Xenon Reports Q3 Results; Expects X-NOVA2 Data In December And Advances Pain Programs Toward Phase 2

Xenon Pharmaceuticals (XENE) reported Q3 2026 progress, including FDA NDA submission for AZK, its epilepsy drug candidate. AZK showed significant efficacy in reducing seizure frequency and a strong safety profile. The company also announced plans for a Phase IIIb/IV study (X-FIRST) and progress in its psychiatry and pain programs, including XEN1701 and XEN1120. Enrollment in the Phase III X-NOVA2 study for MDD was completed, with data expected in December 2026.

Xenon Pharmaceuticals (XENE) reported $1.2B in cash reserves, funding operations into 2029. CEO Ian Mortimer discussed azetukalner's (AZK) potential in epilepsy and psychiatry, noting X-NOVA2 data due in December 2026. XEN1701's development was addressed, with the company confident in its design and safety profile. X-FIRST study plans were outlined, targeting earlier-line patients and general neurologists. Dose selection and FDA feedback were also discussed.

Xenon Pharmaceuticals reported Q3 updates, highlighting its epilepsy drug AZK's success in clinical trials, with a 42.7% median reduction in seizures. The company plans to start a phase IIIb/IV study in 2027 and is preparing for commercial launch. Xenon also expects to initiate phase II studies for pain candidates XEN1701 and XEN1120 in early 2027. With $1.2 billion in cash, the company's runway extends into 2029.

Xenon Pharmaceuticals (XENE) stock fell 2.4% in after-hours trading to $39.50 after reporting Q3 2026 results. The company posted a net loss of $110.4M, beating estimates but widening from the prior year. Revenue missed forecasts. R&D expenses rose due to late-stage programs. The stock was pressured by a voluntary pause in depression trials. The company submitted a New Drug Application for azetukalner and reported a $1.15B cash position.

Xenon Pharmaceuticals Inc. (XENE) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Xenon Reports Q3 2026 Financial Results and Provides Business Update • New Drug Application for azetukalner in focal seizures submitted to U.S. Food & Drug Administration in September 2026 • Expanding potential opportunity in epilepsy through ongoing Phase 3 X-TOLE3

Xenon Pharmaceuticals reported positive Phase 1 results for XEN1701 and XEN1120, supporting their advancement to Phase 2 studies in acute pain. XEN1701 achieved target NaV1.7 receptor occupancy and was well-tolerated. XEN1120 demonstrated plasma levels predictive of analgesic effects. Phase 2 studies are expected to begin in H1 2027. According to the company, preclinical data showed significant pain reduction in non-human primates.