SALT LAKE CITY, June 30, 2025 (GLOBE NEWSWIRE) -- Clene, Inc. (Nasdaq: CLNN) and its subsidiary, Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to advancing therapies for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today provided a regulatory update following a Type C meeting with the U.S. Food and Drug Administration (FDA), and announced two additional meetings scheduled with the FDA in the 3rd quarter of 2025. In th ...

MELBOURNE, Australia and SAN FRANCISCO, June 23, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that David Stamler, M.D., Chief Executive Officer of Alterity, will participate in a Fireside Chat hosted by MST Access on Wednesday, 25 June 2025 in Australia / Tuesday, 24 June 2025 in the United States. Dr. Stamler will provide a co ...

Core Insights - Vigil Neuroscience, Inc. announced an update on the Phase 2 IGNITE clinical trial for iluzanebart, a monoclonal antibody TREM2 agonist, aimed at treating adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) [1][2] Group 1: Clinical Trial Results - Iluzanebart showed a favorable safety, tolerability, and pharmacokinetic profile in both 20 mg/kg and 40 mg/kg dose cohorts [2] - The Phase 2 IGNITE trial did not demonstrate beneficial effects on biomarker or clinical efficacy endpoints for ALSP patients [2] - As a result of these findings, the Phase 2 long-term extension study is being discontinued [2] Group 2: Company Perspective - The CEO of Vigil expressed gratitude towards the ALSP community for their support during the trial process, despite the disappointing data outcome [3] - The company believes that the data collected from the IGNITE trial and the ILLUMINATE natural history study have increased awareness and understanding of ALSP [3] Group 3: Trial Design and Objectives - The IGNITE trial was a global Phase 2, open-label proof-of-concept study involving 20 patients with symptomatic ALSP and a confirmed CSF1R gene mutation [4] - The primary objective was to evaluate the safety and tolerability of iluzanebart, while secondary measures included assessing its effects on target engagement and biomarkers of disease progression [4] - Patients received intravenous infusions of iluzanebart at 20 mg/kg or 40 mg/kg approximately every four weeks for one year [4] Group 4: Disease Background - ALSP is a rare, inherited neurological disease caused by a mutation in the CSF1R gene, affecting an estimated 19,000 people in the U.S. [5] - The disease typically presents in adults in their forties and is characterized by cognitive dysfunction, neuropsychiatric symptoms, and motor impairment, with a life expectancy of approximately six to seven years post-diagnosis [5] - There are currently no approved therapies for ALSP, highlighting a significant unmet medical need [5] Group 5: Company Overview - Vigil Neuroscience focuses on developing treatments for neurodegenerative diseases by restoring the function of microglia, the brain's immune cells [6] - The company is also developing VG-3927, a novel small molecule TREM2 agonist, targeting common neurodegenerative diseases, initially focusing on Alzheimer's disease [6]

Core Viewpoint - Sanofi has entered into a definitive merger agreement to acquire Vigil Neuroscience for an upfront payment of $8.00 per share, with potential additional payments based on the commercial success of VG-3927, valuing the total equity of the transaction at approximately $600 million on a fully diluted basis [1][5][6]. Company Overview - Vigil Neuroscience is a clinical-stage biotechnology company focused on developing treatments for neurodegenerative diseases by restoring the function of microglia, the immune cells of the brain [11]. - The company is developing VG-3927, a small molecule TREM2 agonist aimed at treating Alzheimer's disease, and has a pipeline that includes therapies for both rare and common neurodegenerative diseases [11]. Transaction Details - The merger agreement stipulates that Vigil's shareholders will receive $8.00 per share in cash at closing, plus a contingent value right (CVR) that could yield an additional $2.00 per share upon the first commercial sale of VG-3927 [1][5][6]. - The acquisition is expected to close in the third quarter of 2025, subject to customary conditions including shareholder approval and regulatory clearances [8]. Strategic Rationale - Sanofi's acquisition of Vigil aligns with its strategic focus on neurology and the development of innovative therapies for critical unmet needs in neurodegenerative diseases [4]. - The TREM2 target is seen as a promising area for addressing immune dysregulation and neurodegeneration, particularly in Alzheimer's patients who currently have limited treatment options [4][2]. Development Potential - The acquisition is anticipated to strengthen the development path for VG-3927, which is positioned as a Phase 2-ready clinical candidate for Alzheimer's disease [5][6]. - Activating TREM2 is expected to enhance the neuroprotective function of microglia, potentially preventing neural degeneration associated with adult-onset neurodegenerative diseases [2][3].

Core Viewpoint - Sanofi has announced the acquisition of Vigil Neuroscience, Inc., enhancing its neurology pipeline with a focus on developing treatments for Alzheimer's disease, specifically through the investigational drug VG-3927 [1][5]. Group 1: Acquisition Details - Sanofi will acquire all outstanding common shares of Vigil for $8 per share, totaling an equity value of approximately $470 million on a fully diluted basis [8]. - Vigil's shareholders will also receive a contingent value right (CVR) entitling them to a deferred cash payment of $2 upon the first commercial sale of VG-3927 [8]. - The acquisition is expected to close in Q3 2025, subject to customary conditions including shareholder approval and regulatory clearances [9]. Group 2: Strategic Importance - This acquisition aligns with Sanofi's strategic focus on neurology and aims to address critical unmet needs in Alzheimer's treatment, where current therapies do not halt or reverse disease progression [4][2]. - The acquisition follows a $40 million strategic investment made by Sanofi in Vigil in June 2024, which included rights to negotiate for VG-3927 [5]. Group 3: Scientific Rationale - VG-3927 is an oral small molecule TREM2 agonist, which is expected to enhance the neuroprotective function of microglia in Alzheimer's disease [1]. - Activation of TREM2 is believed to improve microglial response to injury, potentially preventing neural degeneration associated with neurodegenerative diseases [3].

Core Viewpoint - Anavex Life Sciences Corp. is actively participating in two upcoming investor conferences, showcasing its focus on developing innovative treatments for various neurodegenerative and neurodevelopmental disorders, including Alzheimer's and Parkinson's diseases [1][2]. Company Overview - Anavex Life Sciences Corp. is a publicly traded biopharmaceutical company dedicated to developing novel therapeutics for neurodegenerative, neurodevelopmental, and neuropsychiatric disorders [2]. - The company's lead drug candidate, ANAVEX2-73 (blarcamesine), has completed multiple clinical trials for Alzheimer's disease and is also being studied for Parkinson's disease dementia and Rett syndrome [2]. - ANAVEX2-73 is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, with preclinical studies indicating its potential to halt or reverse Alzheimer's disease [2]. - The company is also developing ANAVEX3-71, which targets SIGMAR1 and M1 muscarinic receptors, showing promise in addressing cognitive deficits and other hallmarks of Alzheimer's disease in preclinical trials [2]. Upcoming Events - Anavex's President & CEO, Christopher U. Missling, PhD, will participate in the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, at 2:30 pm ET [1]. - The company will also be present at the H.C. Wainwright 6th Annual Neuro Perspectives Conference on June 17, 2025, at 7:00 pm ET [1].

Data from Phase 1 clinical trial of ATH-1105 in healthy volunteers showed a favorable safety and tolerability profile; dose proportional pharmacokinetics and CNS penetration support continued clinical development On-track to enable initiation of a clinical trial in ALS patients in late 2025 BOTHELL, Wash., May 13, 2025 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a clinical stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, ...

Core Viewpoint - Anavex Life Sciences Corp. is advancing its clinical-stage biopharmaceutical portfolio focused on innovative treatments for neurodegenerative diseases, particularly Alzheimer's disease and schizophrenia, with recent positive developments in clinical trials and financial results for Q2 fiscal 2025 [1][2]. Recent Highlights - The company successfully completed enrollment in its Phase 2 clinical study of ANAVEX®3-71 for schizophrenia, with a total of 71 participants [5]. - Anavex presented open-label-extension data for blarcamesine at the AD/PD™ 2025 conference, confirming its clinical benefits for early Alzheimer's patients [2]. - The appointment of Professor Dr. Audrey Gabelle to the Scientific Advisory Board enhances the company's expertise in Alzheimer's disease [5]. Financial Highlights - Cash and cash equivalents decreased to $115.8 million as of March 31, 2025, from $132.2 million at the end of fiscal 2024, indicating a runway of approximately 4 years at current utilization rates [5]. - General and administrative expenses for Q2 were $2.6 million, down from $2.9 million in the same quarter of fiscal 2024 [5]. - Research and development expenses increased slightly to $9.9 million compared to $9.7 million in the prior year [5]. - The net loss for Q2 was $11.2 million, or $0.13 per share, compared to a net loss of $10.5 million, or $0.13 per share, for the same quarter in fiscal 2024 [5][10].

ATH434 Phase 2 Data to be Presented at Opening Plenary SessionMELBOURNE, Australia and SAN FRANCISCO, May 07, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that multiple oral and poster presentations related to Alterity’s clinical programs in Multiple System Atrophy (MSA) will be featured at the 2025 International MSA Congress t ...

SALT LAKE CITY, May 07, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its first quarter 2025 financial results and provided recent updates on its CNM-Au8 programs. "Prolonging survival for people livi ...