This section highlights FDA-related milestones and regulatory updates for drugs developed by Voyager Therapeutics (VYGR).
Over the past two years, Voyager Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
VCAP-102 and VY7523. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
VCAP-102 - FDA Regulatory Timeline and Events
VCAP-102 is a drug developed by Voyager Therapeutics for the following indication: ALPL Receptor-Mediated Blood-Brain Barrier Transport of Novel AAV Capsids.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VCAP-102
- Announced Date:
- May 15, 2025
- Indication:
- ALPL Receptor-Mediated Blood-Brain Barrier Transport of Novel AAV Capsids
Announcement
Voyager Therapeutics, announced the first peer-reviewed publication of data demonstrating the ability of alkaline phosphatase (ALPL) to transport a novel AAV capsid across the blood-brain barrier (BBB).
AI Summary
Voyager Therapeutics recently announced the first peer-reviewed publication showing that alkaline phosphatase (ALPL) can transport a novel AAV capsid across the blood-brain barrier (BBB). This breakthrough study, published in Molecular Therapy, highlights that the engineered capsid VCAP-102 demonstrates a 20- to 400-fold increase in gene transfer efficiency compared to AAV9 across various brain regions in both rodents and non-human primates. The data point to ALPL as the primary receptor facilitating this transport, indicating the potential for the approach to translate into human applications. Voyager’s success builds on earlier designs, and the company is now evolving next-generation and stealth capsids that are better at transducing brain cells while avoiding the liver and immune detection. The findings support the company’s broader gene therapy initiatives for treating neurological diseases.
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VY7523 - FDA Regulatory Timeline and Events
VY7523 is a drug developed by Voyager Therapeutics for the following indication: In Alzheimer's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VY7523
- Announced Date:
- March 31, 2025
- Indication:
- In Alzheimer's Disease
Announcement
Voyager Therapeutics, today reported new data from its two preclinical programs targeting tau for the treatment of Alzheimer's disease (AD). Data on tau silencing gene therapy VY1706 and anti-tau antibody VY7523 will be presented at the upcoming 2025 International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2025), taking place April 1-5, 2025, in Vienna.
AI Summary
Voyager Therapeutics has reported promising preclinical findings for its two programs targeting tau in Alzheimer’s disease. In a non-human primate study, a single IV dose of the tau silencing gene therapy VY1706 led to significant, dose-dependent reductions in tau mRNA (44% to 73%) and tau protein (27% to 55%). The treatment showed broad brain distribution, effectively reaching areas such as the hippocampus and frontal cortex, while achieving de-targeting from the liver.
Additionally, preclinical results for the anti-tau antibody VY7523 demonstrated its ability to selectively bind pathological tau tangles in a mouse model, reducing tau spread by focusing on the C-terminal epitope. Voyager plans to present more detailed data on both therapies at AD/PD™ 2025 in Vienna from April 1-5, 2025, and will host a live webcast on April 7, 2025, to recap these key findings.
Read Announcement- Drug:
- VY7523
- Announced Date:
- March 3, 2025
- Indication:
- In Alzheimer's Disease
Announcement
Voyager Therapeutics, announced positive topline data from the Company's single ascending dose (SAD) trial of VY7523, an investigational anti-tau antibody developed to selectively inhibit the spread of pathological tau in Alzheimer's disease (AD).
AI Summary
Voyager Therapeutics announced positive topline data from its single ascending dose (SAD) trial of VY7523, an investigational anti-tau antibody designed to selectively block the spread of pathological tau in Alzheimer’s disease. Administered intravenously to healthy volunteers, VY7523 demonstrated a strong safety and tolerability profile, along with dose‐proportional pharmacokinetics, supporting its potential as a best-in-class therapy. Preclinical data previously showed that the antibody could reduce tau spread by about 70% by targeting a unique C-terminal epitope.
The company has now initiated a multiple ascending dose (MAD) trial in patients with early Alzheimer’s disease. Voyager expects to obtain initial tau PET imaging data from this trial in the second half of 2026, which could further validate the antibody's ability to prevent the progression of pathological tau involvement in Alzheimer’s disease.
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