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Vigil Neuroscience, Inc. (VIGL) is a pioneering biopharmaceutical company dedicated to developing microglia-focused therapeutics. These specialized treatments aim to treat both rare and common neurodegenerative diseases by restoring the vigilance of microglia, the sentinel cells of the brain’s immune system. Vigil Neuroscience leverages modern neuroscience drug development tools to create precision-based therapies that significantly improve the quality of life for patients and their families.
One of the company's key initiatives is the clinical development of iluzanebart, which is currently in a Phase 2 Proof of Concept (PoC) trial named IGNITE. This is the first-ever interventional trial targeting Adult-onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP) patients, marking a critical advancement in the treatment landscape for this rare disease. In addition, the company is working on VG-3927, an orally available small molecule TREM2 agonist designed to treat more common neurodegenerative diseases associated with microglial dysfunction.
Vigil Neuroscience has also made notable strides in community engagement and support. Their comprehensive patient support initiatives include the ALSPAware program, which offers no-cost genetic testing and counseling. This program aims to reduce the barriers to accurate diagnosis and enable better disease management for ALSP patients.
Recent research presented by the company has revealed significant findings on the diagnostic challenges faced by the ALSP community. For instance, a retrospective analysis disclosed that only 24.7 percent of ALSP patients received an accurate initial diagnosis, with many being misdiagnosed with multiple sclerosis (MS) due to similar early symptoms. Vigil Neuroscience's ongoing research aims to provide better diagnostic tools and treatment options, thereby improving the overall patient journey.
Additionally, Vigil Neuroscience has been actively presenting its latest findings and achievements at various conferences. Recent presentations have highlighted the potential of VG-3927 to treat neurodegenerative diseases like Alzheimer's Disease (AD), showcasing its neuroprotective profile and ability to favorably modulate microglia activation.
As Vigil Neuroscience continues to advance its clinical programs and expand its therapeutic pipeline, it remains committed to delivering innovative solutions that address the unmet needs of patients suffering from neurodegenerative diseases.
Vigil Neuroscience (Nasdaq: VIGL) announced the lifting of FDA's partial clinical hold on doses over 20 mg/kg for its lead candidate, VGL101, aimed at treating adult-onset leukoencephalopathy (ALSP). The decision follows favorable data from an ongoing Phase 1 trial. Vigil plans to present interim Phase 2 trial data in the second half of 2023. VGL101 is currently in the IGNITE trial, with initial findings expected for six patients. The FDA has previously awarded Fast Track and Orphan Drug designations to VGL101, highlighting its potential in addressing the unmet medical needs of ALSP, which affects around 10,000 individuals in the U.S.
Vigil Neuroscience (Nasdaq: VIGL) announced that Ivana Magovčević-Liebisch, Ph.D., J.D., its CEO, will participate in a fireside chat at the Stifel 2023 CNS Days virtual conference on March 29, 2023, at 12:00 p.m. ET. Investors can access the live webcast through the 'Events & Presentations' section on the company's website, with an archived replay available for 90 days post-event.
The company focuses on developing treatments for neurodegenerative diseases using microglia. Its lead candidate, VGL101, is in a Phase 2 trial for adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), and it is also exploring treatments for Alzheimer's disease.
Vigil Neuroscience (Nasdaq: VIGL) dosed its first patient in the IGNITE Phase 2 clinical trial for VGL101, targeting adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). In 2022, the company reported significant progress, including interim data from the Phase 1 trial showing VGL101 was safe and well-tolerated, and interim findings from the ILLUMINATE study indicating greater disease progression in symptomatic versus prodromal ALSP patients. Financially, Vigil ended 2022 with cash of $186.6 million, projected to fund operations into Q1 2025. R&D expenses increased to $47.4 million, reflecting clinical trial advancements.
Vigil Neuroscience, Inc. (Nasdaq: VIGL) announced its participation in the 2023 American Academy of Neurology Annual Meeting, showcasing multiple oral and poster presentations on adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). The disease is rare and lacks approved therapies. Presentations will discuss VGL101, Vigil's lead product candidate, currently in a Phase 2 trial, and findings from interim data related to ALSP's clinical characteristics and misdiagnosis issues. ALSP affects approximately 10,000 individuals in the US, highlighting an urgent need for effective treatments.
Vigil Neuroscience (Nasdaq: VIGL), a clinical-stage biotechnology firm, announced that CEO Ivana Magovčević-Liebisch will present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 8:15 a.m. PT / 11:15 a.m. ET. The event will be accessible via live webcast on their website, with an archived replay available for 90 days post-presentation. Vigil focuses on therapies for neurodegenerative diseases, notably through their lead candidate VGL101, which is in a Phase 2 trial for a rare disease known as ALSP.
Vigil Neuroscience, a clinical-stage biotechnology firm, has appointed Dr. David Gray as Chief Scientific Officer, effective February 27, 2023. Dr. Gray brings nearly 20 years of experience in neurological drug development. He replaces Dr. Spyros Papapetropoulos, who will leave on January 4, 2023, to pursue a CEO opportunity but will remain on Vigil's Scientific Advisory Board. The leadership change is expected to enhance the advancement of Vigil’s pipeline, particularly the development of VGL101 for treating neurodegenerative diseases.
Vigil Neuroscience (Nasdaq: VIGL) has initiated its first-ever interventional trial for patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), a rare neurological disease. The Phase 2 IGNITE trial has begun dosing its first patient with VGL101, a monoclonal antibody aimed at treating this condition. Interim results from prior trials indicate that VGL101 is safe and effective in reducing biomarkers associated with ALSP. This study seeks to establish proof of concept by evaluating VGL101's safety, tolerability, and effects on disease progression.
Vigil Neuroscience (Nasdaq: VIGL) will host a Key Opinion Leader (KOL) event on December 6, 2022, in New York City, focusing on adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). The event aims to discuss the disease background, epidemiology, and the Phase 2 trial design for VGL101, the company’s lead product candidate targeting TREM2. The event features expert speakers and will be accessible via a live webcast. Vigil Neuroscience is dedicated to developing treatments for neurodegenerative diseases by restoring microglial function.
Vigil Neuroscience reported promising interim data from its Phase 1 trial of VGL101 in healthy volunteers, demonstrating safety and potential efficacy for treating adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). The company is set to commence a Phase 2 trial this quarter, supported by a Fast Track designation from the FDA. Additionally, Vigil completed a $75 million PIPE financing, enhancing its cash runway to early 2025. The company reported a net loss of $17.5 million for Q3 2022, up from $10.7 million year-over-year due to rising operational costs.
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