AXGT - Axovant sees delayed enrollment in Parkinson's study with gene therapy

Axovant Gene Therapies (AXGT) tanks 41% after hours, in reaction to delays in manufacturing process that will potentially postpone the start of enrollment in AXO-Lenti-PD trial, and it seems unlikely to enroll patients by the end of calendar year 2021.The Company expects to provide an update on program timelines in Q1 of 2021 or as program timelines are clarified.Based on new information from its manufacturing partner, Oxford Biomedica, regarding delays in CMC data and third-party fill/finish issues, the development of a suspension-based manufacturing process for AXO-Lenti-PD will take longer than expected.Additionally, Axovant announced patient-level data in cohort 2 of SUNRISE-PD study, demonstrating consistent, clinically meaningful outcomes and evidence of dose response. Showed improvement in Hauser diary “Good ON time” and “OFF time” changes from baseline for all 4 patients. Reduction in Levodopa-equivalent daily dose from baseline.R&D Day webcast will be held tomorrow at 11:30 AM EST.AXO-Lenti-PD is a gene therapy for Parkinson’s disease ((PD)).

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Axovant sees delayed enrollment in Parkinson’s study with gene therapy