Traveling Advance Gene Therapy for Parkinson's Disease, Phase 2 Data May Be Sufficient for Marketing Application in the United States – Voyager Therapeutics (NASDAQ: VYGR)

Based on FDA comments, Voyager Therapeutics (NASDAQ: VYGR) says it is maintaining its plan to submit a BLA seeking approval for VY-AADC gene therapy based on live data 2. He says that he will include the results of Phase 3 only if the mid-stage study fails.

Also, preliminary data from a Phase 1 posterior trajectory trial that demonstrate improved putamen coverage (round structure at the base of the forebrain), reduction in surgical times and improvement in the motor function of the patients in the 6th month was in agreement with the improvements observed in his phase 1b trial. Therefore, the posterior approach will continue to be the preferred VY-AADC surgical route of administration. The dose concentration for pivotal studies will be the same as for cohorts 2 and 3 of the Phase 1b study.