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WATERTOWN, Mass. - Vigil Neuroscience, Inc. (NASDAQ:VIGL), a biotech firm focusing on neurodegenerative diseases with a market capitalization of $369 million, has announced the discontinuation of its Phase 2 IGNITE clinical trial for iluzanebart, a treatment candidate for adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). Despite today’s negative news, InvestingPro data shows the stock has delivered an impressive 365% return year-to-date, though it’s currently trading slightly above its Fair Value. The trial’s termination follows findings that showed iluzanebart did not meet the expected biomarker or clinical efficacy endpoints.
The IGNITE study, an open-label trial, aimed to assess the safety, tolerability, and pharmacokinetics of iluzanebart in patients with ALSP, a rare and severe neurological disorder. Despite the trial’s outcome, Vigil Neuroscience highlighted the drug’s favorable safety and tolerability profile across two dosage cohorts. According to InvestingPro analysis, the company maintains a strong financial position with a healthy current ratio of 2.97 and more cash than debt on its balance sheet, providing runway for continued research and development efforts.
Patients enrolled in the IGNITE trial, all of whom have a confirmed CSF1R gene mutation symptomatic of ALSP, received intravenous infusions of iluzanebart every four weeks for one year. Secondary outcomes of the trial included evaluating the drug’s impact on disease progression biomarkers and standard cognitive, motor, and functional assessments.
In addition to IGNITE, Vigil conducted the ILLUMINATE natural history study to deepen the understanding of ALSP. The company believes that the data collected from both IGNITE and ILLUMINATE have contributed to increased awareness and knowledge about the disease, despite the lack of a positive outcome for iluzanebart.
President and CEO of Vigil Neuroscience, Ivana Magovčević-Liebisch, Ph.D., J.D., expressed gratitude towards the ALSP community for their support and partnership throughout the trial’s duration. She acknowledged the disappointment in the trial’s results but remained proud of the collective efforts and insights gained.
ALSP affects an estimated 19,000 people in the United States and presents similar prevalence in Europe and Japan. Characterized by cognitive dysfunction, neuropsychiatric symptoms, and motor impairment, the disease typically progresses rapidly, with a life expectancy of around six to seven years post-diagnosis. Currently, there are no approved therapies for ALSP.
Vigil Neuroscience continues to develop other treatments for neurodegenerative diseases, including VG-3927, a small molecule TREM2 agonist targeting common conditions such as Alzheimer’s disease.
The decision to halt the IGNITE trial is based on the outlined process and is in line with the company’s commitment to developing precision-based therapies for neurodegenerative diseases. This article is based on a press release statement from Vigil Neuroscience.
In other recent news, Vigil Neuroscience is set to be acquired by Sanofi for approximately $470 million, translating to $8 per share, with the deal expected to close in the third quarter of 2025. This acquisition includes a non-transferable contingent value right (CVR) of $2 per share contingent upon the first commercial sale of VG-3927, Vigil’s investigational treatment for Alzheimer’s disease. Stifel analysts downgraded Vigil Neuroscience from a Buy to a Hold, lowering the price target to $8.00, while Guggenheim and Mizuho also downgraded the stock to Neutral, aligning their price targets with the acquisition terms. Despite these downgrades, Stifel initially maintained a Buy rating with an $11 target before the acquisition announcement. The acquisition’s focus on VG-3927 aligns with Sanofi’s strategy to enhance its neurology pipeline. Additionally, Vigil Neuroscience’s shareholders recently approved board nominees and the ratification of PricewaterhouseCoopers as the independent auditor for 2025. The transaction excludes another Vigil asset, VGL101, which will revert to Amgen, the original licensor. This acquisition reflects the ongoing interest in advancing treatments for Alzheimer’s disease within the biotech sector.
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