Stoke Therapeutics Q2 Loss Narrows, Revenue Rises: Biogen and Stoke Therapeutics Dose First Patient in Phase 3 Trial of Zorevunersen for Dravet Syndrome.

Stoke Therapeutics reported a narrowed Q2 loss and rising revenue. The company's CEO, Edward Kaye, stepped down and was replaced by interim CEO Ian F. Smith. Stoke Therapeutics also partnered with Biogen to develop and commercialize a treatment for Dravet Syndrome.

Stoke Therapeutics, a biotechnology company dedicated to restoring protein expression through RNA medicine, reported its second-quarter (Q2) financial results. The company's GAAP earnings per share (EPS) of -$0.40 beat the consensus estimate by -$0.13. Revenue for the quarter reached $13.8 million, up 185.7% year-over-year (YoY), surpassing the consensus estimate by $8.56 million. As of June 30, 2025, the company held $355.0 million in cash, cash equivalents, and marketable securities, sufficient to fund operations until mid-2028 [1].

Following the announcement, Edward Kaye, the company's CEO, stepped down, and Ian F. Smith was appointed as the interim CEO. Mr. Smith stated that the company is well-positioned to continue its progress in developing transformative treatments for rare diseases [1].

In addition to its financial results, Stoke Therapeutics announced a strategic collaboration with Biogen to develop and commercialize zorevunersen, an investigational antisense oligonucleotide, for the treatment of Dravet syndrome. Dravet syndrome is a rare genetic disease characterized by refractory seizures and neurodevelopmental impairments. Zorevunersen has demonstrated potential for disease modification and has been granted orphan drug designation by the FDA and the EMA [2].

The collaboration includes a Phase 3 clinical trial, known as the EMPEROR study, which aims to evaluate the efficacy and safety of zorevunersen compared to sham over a 52-week treatment period. The study is expected to enroll participants across the United States, Japan, United Kingdom, and European Union. The primary endpoint of the study is the change in major motor seizure frequency at week 28, with key secondary endpoints including improvements in behavior and cognition [2].

This collaboration underscores Stoke Therapeutics' commitment to addressing unmet medical needs and its potential to bring forward innovative treatments for rare diseases.

References:
[1] https://seekingalpha.com/news/4484119-stoke-therapeutics-gaap-eps-of-0_40-beats-by-0_13-revenue-of-13_8m-beats-by-8_56m
[2] https://investors.biogen.com/news-releases/news-release-details/biogen-and-stoke-therapeutics-announce-first-patient-dosed-phase