Stoke Therapeutics, Inc. 8-K

What Happened
Stoke Therapeutics announced on January 11, 2026 (8-K) that it updated timelines for its EMPEROR Phase 3 study of zorevunersen and reported approximately $391.7 million in cash, cash equivalents and marketable securities as of December 31, 2025. The company expects to complete enrollment of 150 patients in Q2 2026, with a data readout in mid‑2027 and plans to initiate a rolling NDA submission in the first half of 2027. Stoke also held a multidisciplinary meeting with the FDA to discuss development and potential expedited pathways; no immediate program changes were agreed and the FDA requested additional information.

Key Details

• ~$391.7 million in cash, cash equivalents and marketable securities as of Dec 31, 2025 (preliminary, unaudited estimate).
• Expected enrollment complete: 150 patients in Q2 2026; Phase 3 data readout: mid‑2027.
• Plans to begin rolling NDA submission in H1 2027; data readout anticipated to support an NDA to the FDA.
• FDA meeting held; discussions on expedited pathways are ongoing but no immediate changes to the program were agreed.

Why It Matters
For investors, the filing provides a clear timeline for key clinical and regulatory milestones (enrollment completion, mid‑2027 readout, rolling NDA in H1 2027) that could materially affect Stoke’s valuation if results are positive. The company’s reported cash balance, combined with expected eligible Biogen collaboration proceeds, is presented as sufficient to fund operations into 2028—important for assessing near‑term financing needs. Note the cash figure is preliminary and subject to audit and closing adjustments, so final audited results may differ.