Stoke advances Phase 3 Dravet trial toward mid-2027 data, posts $50M Q1 loss on lower revenue

Filed May 7, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 13, 2025 · ~2 min read

Key Changes

• high

  Phase 3 EMPEROR enrollment nearing completion with final patient randomization expected June 2026; topline data anticipated mid-2027 to support potential late-2027 U.S. commercial launch. Four-year open-label extension data show 93% of eligible patients continued treatment with durable seizure reductions.

  MD&A: Clinical Development verify on EDGAR →
• high

  Q1 2026 net loss of $50M vs. $113M net income in Q1 2025, driven by $152M revenue decline. Prior-year quarter included one-time $151M Biogen upfront payment recognition; current quarter reflects $6M run-rate collaboration revenue. Cash runway shortened from 'mid-2028' to 'into 2028' despite $411M cash balance.

  MD&A: Financial Results verify on EDGAR →
• high

  STK-002 (ADOA) Phase 1 study dosed first patient February 2026, with two patients enrolled as of May 2026. Dose escalation expected through 2026 into early 2027, marking transition from preclinical to clinical stage for second pipeline asset.

  MD&A: Pipeline Expansion verify on EDGAR →