Add as a preferred source on GoogleStoke Therapeutics Expects Q3 2027 EMPEROR Readout and NDA Filing
About 110 of 162 enrolled patients had completed a week 28 visit. Stoke ended September with $358.8 million in cash and expects available funds, Biogen reimbursements and a potential milestone payment to support opera…
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.
About 110 of the 162 patients enrolled in EMPEROR had completed a week 28 visit. Stoke ended the quarter on Sept. 30, 2026, with $358.8 million in cash, cash equivalents and marketable securities. It expects that balance to fund operations into early 2028.
Stoke anticipates an EMPEROR results readout in the third quarter of 2027, with its planned NDA submission to follow in the second half of the year.
John Kim
John Kim reports on the digital-asset business for TokenPost. Send corrections or tips to info@tokenpost.com.