Stoke Therapeutics Expects Q3 2027 EMPEROR Readout and NDA Filing
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Stoke Therapeutics, Inc. expects to report results from its EMPEROR study in the third quarter of 2027 and complete a New Drug Application (NDA) submission in the second half of the year, setting out the next steps toward a potential U.S. approval in early 2028. The company plans to submit data throughout the first half of 2027. It also completed a meeting with the Food and Drug Administration to align on its NDA plans. The FDA was willing to accept a multicomponent Vineland-3 assessment for the key secondary endpoint, with no hierarchy required.
Source: TokenPost
