FDA Aligns on Zorevunersen NDA Plan, Stoke Eyes 2028 Launch
STOK sits 26% above its 52-week low of $20.32.
Summary
Stoke Therapeutics completed a successful FDA meeting to align on the planned NDA for zorevunersen in Dravet syndrome. The FDA accepted a multicomponent assessment of four Vineland-3 subdomains for the Phase 3 EMPEROR study, a key secondary endpoint. Stoke plans to submit data through H1 2027, complete the NDA in H2 2027, and potentially launch in early 2028. This follows positive long-term data presented with Biogen in September and the Phase 3 enrollment completion in June. The regulatory clarity de-risks the program and sets a concrete path to approval.
At the time of this announcement, STOK was trading at $25.62 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.7B. The 52-week trading range was $20.32 to $40.22. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.