Key Highlights

  • Net loss was $73.6 million, or $1.08 per share, compared with $38.3 million, or $0.65 per share, a year earlier.
  • Revenue was $11.3 million, up from $10.6 million in the third quarter of 2025.
  • Research and development expenses rose to $59.8 million from $37.7 million.
  • Cash, cash equivalents and marketable securities totaled $358.8 million at September 30, 2026.
  • The Phase 3 EMPEROR data readout is anticipated in the third quarter of 2027.

A larger loss as zorevunersen spending ramps

Stoke Therapeutics (NASDAQ:STOK), a Bedford, Massachusetts biotechnology company that uses RNA medicine to restore protein expression, reported third quarter 2026 results on October 29, 2026. Its lead investigational medicine, zorevunersen, is in development as a first-in-class potential disease-modifying treatment for Dravet syndrome, a severe genetic epilepsy.

Net loss was $73.6 million, or $1.08 per share, including $11.0 million of non-cash stock-based compensation. That compares with a loss of $38.3 million, or $0.65 per share, in the same period of 2025, which is an increase of about 92% on a calculated basis.

Where the extra spending went

Research and development expenses were $59.8 million, against $37.7 million a year earlier, driven by increased activities and personnel expenses to support zorevunersen. Sales, general and administrative expenses rose to $28.7 million from $16.0 million on growth in personnel and launch readiness expenses.

On a calculated basis, R&D grew about 59% and SG&A about 79%. Revenue of $11.3 million, up from $10.6 million, comes from contractual obligations under collaboration and licensing agreements with two partners.

Nine-month comparison is distorted by a prior year license

For the nine months ended September 30, 2026, revenue was $26.8 million, compared with $183.0 million a year earlier. The drop was primarily due to $150.8 million recognized in 2025 for the Biogen (NASDAQ:BIIB) intellectual property license performance obligation.

As a result the company posted a nine month net loss of $185.3 million, or $2.81 per share, versus Net Income of $51.0 million, or $0.85 per diluted share, in the prior year period. Nine month R&D was $149.0 million against $96.2 million, and SG&A was $74.0 million against $45.9 million.

EMPEROR progress and an FDA alignment on cognition

Enrollment in the Phase 3 EMPEROR study of zorevunersen is complete, with 162 patients in the primary analysis population from the United States, United Kingdom and Japan. As of October 29, 2026, about 110 patients were through Week 28, when the primary endpoint of change in major motor seizure frequency is measured, and about 20 were through Week 52. No patients have discontinued treatment.

After a meeting with the U.S. Food and Drug Administration, the company plans to assess cognition and behavior, a key secondary endpoint, using a multicomponent assessment of four Vineland-3 subdomains: expressive communication, receptive communication, interpersonal relationships and personal skills. The data readout is anticipated in the third quarter of 2027, with the planned U.S. NDA submission in the second half of 2027.

STK-002 and a cash runway into early 2028

The second program, STK-002, targets autosomal dominant optic atrophy, an inherited optic nerve disorder. In the Phase 1 OSPREY study, dosing of the first two cohorts is complete and the third is underway, with initial safety and efficacy data anticipated in the first half of 2027.

Cash, cash equivalents and marketable securities were $358.8 million at September 30, 2026, which the company expects to fund operations into early 2028. The items to watch are the 2027 readout, the NDA timetable and the pace of spending as launch preparations grow.