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
SNK01, a cryopreserved, autologous enhanced natural killer cell therapy, delivered in highest dose to date, demonstrates preliminary clinical benefit without any drug-related adverse events. Company advances SNK01 into Phase 2 in moderate Alzheimer’s disease; first patient enrolled in Phase 2 expected in Q2 2024. SANTA ANA, Calif., May 20, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a...Read more
LEXINGTON, Mass., May 16, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced that the first participants were dosed in a Phase 1a single ascending dose (SAD) trial of VY-TAU01, an investigational anti-tau antibody developed to inhibit the spread of pathological tau in Alzheimer’s disease. The objective of the randomized, double-blind,...Read more
Takeda to receive exclusive option to license global rights to ACI-24.060, a potential first-in-class active immunotherapy designed to delay or slow Alzheimer’s disease progression AC Immune to receive upfront payment of $100 million upon closing and be eligible for an option exercise fee and additional potential milestones of up to approximately $2.1 billion AC Immune to host conference call and webcast today at 8:30 a.m. ET OSAKA,...Read more
CHARLOTTESVILLE, Va., May 08, 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 that the first patient has been dosed with sabirnetug (ACU193) in the ALTITUDE-AD Phase 2 clinical trial designed to evaluate the clinical...Read more
Boca Raton, Florida, April 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, is pleased to share an update on two patients from the Phase 1b trial completed in 2021 who have continued to receive XPro™ for treatment of Alzheimer’s Disease (AD) for more than three...Read more
Significantly higher rate of improvement in ADAS-Cog 11 scores in each treatment dose relative to placebo for patients with mild AD Improvement in cognition measured by ADAS-Cog 11 at three months is 3.3 points as compared to 0.3 for placebo, consistent with our previous Phase II AD/PD and Discover studies Plasma Tau protein levels are reduced, consistent with our previous Phase II biomarker data Based on the findings of this...Read more
In vitro studies with SNK01 have shown a direct ability to phagocytose and digest amyloid and alpha-synuclein proteins while also secreting immunoregulatory cytokines and identifying and eliminating autoreactive T cells that contribute to neuroinflammation. SNK01 autologous NK cell therapy demonstrated a positive effect on improving cerebral spinal fluid (“CSF”) and plasma levels of Tau, amyloid, and alpha-synuclein proteins in...Read more
“Bezisterim” has been approved as the non-proprietary name for NE3107 Data shows how bezisterim may be restoring homeostasis via specific genes associated with dementia, metabolism, and inflammation CARSON CITY, Nev., April 25, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (Nasdaq: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including neurological...Read more
CAMBRIDGE, Mass., April 22, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing novel treatments for severe neurodegenerative diseases announced today a collaboration in Alzheimer's Disease (AD) drug development with Genetika+, a leader in precision medicine for psychiatry and neurology. The multi-phase collaboration, which will commence in NeuroSense's currently ongoing Phase 2 AD...Read more
Company's AD-Detect™ Portfolio Offers AB 42/40 and Other Plasma Biomarker Testing, Alongside Traditional Cerebrospinal Fluid and Genetic Tests, to Provide Robust Offering in Brain Health SECAUCUS, N.J., April 22, 2024 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced the launch of a new blood biomarker test for phosphorylated tau 217, or p-tau217. P-tau217 is a biomarker...Read more
Study will assess the clinical utility and workflow benefits of physicians using images acquired by the Swoop® Portable MR Imaging® system to identify ARIA events in Alzheimer’s patients treated with amyloid-targeting therapy GUILFORD, Conn. / Apr 17, 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...Read more
MIAMI, April 15, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that it has been accepted for a Featured Research Oral Presentation to present the Company’s CLEAR MIND Phase 2a study results. CLEAR-MIND is a Phase 2a randomized clinical trial evaluating Lomecel-BTM in mild Alzheimer’s Disease. In addition to the clinical study results, the...Read more
The Elecsys® pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and Company Once approved, the test will aid healthcare providers in identifying amyloid pathology, a key feature of Alzheimer’s disease Roche and Lilly believe the test could play an important role in improving access to early and accurate Alzheimer’s diagnosis Basel, 11 April 2024 - Roche (SIX: RO, ROG; OTCQX:...Read more
BOTHELL, Wash., April 11, 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 announced the publication of preclinical data supporting the therapeutic potential of fosgonimeton in Alzheimer’s disease. The original research article, “Fosgonimeton Attenuates Amyloid-Beta Toxicity in...Read more
SPC-14 shows cognitive and stress reduction benefits in preclinical models SARASOTA, FL, April 10, 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 exercised its option to license Alzheimer’s...Read more
Company plans to initiate trial following recent meeting with FDA No FDA-approved therapies for acute treatment of AAD are currently available NEW HAVEN, Conn., April 10, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced details regarding the planned design of its...Read more
INM-901 receptor binding studies indicate preferential signaling agonism for CB1/CB2 and impacts the PPAR signaling pathway In Vivo studies demonstrate INM-901 reduces neuroinflammation and improves neuronal function Molecular analysis data further explains previously reported observations in behavioral studies on locomotion, memory and cognition Vancouver, British Columbia--(Newsfile Corp. - April 4, 2024) - InMed...Read more
Lonza to manufacture Acumen’s monoclonal antibody, sabirnetug (ACU193), for clinical development and commercialization, if approved Sabirnetug is the first monoclonal antibody candidate to enter the clinic developed to selectively target toxic soluble amyloid beta oligomers, which evidence indicates are a primary underlying cause of Alzheimer’s disease (AD) Acumen is on track to initiate a Phase 2 clinical trial evaluating sabirnetug...Read more
TOKYO and CAMBRIDGE, Mass., March 31, 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 Eisai submitted to the U.S. Food and Drug Administration (FDA) a Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®)...Read more
Findings suggest the test can reduce the need for PET imaging in some patients with mild cognitive decline to enable therapeutic focus on non-Alzheimer's disease causes, broadening access to quality evaluation and lowering healthcare costs SECAUCUS, N.J., March 26, 2024 /PRNewswire/ -- A blood test that analyzes levels of amyloid proteins by highly sensitive mass spectrometry could help physicians establish that Alzheimer's disease...Read more
SNK01 autologous NK cell therapy demonstrated a positive effect on cerebral spinal fluid (“CSF”) and plasma Tau proteins in Alzheimer’s patients. The additional Phase 1 SNK01 trial data suggest clinical activity regarding cognitive function in patients with advanced Alzheimer’s disease in addition to previously disclosed positive effects on amyloid protein and neuroinflammation biomarkers. SANTA ANA, Calif., March 25, 2024 (GLOBE...Read more
Calgary, Alberta--(Newsfile Corp. - March 25, 2024) - Marvel Biosciences Corp. (TSXV: MRVL) (OTCQB: MBCOF), and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the "Company" or "Marvel"), today reported promising interim results from its acute study on MB-204 conducted by Professor Emmanuel Planel of Laval University, a world expert on Tau pathology. Tau phosphorylation is a process where phosphates attach to a Tau...Read more
Addition of pTau217 test further expands the company's leadership in testing options for Alzheimer's disease to improve patient care BURLINGTON, N.C., March 20, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the launch and immediate availability of its test to identify the presence or absence of phosphorylated tau 217 (pTau217), a pivotal blood...Read more
HT-ALZ emerges as a promising novel solution for combating neuroinflammation and cognitive deficits associated with Alzheimer's Disease. NEW YORK, March 19, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), is pleased to unveil positive pre-clinical research showcasing the potential of HT-ALZ, an innovative Alzheimer's disease therapeutic. Targeting the Substance P/Neurokinin 1 Receptor pathway, HT-ALZ emerges as a...Read more
GAINESVILLE, Fla. / Mar 14, 2024 / Business Wire / Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 11,925,659 titled, “Methods for Treating...Read more
INDIANAPOLIS, March 8, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer's disease. The FDA has informed Lilly it wants to...Read more
Patients with Alzheimer’s Disease show improvement in brainwaves following 4 weeks of XPro™ therapy. Boca Raton, Florida, March 05, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) reports significant improvements in electroencephalography (EEG), a biomarker of...Read more
Data shows reduction of microglia activation and improvement in behavior in rodent models of Alzheimer’s disease (AD) and Parkinson’s disease (PD) Nasal anti-CD3 reduced hemorrhage and edema that occurs with ARIA based on animal studies Neuroinflammation modulation may be synergistic to approved treatments in Alzheimer’s Disease NEW YORK, March 05, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana”...Read more
New data advances understanding of new approaches to treating Alzheimer’s disease Research on disease progression could help inform future clinical trials CAMBRIDGE, Mass., March 04, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced it will present new data from its Alzheimer’s disease (AD) portfolio at the upcoming International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™ 2024), taking place March 5-9 in...Read more
BILLERICA, Mass. / Mar 04, 2024 / Business Wire / Quanterix Corporation (NASDAQ: QTRX), a leading provider of ultra-sensitive research products and high-definition diagnostics, announced today that its Simoa® phospho-Tau 217 (p-Tau 217) blood test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) as an aid in diagnostic evaluation of Alzheimer’s Disease (AD). The FDA’s Breakthrough Device...Read more
TORONTO / Feb 29, 2024 / Business Wire / Biomind Labs Inc. (“Biomind” or the “Company”) (NEO: BMND) (OTC: BMNDF) (FSE: 3XI), a leading biotech company focused on developing the next generation of pharmaceuticals to treat patients suffering from neurological disorders by targeting the drivers of disease, today announced the successful conclusion of the Phase 2 clinical trial of its proprietary 5-Metoxi-N,N-dimethyltryptamine...Read more
AdventHealth, Mass General Brigham, Mayo Clinic, MUSC, and UPMC will leverage Quanterix technology and assays to streamline care for Alzheimer’s patients BILLERICA, Mass. / Feb 26, 2024 / Business Wire / Quanterix Corporation (NASDAQ: QTRX), a leading provider of ultra-sensitive research products and high-definition diagnostics, today announced its first collaborations with health systems in pursuit of their shared goal to improve and...Read more
Oral presentation to explore drug effect of sabirnetug (ACU193) on key cerebrospinal fluid biomarkers in early AD Poster presentation to showcase method used to develop a first-of-its-kind assay to measure target engagement of an AβO-selective antibody On track to initiate a Phase 2 trial evaluating sabirnetug in the first half of 2024 Sabirnetug is the nonproprietary name for ACU193 now accepted by the United States Adopted Name...Read more
Additional new data demonstrate VY-TAU01, Voyager’s lead antibody targeting pathological tau, was well-tolerated and demonstrated favorable pharmacokinetics in non-human primates (NHPs) Data to be presented at the 2024 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD™ 2024) LEXINGTON, Mass., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq:...Read more
CAPE CANAVERAL, Fla., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of medicines, today announced it will present clinical data from its UB-312 program in Parkinson’s disease and preclinical data from its anti-tau program in Alzheimer’s disease at the International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD 2024),...Read more
VANCOUVER, British Columbia / Feb 12, 2024 / Business Wire / Alpha Cognition Inc. (CSE: ACOG) (OTCQB: ACOGF), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders provides a business update on it’s ALPHA-1062 NDA filing for U.S. approval of mild-to-moderate Alzheimer’s disease, commercialization strategy, and a pipeline update. The Company completed a transformational year as we began the...Read more
SOUTH SAN FRANCISCO, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC) and GSK plc (LSE/NYSE: GSK) today announced that the first patient has been dosed in PROGRESS-AD, the global Phase 2 clinical trial of AL101/GSK4527226 in patients with early Alzheimer’s disease (AD), including mild cognitive impairment and mild dementia due to AD. AL101 is an investigational human monoclonal antibody designed to block and...Read more
ADAS-Cog Scores Were Stable in a Group of Patients with Mild Alzheimer’s Who Received Drug Candidate Simufilam Continuously, Baseline to Month 24. Mild Alzheimer’s Patients Who Received Simufilam Non-Continuously Declined a Group Average of 1 Point on ADAS-Cog, Baseline to Month 24. Oral Simufilam Safe, Well-Tolerated. AUSTIN, Texas, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company,...Read more
NEW YORK, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that collaborators at the University of Edinburgh, Scotland published findings in the journal, Acta Neuropathologica, (doi: 10.1007/s00401-023-02679-6) that provide new insight into the biology of Alzheimer’s disease that is consistent with our understanding of...Read more
Company to reprioritize resources allocated to ADUHELM® (aducanumab-avwa) to advance LEQEMBI® (lecanemab-irmb) and to develop new treatment modalities Biogen committed to building a leading Alzheimer’s disease franchise to address patient needs CAMBRIDGE, Mass., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced plans to reprioritize its resources in Alzheimer’s disease (AD), a strategic therapeutic area...Read more
The Phase II clinical trial in patients with Alzheimer’s disease with neuroinflammation is on track to complete enrollment mid-2024 with top line data expected approximately six months after the final patient is enrolled. BOCA RATON, Florida, Jan. 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc.(NASDAQ: INMB) (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a...Read more
Preclinical study shows SPC-14’s effectiveness against LH (luteinizing hormone) stress, helplessness, and anxiety. SARASOTA, FL, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company”), a biopharmaceutical company developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced that its Alzheimer’s disease therapeutic SPC-14...Read more
Research demonstrated that activation of the inflammasome/ASC speck pathway has a vital role in synaptic degeneration in Alzheimer’s Disease (AD). ZyVersa is developing IC 100, a monoclonal antibody targeting inflammasome ASC specks to block initiation and perpetuation of damaging inflammation in the central nervous system and peripheral tissues. WESTON, Fla., Jan. 24, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq:...Read more
NEW YORK, Jan. 24, 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 neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, today announced a peer-reviewed publication in Clinical...Read more
Calgary, Alberta--(Newsfile Corp. - January 8, 2024) - Marvel Biosciences Corp. (TSXV: MRVL) (OTCQB: MBCOF) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the "Company" or "Marvel"), is pleased to announce a collaboration with Professor Emmanuel Planel of Laval University to study the acute effect of MB-204 on Tau protein phosphorylation in mice. Abnormal tau phosphorylation is a hallmark of...Read more
Updates on PRX012 and PRX123 for treatment of Alzheimer’s disease, and on birtamimab for treatment of AL amyloidosis Remain on track with partnered programs: Bristol Myers Squibb (BMS-986446 for the treatment of Alzheimer’s disease), Roche (Prasinezumab for the treatment of Parkinson’s disease) and Novo Nordisk (NNC6019 for the treatment of ATTR amyloidosis) Prothena remains well financed with cash, cash equivalents, and restricted...Read more
ABATE Phase 1b/2 AD trial of ACI-24.060 completed enrollment of cohorts 1 and 2 and is expected to complete cohort 3 in January; 6-month and 12-month amyloid PET data expected in H1 & H2 2024, respectively ReTain Phase 2b clinical trial of ACI-35.030 in preclinical AD being launched now by partner VacSYn Phase 2 PD trial of ACI-7104.056 completed enrollment of cohort 1 and commenced cohort 2; safety and immunogenicity update...Read more
Topline data from LIFT-AD on track for second half of 2024 Previously reported independent, unblinded interim analysis supports trial continuation and potential clinically meaningful activity of fosgonimeton Potential first-in-class approach focused on HGF modulation for treatment of neurodegenerative diseases BOTHELL, Wash., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage...Read more
NKGen Biotech’s autologous clinical program product candidate, SNK01, demonstrated improvement in neuroinflammation and cognitive function in patients with Alzheimer’s Disease (“AD”) in its Phase 1 dose-escalation safety trial. SNK01 consists of a non-genetically modified NK cell product with enhanced cytotoxicity and activating receptor expression for the treatment of moderate AD. Initial patient in this Phase 1/2a trial received 6...Read more
NKGen’s SNK01 program continues to show positive progress with the FDA IND clearance in October 2023, and now the CTA clearance by Health Canada for a phase 1/2a clinical trial in moderate Alzheimer’s Disease patients Based on data generated from its Phase I dose escalation safety trial, presented at the recent CTAD conference in October 2023, NKGen is optimistic that the Phase 1/2a clinical trial could demonstrate more...Read more
New clinical data showed that Lomecel-B™ improved cognitive function in multiple measures in a dose-response fashion Caregiver ratings documented improved quality of life in Lomecel-B™ treated patients MRI Biomarker study data showed that Lomecel-B™ countered loss of brain volume in multiple areas associated with Alzheimer’s disease, reduced brain neuroinflammation and improved cerebral blood flow Overall results...Read more
NEW YORK, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, announced today that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agreed that oral blarcamesine for Alzheimer’s...Read more
Enrollment in the Company’s Phase II study using XProTM to treat patients with Alzheimer’s Disease with neuroinflammation is accelerating in sites outside the US and the Company is maintaining its timeline to successfully conclude the trial. In the US, the previously identified clinical hold issues have been successfully addressed however the Phase II study remains on clinical hold pending additional information on long-term stability...Read more
AC Immune’s Targeted Anti-pTau Active Immunotherapy for Alzheimer’s Disease Advances into Phase 2b Trial Potentially registration-enabling Phase 2b study (ReTain) will evaluate the effect of ACI-35.030 on cognition and Tau pathology in approximately 500 participants with preclinical Alzheimer’s disease (AD) Anti-pTau active immunotherapy being designed to potentially prevent or reduce cognitive decline could address need of over 315...Read more
VANCOUVER, British Columbia / Dec 07, 2023 / Business Wire / Alpha Cognition Inc. (CSE: ACOG) (OTCQB: ACOGF) (Alpha Cognition “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, is pleased to announce that the U.S. Food and Drug Administration (FDA) has completed its filing review and has accepted the company’s New Drug Application (NDA) for ALPHA-1062, a...Read more
Presenters, including Nobel Laureate in Medicine, to discuss innovative treatments for neurodegeneration Company to feature lead therapeutic's statistically significant benefits, p < 0.007, for severe Alzheimer's disease (AD) patients NEW YORK, Dec. 6, 2023 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing therapeutics for neurodegenerative...Read more
Positive Trending Data from 57 Per-Protocol Patients Suggest NE3107 is Biologically Active and May Have Impact on Cognitive, Functional, and Biomarker Endpoints Sponsor Identified Issues Relating to Significant GCP Violations and Protocol Deviations, Which Allowed for Data from Only a Subset of Enrolled Patients to be Included in the Efficacy Analysis; Sites Suspected of Improprieties Have Been Referred to FDA Due to Exclusions,...Read more
SAN DIEGO / Nov 27, 2023 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the initiation of a Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis (ADP). Of the more than 6.5 million people in the United States living with Alzheimer’s disease (AD), approximately 30% will experience psychosis, commonly consisting...Read more
Boca Raton, Florida, Nov. 27, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company dedicated to advancing treatments that leverage the patient’s innate immune system to combat disease, announced today it has received European Medicines Agency’s (EMA) Authorized Decision from the Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) in France and the Agencia...Read more
NEW YORK, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders announced today that representatives of Anavex met with team members of the European Medicines Agency (EMA). These meetings discussed the debilitating pathology of...Read more
TORONTO, Ontario and CAMBRIDGE, Massachusetts, Nov. 20, 2023 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced that the Company dosed the first subjects...Read more
The Company received a cash refund of approximately $2.8M USD pursuant to an Australian Research and Development Tax Incentive. Boca Raton, Florida, Nov. 15, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company dedicated to advancing treatments that leverage the patient’s innate immune system to combat disease, has received acceptance of a Clinical Trial Application...Read more
BOTHELL, Wash., Nov. 15, 2023 (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, presented new preclinical data supporting the potential therapeutic benefit of fosgonimeton for the treatment of Alzheimer’s disease (AD) and other neurodegenerative diseases at the Society for Neuroscience (SfN)...Read more
Phase IIa trial outcome indicates the potential for a new way to help Alzheimer’s patients’ agitation Tel-Aviv, Nov. 15, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (NASDAQ: SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (the “Company” or “SciSparc”), unveiled positive topline results from its investigator-initiated Phase IIa trial at the...Read more
NEW YORK, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX) is presenting in vivo preclinical results at the Society for Neuroscience’s annual meeting illuminating the role of sigma-2 (σ-2) receptor modulators, including CT1812, in models of Alzheimer's and Parkinson’s diseases. The effect of two chemically distinct σ-2 receptor modulators in a mouse model of Alzheimer’s disease on gene and protein expression...Read more
Strategic partnership includes co-development of patient-derived xenograft (PDX) Digital Twins for in vivo oncology research Charles River to make an equity investment in Aitia as part of the agreement WILMINGTON, Mass. and SOMERVILLE, Mass., Nov. 13, 2023 /PRNewswire/ -- Charles River Laboratories International, Inc. (NYSE: CRL) and Aitia, a leader in the application of Causal AI and Digital Twins, today announced a...Read more
Alzamend’s recently completed Phase IIA Study of AL001 in Alzheimer’s patients and healthy subjects showed a benign safety profile and identified a candidate dose that is unlikely to require therapeutic drug monitoring Safety aspects of AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval ATLANTA / Nov 13, 2023 / Business Wire / Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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