S. living with Alzheimer's disease, the majority of whom have not been formally... Read more
NEWTON, Mass., March 26, 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 the completion of enrollment in its ALTITUDE-AD Phase 2 trial of sabirnetug (ACU193) in patients with early Alzheimer’s disease. Acumen completed enrollment ahead of schedule and plans... Read more
Simufilam did not show a significant reduction in co-primary endpoints of cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer’s disease Simufilam continued to demonstrate an overall favorable safety profile Cassava’s Alzheimer’s disease development program with simufilam will be completely discontinued by the end of Q2 2025 AUSTIN, Texas, March 25, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”,... Read more
Planned single, pivotal Phase 2/3 clinical trial, if positive, acceptable for Biological License Application (BLA) submission for Alzheimer’s disease Alignment with FDA on proposed trial study design, population and endpoints Initiation of planned pivotal Phase 2/3 clinical trial anticipated in 2H 2026, contingent upon obtaining non-dilutive funding and/or partnering support Laromestrocel (Lomecel-B™) has received FDA Regenerative Medicine Advanced Therapy (RMAT)... Read more
ZUNVEYL is the first oral FDA-approved treatment for Alzheimer’s disease in the past decade 32 person sales team hired to cover the $2 billion Long-Term-Care market All launch activities delivered on-time and on-budget, positioning ZUNVEYL for success VANCOUVER, British Columbia & DALLAS / Mar 18, 2025 / Business Wire / Alpha Cognition Inc. (Nasdaq: ACOG), a biopharmaceutical company dedicated to advancing treatments for neurodegenerative diseases, today announced... Read more
Alzheimer’s disease (AD), affecting around 6.9 million people in the US, is ranked as the seventh leading cause of death and is the most common cause of dementia among older adults. AD begins with buildup of amyloid beta (Aβ) plaques and neurofibrillary tangles in the brain that causes brain cells to die over time and the brain to shrink. The data demonstrate that initial deposition of Aβ triggers NLRP3 inflammasome activation causing release of ASC specks which... Read more
TOKYO and CAMBRIDGE, Mass., Feb. 28, 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion by consensus for the anti-Aβ monoclonal antibody lecanemab, adopted in November... Read more
Rapid Enrollment and Dosing of First Patients Encouraging and Underscores Unmet Need for Better Treatment Options for Alzheimer’s Disease Six-month Interim Results Expected in 1H 2026 with Topline Results Anticipated in 2H 2026 CAMBRIDGE, Massachusetts, Feb. 25, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded... Read more
Chemical process enhances room temperature stability Provisional patent applications filed PURCHASE, N.Y., Feb. 20, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, today announced that the American Chemical Society journal Organic Process Research & Development has published a manuscript describing the novel... Read more
SANTA ANA, Calif., Feb. 19, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: 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 Anita Fletcher, M.D. has been appointed as the National Principal Investigator (“PI”) for its Phase 2a clinical trial of troculeucel, expanded enhanced... Read more
VANCOUVER / Feb 12, 2025 / Business Wire / Alpha Cognition Inc. (NASDAQ: ACOG) (“Alpha Cognition” (ACI), or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today announced that the United States Patent and Trademark Office (USPTO) has granted a new patent titled “Coated Tablets for pH-Dependent Release of Benzgalantamine.” This newly issued patent strengthens Alpha Cognition’s intellectual... Read more
The Fast Track designation accelerates troculeucel’s path to U.S. FDA submission for the treatment of patients with moderate Alzheimer’s disease. NKGen will benefit from increased FDA interactions, enhanced visibility and potential eligibility for Accelerated Approval, Priority Review, and Rolling Review of the regulatory dossier, with a faster path to market for troculeucel. SANTA ANA, Calif., Feb. 12, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq:... Read more
Investigator-initiated data from Houston Methodist Hospital showed LD IL-2 reduced proinflammatory factors, both systemically and within the central nervous system, while demonstrating statistically significant improvement in beta amyloid 42 clearance with stabilization of cognitive decline over a five-month treatment period Comprehensive data set will be presented and released throughout 2025 and in a peer reviewed publication HOUSTON / Feb 06, 2025 / Business Wire... Read more
TOKYO and CAMBRIDGE, Mass., Jan. 31, 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 an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD)... Read more
Safety, tolerability, pharmacokinetic, and pharmacodynamic profile supports continued development of VG-3927 as potential once-daily oral therapy for Alzheimer’s disease (AD) Robust and dose-dependent reductions of sTREM2 were achieved demonstrating sustained functional target engagement Company plans to advance VG-3927 into a Phase 2 trial in the third quarter of 2025; Selects 25mg QD oral as a dose that fully engages desired pharmacology WATERTOWN,... Read more
INM-901 significantly reduced pro-inflammatory cytokines associated with Alzheimer's Statistically significant reduction in neurodegeneration marker, neurofilament light chain ('NfL') mRNA profile showed a reduction of several key neuroinflammatory genes in the brain Vancouver, British Columbia--(Newsfile Corp. - January 21, 2025) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline... Read more
LEQEMBI is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option TOKYO and CAMBRIDGE, Mass., Jan. 13, 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 U.S. Food and Drug Administration (FDA)... Read more
Topline ATTENTION-AD trial: Patients showed improved cognition and function over three years Delayed-start analysis of treatment with oral blarcamesine was significant reflecting importance of early treatment initiation Blarcamesine exhibited a favorable safety profile with no treatment-related deaths NEW YORK, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company... Read more
CAMBRIDGE, Massachusetts, Jan. 10, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on developing precision therapies for neurodegenerative diseases, today announced the initiation of its Phase 1b clinical trial (PRECISE-AD) evaluating its lead therapeutic candidate, PMN310, in Alzheimer’s disease (AD). PMN310, a humanized IgG1 antibody, is engineered to selectively target toxic oligomers of amyloid-beta... Read more
Phase 1 INTERCEPT-AD data published in Journal of Prevention of Alzheimer’s Disease supports continued development of sabirnetug (ACU193) for treatment of early Alzheimer’s disease (AD) Sabirnetug demonstrated selective, dose-dependent target engagement of amyloid beta oligomers (AβOs), statistically significant amyloid plaque reduction within higher dose cohorts, and low overall levels of ARIA-E Phase 2 ALTITUDE-AD clinical trial of sabirnetug is ongoing with... Read more
VANCOUVER, British Columbia & DALLAS--(BUSINESS WIRE)-- Alpha Cognition, Inc. (Nasdaq: ACOG) (“ACI” or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, and China Medical System Holdings Limited (CMS) (867.HK), a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability in the People’s Republic of China, today announced an... Read more
Building on decades of the Company's Alzheimer's research, two differentiated investigational therapies aim to slow pathological tau in distinct populations Fast Track designations reinforce J&J's commitment to Alzheimer's disease development and the potential of its precision approach TITUSVILLE, N.J., Jan. 8, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation... Read more
ACCORD-2 Phase 3 trial in Alzheimer’s disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse) ACCORD-2 Phase 3 trial achieves key secondary endpoint compared to placebo (p=0.001, prevention of relapse of Alzheimer’s disease agitation) AXS-05 reduced worsening of Alzheimer’s disease overall compared to placebo in ACCORD-2 Phase 3 trial (p<0.001, CGI-S Alzheimer’s disease overall clinical status) ADVANCE-2 trial did not... Read more
Blarcamesine: Potential novel oral treatment to target upstream Alzheimer’s disease pathology through autophagy enhancement Submission based on favorable ANAVEX®2-73-AD-004 trial results in patients with early Alzheimer’s disease Once daily oral administration of blarcamesine meaningfully slowed clinical decline in early Alzheimer's disease patients, demonstrating a favorable safety profile with no associated neuroimaging adverse events NEW YORK, Dec. 23, 2024... Read more
China is the fourth major market where Kisunla has received approval Kisunla was first approved in the United States in July 2024, approved in Japan in September 2024 and then in Great Britain in October 2024 INDIANAPOLIS, Dec. 17, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the National Medical Products Administration (NMPA) in China has approved Kisunla™ (donanemab-azbt, 350 mg/20 mL every four... Read more
NEW YORK, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced a significant milestone in its clinical development program for Alzheimer’s disease. The Company has successfully dosed the first patient with moderate... Read more
TOKYO and CAMBRIDGE, Mass., Dec. 4, 2024 /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 Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI®" (lecanemab) for the treatment... Read more
New trials to evaluate IGC-AD1's potential impact on amyloid plaque, tau tangles, and cognitive decline in Alzheimer's disease Expanded research positions IGC-AD1 as a potential treatment targeting the underlying disease pathology of Alzheimer's POTOMAC, MARYLAND / ACCESSWIRE / December 2, 2024 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") announced today an expansion of its clinical research program for IGC-AD1, an investigational treatment... Read more
TOKYO and CAMBRIDGE, Mass., Nov. 27, 2024 /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 humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI®" has been launched in South Korea. LEQEMBI received the Ministry of Food and Drug Safety (MFDS) approval in May 2024... Read more
First marketing authorization submission for blarcamesine NEW YORK, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases,... Read more
SOUTH SAN FRANCISCO, Calif., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering novel, genetically validated therapies for the treatment of neurodegenerative diseases, today announced results from the INVOKE-2 Phase 2 clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). Treatment with AL002 resulted in sustained target... Read more
Interim results indicate cognitive improvement in the active treatment group compared to placebo No serious adverse events or deaths reported in the trial POTOMAC, Md. / Nov 25, 2024 / Business Wire / IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") today announced additional interim data from its ongoing Phase 2 clinical trial evaluating IGC-AD1. The trial focuses on agitation in Alzheimer's as its primary outcome, with cognition assessed as an... Read more
Dramatic 95% Reduction of Cognitive Decline in CT1812-treated Patients with Lower Plasma p-tau217 Correlated with Improvements in Key Indicators of Alzheimer’s Disease Biology Findings Support Disease-modifying Potential of CT1812 PURCHASE, N.Y., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (NASDAQ: CGTX), a clinical-stage company developing drugs to treat neurodegenerative disorders, provided an update on a biomarker1 analysis from... Read more
Simufilam did not show a significant reduction in cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer’s disease in the ReThink-ALZ Phase 3 study Simufilam continued to demonstrate an overall favorable safety profile Cassava intends to present the data at an upcoming medical meeting The Company will hold a webcast today, November 25, 2024, at 8:00 AM ET AUSTIN, Texas, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc.... Read more
Candidate VY1706 demonstrates significant reductions of tau at low doses in NHP study; IND and CTA filings anticipated in 2026 VY1706 is the fifth neuro gene therapy development candidate nominated leveraging Voyager’s IV-delivered, CNS-penetrant TRACER capsids LEXINGTON, Mass., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced that... Read more
Alzamend is developing AL001, a lithium product designed for enhanced safety and efficacy compared to currently available FDA-approved and marketed lithium therapies At a low dose, AL001 evidenced consistently higher lithium concentrations than lithium carbonate within critical brain regions comprising target tissue for efficacy, which may provide therapeutic benefits with less risk in multiple neurological disorders Data will guide upcoming “Lithium in Brain” Phase... Read more
TOKYO and CAMBRIDGE, Mass., Nov. 14, 2024 (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 a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aβ) monoclonal antibody... Read more
Boca Raton, Florida, Nov. 13, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc.(NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease announced today that it completed randomization of patients for its Phase 2 trial on Monday, November 11th. This global, blinded, randomized Phase 2 trial (the “AD02 trial”) is focused on patients with Early... Read more
First patient randomized in SERENITY At-Home trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia Received FDA feedback on protocol for TRANQUILITY In-Care trial of BXCL501 for agitation associated with Alzheimer’s dementia (AAD) Estimated 140 million annual acute agitation episodes associated with these conditions 1-3 NEW HAVEN, Conn., Nov. 12, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI),... Read more
Today’s presentation at CTAD, a leading international Alzheimer's conference, expands research supporting the value of ultra-low-field MRI in monitoring amyloid-related imaging abnormalities (ARIA). MADRID / Oct 31, 2024 / Business Wire / Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced... Read more
Data of Blarcamesine confirm upstream SIGMAR1 activation Presented as Late Breaking Oral Communications at Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2024 Oral, once daily blarcamesine meaningfully slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events NEW YORK, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”)... Read more
