XENE — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• We are a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need.

• We remain on track to submit our New Drug Application (NDA) for azetukalner in FOS in the third quarter of 2026, having completed a pre-NDA meeting with the U.S. Food and Drug Administration (FDA).

• The Phase 3 X-TOLE3 study of azetukalner in FOS continues to enroll and is intended to support regulatory submissions outside of the United States. X-TOLE3 enrollment outside of Japan is expected to complete in 2026.

• We recently received approval of our Clinical Trial Application (CTA) to initiate a Phase 1 study of XEN1720 targeting Nav1.7. The Phase 1 SAD/MAD study in healthy adult participants is now underway.

• Beyond azetukalner, we are committed to advancing additional novel treatment approaches to address significant unmet needs in epilepsy.

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• We are a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics. We are advancing an ion channel product portfolio to address areas of high unmet medical need, including epilepsy and depression.

• We announced positive topline data from the Phase 3 X-TOLE2 study in March 2026. The study met its primary endpoint of median percent change (MPC) in monthly FOS frequency from baseline to week 12 in both the 25 mg and 15 mg azetukalner dose groups compared to placebo (MPC of -53.2%, -34.5% and -10.…

• X-TOLE2 topline efficacy and safety results were featured as a Late Breaking Science oral and poster presentation at the American Academy of Neurology (AAN) Annual Meeting in Chicago, Illinois, April 18-22. Also at AAN, we presented 48-month data from the ongoing X-TOLE open-label extension study, w…

• The Phase 3 X-TOLE3 study of azetukalner in FOS continues to enroll and is intended to support regulatory submissions outside the United States. X-TOLE3 enrollment outside of Japan is expected to complete in 2026.

• IND-enabling studies are ongoing for our Nav1.1 program. Pre-clinical data suggest that targeting Nav1.1 could potentially address the underlying cause and symptoms of Dravet syndrome.

Text added vs the prior filing · source: 10-Q · 2026-08-06

• On May 29, 2026, Dr. Christopher Kenney, the Company’s Chief Medical Officer, adopted a trading plan intended to satisfy the requirements of Rule 10b5-1(c) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The plan provides that commencing August 28, 2026, Dr. Kenney may se…

• On June 30, 2026, Andrea DiFabio, the Company’s Chief Legal Officer, adopted a trading plan intended to satisfy the requirements of Rule 10b5-1(c) under the Exchange Act. The plan provides that commencing September 29, 2026, Ms. DiFabio may sell up to an aggregate of 25,402 of the Company’s common s…

• The number of shares to be sold in accordance with each of these trading plans is subject to various minimum price targets, or limit prices, being met on each applicable predetermined sale date. In the event the minimum price targets are not met on the applicable predetermined sale date or on any su…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• During our last fiscal quarter, no director or officer, as defined in Rule 16a-1(f), adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Item 408 of Regulation S-K.