Voyager to assess alternate payloads for SOD1 ALS gene therapy program

Voyager Therapeutics (VYGR) has decided to assess alternate payloads related to its gene therapy program for superoxide dismutase 1 amyotrophic lateral sclerosis. Emerging three-month non-human primate data suggest that an alternate payload would be necessary to achieve the desired product profile. No changes are planned to the novel capsid component. The same capsid in the VY1706 gene therapy program achieved desired activity levels and was well-tolerated in three-month NHP studies. Voyager no longer anticipates filing an investigational new drug application for VY9323 in mid-2025. Voyager’s cash runway is now expected to extend into mid-2027; this does not include any potential milestone payments from existing partnerships. The VY9323 U.S. IND application and Canadian clinical trial application filings had previously been expected to occur in mid-2025. Given the need to assess potential alternate payloads, Voyager will provide an update on expected timing for its SOD1 ALS program when appropriate. The decision on the SOD1 ALS program does not impact Voyager’s other gene therapy programs; the Company continues to expect IND filings in 2025 from Neurocrine Biosciences for the program in GBA1 Parkinson’s and other GBA1-mediated diseases, as well as the program in Friedreich’s ataxia. Voyager also continues to expect to file an IND in 2026 for VY1706.