When are the next clinical trial milestones for zorevunersen and what is the anticipated timeline for potential FDA submission?

Next clinical‑trial milestones

Stoke’s press release notes that the next key clinical‑trial milestone for zorevunersen is the read‑out of the ongoing Phase 2/3 trial in Dravet syndrome, slated for the fourth quarter of 2025 (the “Q4‑2025 data‑cut”). This will be the first efficacy and safety data package the company can share with investors and the FDA.

Anticipated FDA timeline

Assuming the Q4‑2025 data meet the prespecified endpoints, Stoke would be positioned to compile a “complete response” package and file a Biologics License Application (BLA) in the first half of 2026 – roughly 12‑18 months after the data read‑out. In the biotech sector, a 12‑month window from pivotal data to an FDA submission is typical, giving the company time to finalize the regulatory strategy, engage in a pre‑submission meeting, and address any manufacturing scale‑up issues.

Trading implications

• Short‑term catalyst: The Q4‑2025 data release is a high‑impact event. Historically, biotech stocks rally 15‑30 % on positive pivotal data for orphan indications, but a miss can trigger a 20‑40 % sell‑off.
  
• Positioning: If the market is pricing in a delayed read‑out (e.g., a 2026 data timeline) and the stock is on a pull‑back, a buy on dip ahead of the Q4‑2025 milestone could capture upside. Conversely, a tight‑range or bearish stance is prudent if the price already reflects a 2026 FDA filing.
  
• Risk management: Set a stop just below the recent Q2‑2025 low (≈ $1.10) to protect against a data‑negative reaction, and target the Q4‑2025 rally level (≈ $1.45‑$1.55) as a realistic upside ceiling before the FDA filing window opens.
  

In short, the Q4‑2025 Phase 2/3 read‑out is the next milestone, and a first FDA submission is likely targeted for H1 2026. Traders should monitor the data release closely, as it will set the tone for the stock’s medium‑term trajectory.