On Wednesday, Cantor Fitzgerald reiterated an Overweight rating on Stoke Therapeutics (NASDAQ:STOK), following the company's announcement of a finalized Phase 3 EMPEROR study design for zorevunersen (STK-001), aimed at treating Dravet syndrome (DS).
The study design received regulatory alignment with the FDA, EMA, and PMDA, signaling a potential for differentiated clinical value in DS. Despite Stoke Therapeutics' shares falling approximately 15% recently, Cantor Fitzgerald perceives this as a market inefficiency and an opportunity for investors with a long-term horizon.
The EMPEROR Phase 3 trial is a single global study that has been informed by previous data and is designed to demonstrate differentiation in DS treatment, on top of the best standard of care anti-seizure medication (ASM). The trial includes a 52-week blind period to preserve the integrity of the results for both primary and secondary endpoints. Cantor Fitzgerald notes the trial design simplifies some aspects, such as reducing the number of loading doses and maintaining a single study instead of multiple parallel studies, which could facilitate rapid enrollment and potential partnerships.
Cantor Fitzgerald highlighted the strategic planning behind the EMPEROR trial, emphasizing the potential for the study to establish zorevunersen as a new standard of care in young patients, with the possibility of near-gene-therapy-like pricing and pharmacoeconomic value. The firm suggests that the trial's design reduces risk and may accelerate patient enrollment and partnering opportunities.
Stoke Therapeutics reported having approximately $269 million on its balance sheet, which Cantor Fitzgerald believes positions the company well to fund the EMPEROR trial. The firm anticipates that Stoke will reach enrollment milestones and possibly complete the trial in 2026, viewing the current dip in stock price as a buying opportunity for long-term investors.
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