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...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...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™...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...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...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...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...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...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...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...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...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...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...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...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...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...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...Read more
ROCHESTER, N.Y., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Vaccinex (Nasdaq: VCNX) today provided an update on new clinical findings from its SIGNAL-AD Phase 1b/2 trial of pepinemab antibody in Alzheimer’s disease. Vaccinex recently announced positive results of the phase 1b/2 study of its lead product, pepinemab, in early stages of Alzheimer’s disease (AD). The purpose of this report is to share additional data demonstrating stage-specific...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...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....Read more
New testing method highlights link between protofibrils and biomarkers for neurodegeneration Patient and caregiver perspectives on five-year treatment with lecanemab Utilization of blood biomarkers to predict brain amyloid accumulation in AHEAD study of preclinical AD TOKYO and CAMBRIDGE, Mass., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB,...Read more
Dose-dependent increase in neuroprotective APOE2 expression in all participants with ongoing durability at 12 months Consistent reductions across CSF tau biomarkers and tau PET in majority of participants LX1001 well tolerated across all dose cohorts with no reports of amyloid-related imaging abnormalities (ARIA) Company to host webcast today at 7:00 AM ET NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc....Read more
A change in the initiation of donanemab dosing, shifting one vial of donanemab from the first infusion to the third infusion, lowered ARIA-E to 14% compared to 24% in patients receiving the standard dosing regimen used in the pivotal Phase 3 clinical trial Reduction of amyloid plaque and P-tau217 on this modified titration was comparable to patients receiving the standard dosing regimen Lilly intends to submit this data to global...Read more
Findings offer potential mechanistic and clinical insights in the development of cellular therapy Lomecel-B™ for mild Alzheimer’s disease (AD) Lomecel-B™ capacity to inhibit MMP14 correlates with improved clinical and biomarker outcomes in mild AD Immunomodulatory and pro-vascular effects of Lomecel-B™ in mild AD potentially driven by ability to exert MMP14 inhibition which may protect TIE2 receptor integrity in human...Read more
Newly analyzed biomarker data from the initial dose-escalation Phase 1 AD trial found that troculeucel reduces GFAP, NfL, p-tau181, GDF-15, and LTBP2 levels, which are detectable up to 10 years before dementia symptoms appear according to recent reports. This suggests a potential role for the use of troculeucel in delaying or preventing dementia onset in asymptomatic individuals with detectable biomarkers. Preliminary analysis from the...Read more
Study met Primary and Secondary Endpoints for Safety and Regulatory T cell (Treg) Cell Population Enhancement, respectively, with no off-target effects on T effector lymphocytes, providing further evidence of target engagement Exploratory Endpoints demonstrated cognitive stabilization on treatment vs. cognitive declines on placebo for LD IL-2 dosing every 4 weeks (LD IL-2 q4wks), which was associated with significant improvement in...Read more
LucentADTM Complete improves on single biomarker tests, significantly reducing the intermediate zone, providing results for more patients BILLERICA, Mass. / Oct 28, 2024 / Business Wire / Lucent Diagnostics, a brand of Quanterix Corporation (NASDAQ: QTRX), has introduced LucentAD Complete, a new multi-marker blood test designed to help detect Alzheimer’s Disease (AD) in a broader range of patients. Recent Alzheimer’s Association...Read more
HOUSTON, TX, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) today announced publication of a landmark study titled, “Altered Neuronal Activity Patterns of the Prefrontal Cortex in Alzheimer’s Disease After Transcranial Alternating Current Stimulation (tACS): A Resting-State Functional Magnetic Resonance Imaging Studyi” in the Journal of Alzheimer's Disease. This study builds on...Read more
Aliada's lead compound, ALIA-1758, an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody, is a potential best-in-class therapy for Alzheimer's disease Acquisition also allows AbbVie to utilize Aliada's novel blood-brain barrier (BBB)-crossing technology to enhance discovery and development efforts across neuroscience NORTH CHICAGO, Ill. and BOSTON, Oct. 28, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Aliada Therapeutics today...Read more
Vancouver, British Columbia--(Newsfile Corp. - October 28, 2024) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, announced that it has filed an additional international patent application, under the Patent Cooperation Treaty (PCT), focused on the pharmaceutical...Read more
ROCHESTER, N.Y., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease (AD) and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced that it will present promising new efficacy and safety data for its randomized, double-blind, phase 1b/2 SIGNAL-AD study of pepinemab treatment for Alzheimer’s disease at...Read more
Great Britain is the third major market where donanemab has received approval Donanemab was first approved in the United States in July 2024 and then approved in Japan in September 2024 INDIANAPOLIS, Oct. 23, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion...Read more
NEW YORK, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced that interim data from the ongoing Phase 1/2 trial (NCT03634007) of LX1001 have been selected as a late-breaking oral presentation at the Clinical Trials on Alzheimer’s...Read more
HOUSTON, TX, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) today announced results from a clinical trial demonstrating improvements in memory and cognitive function for patients with mild Alzheimer’s disease using its proprietary Deep Intracranial Frequency Stimulation (DIFS) technology. The full results have been published in Alzheimer’s Research & Therapy, one of the...Read more
Data confirm the positive topline results announced in June 2023 identifying a maximum tolerated dose as assessed by an independent safety review committee Identified dose is unlikely to require lithium therapeutic drug monitoring Data will guide upcoming “Lithium in Brain” Phase II clinical trials in partnership with Massachusetts General Hospital, which were announced in August 2024 ATLANTA / Oct 16, 2024 / Business Wire / Alzamend...Read more
NEW YORK, Oct. 15, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing innovative treatments, is proud to announce the granting of a U.S. patent for its pioneering Alzheimer's treatment, HT-ALZ. This milestone patent secures the company's intellectual property rights to its novel therapeutic approach, as Hoth accelerates preparations for clinical...Read more
In the Phase 2 LIGHTWAVE Study, dalzanemdor (SAGE-718) did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the primary endpoint Dalzanemdor was generally well-tolerated and no new safety signals were observed Topline data from the Phase 2 DIMENSION Study of dalzanemdor in Huntington’s Disease expected later this year CAMBRIDGE, Mass. / Oct 08, 2024 /...Read more
APOE genotyping allows assessment of a patient’s risk for adverse effects from new anti-amyloid therapy for Alzheimer’s WALTHAM, Mass. / Oct 02, 2024 / Business Wire / Revvity, Inc. (NYSE: RVTY), announced today the launch of the in-vitro diagnostic EURORealTimeTM APOE assay in European countries that accept the CE mark, which will enable accurate genotyping of the APOE gene. APOE genotyping is valuable to assess a patient’s risk for...Read more
Boca Raton, Florida, Sept. 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s Disease (AD), announced today that it closed enrollment for its Phase 2 trial on Friday, 27 September. This global, blinded, randomized Phase 2 trial (the “AD02 trial”) is focused on...Read more
Agreement builds upon a successful collaboration supporting the manufacture of sabirnetug (ACU193) drug substance (DS) for clinical studies in Alzheimer’s disease Extension to provide drug product (DP) manufacturing services for clinical and potential commercial supply from Lonza’s Visp, Switzerland site NEWTON, Mass., and BASEL, Switzerland, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a...Read more
Japan is the second major market where Kisunla has received approval Kisunla was first approved in the United States in July 2024 INDIANAPOLIS, Sept. 24, 2024 /PRNewswire/ -- The Ministry of Health, Labour and Welfare Japan has approved Kisunla™ (donanemab-azbt, 350 mg/20 mL every four weeks injection for IV infusion), Eli Lilly and Company's (NYSE: LLY) Alzheimer's treatment for adults with early symptomatic Alzheimer's disease...Read more
IGC-AD1 demonstrates the potential to modify tau and improve spatial memory Data supports the initiation of clinical trials investigating IGC-AD1 as a treatment for Alzheimer's disease POTOMAC, Md. / Sep 18, 2024 / Business Wire / IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") today announced data that reinforces the therapeutic potential of IGC-AD1 as a disease-modifying treatment for Alzheimer's disease. The...Read more
BOCA RATON, Fla., Sept. 17, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, today announced that results of additional analysis of blinded data from its AD02 Phase II Alzheimer's Disease (AD) trial demonstrated exceptional performance of the novel cognitive measure EMACC, as well as highly significant correlation between EMACC and the Clinical...Read more
Early observations suggest that the vehicle-treated Alzheimer's mice exhibit a larger population of reactive astrocytes, while the HT-ALZ treated groups show fewer reactive astrocytes, pointing to a potential breakthrough in the treatment of Alzheimer's. NEW YORK, Sept. 17, 2024 /PRNewswire/...Read more
Venlo, the Netherlands, Sept. 04, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has entered into a collaboration with Eli Lilly and Company to support the development of a QIAstat-Dx in-vitro diagnostic (IVD) to detect APOE genotypes which can play a role in the diagnosis of Alzheimer’s disease. This collaboration represents a significant milestone as the QIAstat-Dx panel would be the first...Read more
POTOMAC, Md. / Sep 04, 2024 / Business Wire / IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") announced today that the Company is advancing its proprietary formulation, IGC-AD1, toward clinical trials as a potential anti-amyloid disease-modifying treatment for Alzheimer's disease. Following the FDA's 2023 approval of two groundbreaking anti-amyloid drugs, Donanemab (Eli Lilly) and Lecanemab (Eisai and Biogen), IGC...Read more
LIFT-AD trial did not meet primary endpoint of GST and key secondary endpoints of cognition (ADAS-Cog11) and function (ADCS-ADL23) In pre-specified subgroups of patients with moderate Alzheimer’s disease or who are APOE4 carriers, fosgonimeton showed a numerically greater treatment effect All biomarkers associated with Alzheimer’s disease pathology showed changes with fosgonimeton treatment consistent with the broad...Read more
IGC-1C Targets Tau Protein and GLP-1 Receptor, Offering a Multi-Pathway Approach to Neurodegenerative and Metabolic Disease Treatment POTOMAC, Md. / Aug 22, 2024 / Business Wire / IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") today announced preclinical research demonstrating the therapeutic potential of IGC-1C, a novel small-molecule modulator. The findings show that IGC-1C targets tau protein phase separation,...Read more
PURCHASE, N.Y., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, today announced that results from the SEQUEL study of CT1812, the Company’s lead candidate for the treatment of Alzheimer’s disease, were published in The Journal of Prevention of Alzheimer's Disease. SEQUEL was a single-site study...Read more
In Great Britain, lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers1 Great Britain becomes the first country in Europe to authorize the medicine, which targets an underlying cause of AD1 TOKYO and CAMBRIDGE, Mass., Aug. 22, 2024 /PRNewswire/ -- Eisai Co., Ltd....Read more
High bioavailability of INM-901 oral formulation provides similar drug concentration levels in the brain as intraperitoneal (IP) injection Vancouver, British Columbia--(Newsfile Corp. - August 20, 2024) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today confirms...Read more
ROCHESTER, N.Y., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Vaccinex (Nasdaq: VCNX) today provided an update on new clinical findings from its SIGNAL-AD Phase 1b/2 trial of pepinemab antibody in Alzheimer’s disease. Our Company recently announced positive results of the phase 1b/2 study of its lead product, pepinemab, in early stages of Alzheimer’s disease (AD). The purpose of this report is to share additional data related to cognitive effects...Read more
Findings from exploratory analysis of the PEGASUS trial provide preliminary evidence that AMX0035 engages multiple pathological pathways related to neurodegeneration, including tau CAMBRIDGE, Mass. / Aug 12, 2024 / Business Wire / Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of exploratory analyses on cerebrospinal fluid (CSF) biomarkers from participants with Alzheimer’s...Read more
Coya had previously announced that initial topline data from this Investigator Initiated Trial (IIT) may be presented in Summer 2024. The Houston Methodist Research Institute investigators responsible for this IIT will instead be presenting the entire dataset at the CTAD24 peer reviewed medical conference in Madrid, Spain This IIT, a double-blind, placebo-controlled study (funded by the Gates Foundation and Alzheimer’s Association),...Read more
Results affirm expectation of a novel mechanism of action targeting astrocyte activation to delay progression of Alzheimer’s disease from early stage Mild Cognitive Impairment Findings echo previous phase 2 results in Huntington’s disease based on similarities to neuroimmune pathology in Alzheimer’s ROCHESTER, N.Y., July 31, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering...Read more
Fosgonimeton mitigated amyloid-β-induced toxicity, lowered pTau levels and reduced disruption of protein clearance mechanisms that may contribute to pTau pathology Fosgonimeton treatment, alone and in combination with lecanemab, protected cultures of primary neurons from the toxic effects of amyloid-β BOTHELL, Wash., July 31, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical...Read more
51% of No Tau / Low Tau Patients Showed Improved Cognition and Function Over Three Years; Only Lecanemab Has Clinical Data in No Tau / Low Tau Patient Group Clinical Data and Biomarkers Show Alzheimer's Disease Does Not Stop Progressing After Plaque Clearance. Lecanemab's Dual Action Supports Neuronal Function by Clearing Highly Toxic Protofibrils that Continue to Cause Neuronal Injury and Death After Rapid Plaque Clearance Lecanemab...Read more
Results confirm improvements in cognitive function, memory and locomotor activity Achieved statistical significance in certain behavioral assessments Additional molecular analyses ongoing to elucidate INM-901 mechanisms of action Vancouver, British Columbia--(Newsfile Corp. - July 30, 2024) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline of...Read more
The collaboration aims to identify and develop accessible, minimally invasive blood-based biomarkers specific for tau pathology in the brain These tools have the potential to be used to stratify patients or monitor treatment response for a new generation of future therapies impacting tau pathology in Alzheimer’s disease CAMBRIDGE, Mass. and BREA, Calif. and TOKYO, July 30, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB), Beckman...Read more
AAIC Poster Presentation Highlights XPro's™ Significant Effects on a Wide Range of Synaptic Proteins and Pathways BOCA RATON, Fla., July 29, 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 is pleased to be presenting results of a new and advanced...Read more
The Second Oral Therapy Approved This Decade, ZUNVEYL’s Dual MOA Was Designed to Eliminate Drug Absorption in the Gastrointestinal (GI) Tract, Potentially Addressing Certain Tolerability Issues with Leading Alzheimer’s Disease (AD) Medications, Combined with a Long-Term Efficacy Profile ZUNVEYL’s Innovative Approach Targets AD Symptoms Directly, Designed to Provide Patients with Significant Benefits to Cognitive and Global Function and...Read more
Quanterix improves on its best-in-class p-Tau 217 standalone test with new multi-marker approach reducing the number of patients receiving uncertain results BILLERICA, Mass. / Jul 29, 2024 / Business Wire / Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today presented new data at the Alzheimer’s Association International Conference (AAIC), supporting a novel...Read more
NEWTON, Mass., July 29, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) in the brain for the treatment of Alzheimer’s disease (AD), today announced that the first subject has been dosed with a subcutaneous formulation of sabirnetug (ACU193) in a Phase 1 pharmacokinetic (PK) comparison...Read more
Oral, once daily blarcamesine significantly slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events Clinical benefit of blarcamesine consistently observed for both 30 mg and 50 mg treatment groups Benefits of blarcamesine on both amyloid-beta and brain volume, two underlying pathological hallmarks of Alzheimer’s disease EMA submission expected...Read more
Featured Research Session oral presentation highlights findings that show Lomecel-B™ improved cognitive function, quality of life, and brain volume in the treatment of mild Alzheimer’s Disease Study meets its key objectives to advance data supporting favorable benefit/risk profile, support target engagement, and provide additional support for the efficacy profile of Lomecel-B™ Therapeutic potential demonstrated in MRI biomarker...Read more
-INVOKE-2 is the first global Phase 2 trial evaluating the safety and efficacy of a TREM2 agonist, AL002, in slowing disease progression in individuals with early Alzheimer’s disease (AD) -Baseline characteristics data for the INVOKE-2 study confirm a representative study population that enables testing of the effects of a novel TREM2 agonist in early AD SOUTH SAN FRANCISCO, Calif., July 28, 2024 (GLOBE NEWSWIRE) -- Alector,...Read more
NEWTON, Mass., July 28, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced new findings from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193). The research highlights the experiences of patients in the clinical trial to...Read more
Topline results demonstrated a favorable safety profile and tolerability across four ascending dose levels in healthy volunteers and showed dose dependent levels of PMN310 antibody in Cerebrospinal fluid (CSF) suggestive of its potential for target engagement in Alzheimer’s disease patients CAMBRIDGE, Massachusetts and TORONTO, Ontario, July 26, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a biotechnology...Read more
TOKYO and CAMBRIDGE, Mass., July 26, 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 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Approval...Read more
Treatment of first randomized person with preclinical AD expected this quarter Phase 2b ReTain trial is fully funded and conducted by development partner Lausanne, Switzerland, July 25, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that its active-immunotherapy candidate, ACI-35.030 (now called JNJ-2056), targeting the...Read more
Safety, tolerability, pharmacokinetic and pharmacodynamic profile of VG-3927 supports continued development as potential once-daily oral therapy for Alzheimer’s disease (AD) VG-3927 achieved robust decrease of sTREM2 in CSF demonstrating clinical proof-of-target engagement New preclinical and clinical data from SAD cohorts to be presented at upcoming 2024 Alzheimer’s Association International Conference (AAIC) Company...Read more
Treatment of pre-clinical subjects showed cognitive benefits that suggest HT-ALZ's mode of action may involve a reduction in brain inflammation, thereby improving cognitive outcomes for Alzheimer's patients. HT-ALZ's pre-clinical significance lies in its ability to demonstrate marked cognitive improvement and quality of life for subjects suffering from Alzheimer's disease The pre-clinical research shows compelling evidence of HT-ALZ's...Read more
FDA designation enables expedited clinical development and regulatory review timelines for Lomecel-B™ Second designation received for Lomecel-B™ for the treatment of mild Alzheimer’s Disease after Regenerative Medicine Advanced Therapeutics (RMAT) Designation announced on July 9, 2024 Phase 2a Lomecel-B™ data in mild Alzheimer’s Disease selected for Featured Research Session oral presentation and poster...Read more
ROCHESTER, N.Y., July 17, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease (AD) and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced that it will present topline data for its randomized, double-blind, phase 1b/2 SIGNAL-AD study of pepinemab treatment for Alzheimer’s disease at the Alzheimer’s...Read more
Agreement enhances Company’s intellectual property portfolio SARASOTA, FL, July 16, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced that it has entered into an exclusive global license agreement to further...Read more
BEDFORD, Mass., July 15, 2024 (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 its acquisition of Meilleur Technologies, Inc., which includes NAV-4694, expanding Lantheus’ Alzheimer’s disease pipeline. Through this acquisition, Lantheus now has...Read more
MIAMI, July 10, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for certain life-threatening and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B™ for the treatment of mild Alzheimer’s Disease....Read more
Reporting of Topline Results Targeted by End of Third Quarter 2024 Results to be presented in oral presentation at Clinical Trials on Alzheimer’s Disease (CTAD) on October 29, 2024, in Madrid, Spain BOTHELL, Wash., July 09, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today...Read more
MONTREAL, July 03, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (the “Company” or “IntelGenx” a subsidiary of IntelGenx Technologies Corp.) (OTCQB: IGXT; TSX: IGX), has successfully completed the BUENA Alzheimer’s disease (AD) study. The BUENA study was designed as a Phase 2a proof of concept study to investigate the extent to which different doses of Montelukast (MTK) could improve cognition in adults with AD as well as to provide...Read more
Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk of progressing to the next clinical stage of disease by up to 39% Kisunla is the first and only amyloid plaque-targeting therapy that used a limited-duration treatment regimen based on amyloid plaque removal; nearly half of study participants completed their course of treatment...Read more
PURCHASE, N.Y., July 02, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, today announced that abstracts summarizing clinical efficacy, safety and biomarker findings from the Phase 2 COG0201 “SHINE” study of CT1812 have been accepted for poster presentation at the upcoming Alzheimer’s Association’s...Read more
TOKYO and CAMBRIDGE, Mass., June 27, 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 that the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name in China: “乐意保®”, generic name: lecanemab) has been launched in China....Read more
The planned interim analysis confirms the accuracy of the sample size calculations and statistical power for EMACC, the primary endpoint. The interim analysis, performed by a third-party, demonstrated no need to change trial design or size. BOCA RATON, Fla., June 27, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness...Read more
NEW YORK, June 26, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer’s disease. Expanded access...Read more
Portable ultra-low-field MR brain imaging provides affordable and accessible technology that may help physicians monitor ARIA and Alzheimer's disease progression in diverse professional care settings. GUILFORD, Conn. / Jun 25, 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...Read more
HOUSTON, TEXAS, June 20, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) today announced that the United States Patent and Trademark Office (USPTO) has awarded U.S. Patent No 12,011,591 relating to the Company’s non-invasive Deep Intracranial Frequency Stimulation (DIFS®) medical device for the treatment of Alzheimer’s and other dementia-related brain diseases. The newly issued...Read more
NMRA-511 is a highly potent and selective, best-in-class, antagonist of the vasopressin 1a receptor, which is known to play a role in regulation of aggression, stress and anxiety response NMRA-511 was generally well-tolerated at all dose levels in Phase 1 single ascending dose / multiple ascending dose study, with no serious adverse events reported to date Alzheimer’s disease agitation is associated with increased morbidity and...Read more
TOKYO and CAMBRIDGE, Mass., June 9, 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 U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®)...Read more
Company expects to lock database in June and remains on track to report key outcomes later in July. Pepinemab targets astrocyte reactivity and neuroinflammation, believed to be key drivers of neurodegeneration. ROCHESTER, N.Y., June 06, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the...Read more
This investigator-initiated, double-blind, placebo-controlled study (funded by the Gates Foundation and Alzheimer’s Association) evaluates the safety and tolerability, biological activity, and preliminary efficacy of LD IL-2 in 38 patients with mild-to-moderate Alzheimer’s disease (AD) over 30 weeks Previously reported data from an open-label, proof-of-concept study in eight AD patients illustrated that treatment with LD IL-2 resulted in...Read more
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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