- Voyager Therapeutics (NASDAQ:VYGR) slumps 20% premarket on light volume in apparent reaction to its Q3 report released after the close yesterday that included an update on VY-AADC, its gene therapy candidate for Parkinson's disease (PD).
- The FDA has apparently changed its mind on potential accelerated review based on successful results from a single Phase 2 study. Last month, the company received an addendum to the agency's July Type C meeting responses stating that it now considers the Phase 2 study as "exploratory," meaning that a Phase 3 trial(s) will be needed. The company plans to discuss the issue with the FDA to clarify matters.
- Q3 results: Collaboration revenue: $2.1M; net loss: ($20.3M (NYSE:MMM)).
- In a separate press release, the company announced long-term data on VY-AADC from an open-label, dose-escalating Phase 1b trial. PD patients receiving the two highest doses (Cohorts 3 and 2) experienced average improvements in diary on-time without troublesome dyskinesia (good ON time) of 1.7 hours per day at month 18 and 2.7 hours per day on year , respectively.
- Now read: Verstem up 6% premarket after Q3 report; duvelisib launch underway, 8K in sales in September
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