Stoke Therapeutics(STOK) - 2025 Q4 - Annual Results

Clinical Development and Regulatory Pathways - The Company expects to complete enrollment of 150 patients in the second quarter of 2026, with a data readout in mid-2027 anticipated to support the submission of a New Drug Application (NDA) to the FDA[11] - The Company held a multidisciplinary meeting with the FDA to discuss the ongoing clinical development of zorevunersen, exploring potential expedited regulatory pathways, with ongoing discussions for additional information[11] - The Company plans to initiate a rolling NDA submission in the first half of 2027[11] - The Company anticipates that the ongoing EMPEROR study will provide critical data for future product development and regulatory submissions[5] - The Company is focused on advancing zorevunersen to treat Dravet syndrome, with expectations for significant clinical trial results[10] Financial Position and Projections - The Company has approximately $391.7 million in cash, cash equivalents, and marketable securities as of December 31, 2025, which, combined with eligible proceeds from the Biogen collaboration, is expected to fund operations into 2028[11] - The preliminary financial information is subject to completion of financial closing procedures and may differ from actual results in the audited financial statements[6] Strategic Collaborations and Risk Management - The Company is collaborating with Acadia Pharmaceuticals and Biogen International to enhance its development activities and achieve strategic goals[10] - The Company is actively managing risks related to global business conditions, including inflation and geopolitical conflicts, which may impact operations[10] Intellectual Property Strategy - The Company is committed to protecting its intellectual property as part of its overall strategy for product commercialization[10]