BioPharmSignal logoBioPharmSignal

Biotech News

Xenon Announces Azetukalner NDA Submission to FDA for Focal Seizures and Provides Update on Psychiatry Clinical Program

Xenon (XENE)XenonFDA / regulatory

New Drug Application for azetukalner in focal seizures submitted to U.S. Food and Drug Administration; X-TOLE3 and X-ACKT continue to enroll focal seizure and PGTCS patients, respectively Enrollment in X-NOVA2 study in MDD completed with approximately 360 total patients; topline data readout

Related news

XENEXenon2026-08-26 20:01 EST

Xenon to Highlight Phase 3 X-TOLE2 Clinical Data and Rational Polytherapy Potential for Azetukalner at EEC 2026

TEVATeva Pharmaceutical Industries2026-08-19 12:30 EST

U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette Syndrome

XERSXeris Pharmaceuticals2026-09-09 12:30 EST

Xeris Hosts Webinar Detailing Its Comprehensive Development Program for XP-8121, an Investigational, Once-Weekly Subcutaneous Levothyroxine for Hypothyroidism

CLNNClene Inc.2026-08-10 12:00 EST

Clene Announces Biomarker Analyses To Be Included in NDA Submission Supporting ALS Accelerated Approval

PRAXPraxis Precision Medicines2026-06-22 12:00 EST

Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation for Elsunersen for the Treatment of Seizures Associated with SCN2A Developmental and Epileptic Encephalopathy Caused by Gain of Function Variants

AXSMAxsome2026-07-15 11:00 EST

Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy

GANXGain Therapeutics2026-06-29 20:05 EST

Gain Therapeutics Receives FDA Clearance of IND to Advance GT-02287 into Phase 2 Clinical Development for Parkinson’s Disease

XENEXenon2026-08-06 20:01 EST

Xenon Reports Q2 2026 Financial Results and Provides Business Update

ACIUAC Immune2026-08-11 11:00 EST

AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD)

IKTInhibikase Therapeutics2026-07-23 12:00 EST

Inhibikase Therapeutics Announces FDA Orphan Drug Designation Granted to IKT-001 for the Treatment of PAH

View all latest news

Xenon

Ion-Channel Therapeutics Xenon Pharmaceuticals develops medicines that modulate neuronal ion channels. Its pipeline addresses epilepsy, depression and pain through mechanisms intended to control abnormal electrical signaling. Azetukalner Azetukalner is a selective Kv7 potassium-channel opener intended to reduce excessive neuronal firing....

Recent company news

XENEXenon2026-09-17 20:01 EST

Xenon Announces Azetukalner NDA Submission to FDA for Focal Seizures and Provides Update on Psychiatry Clinical Program

XENEXenon2026-09-03 20:01 EST

Xenon to Present at Wells Fargo Healthcare Conference

XENEXenon2026-08-28 20:01 EST

Xenon Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

XENEXenon2026-08-26 20:01 EST

Xenon to Highlight Phase 3 X-TOLE2 Clinical Data and Rational Polytherapy Potential for Azetukalner at EEC 2026

XENEXenon2026-08-06 20:01 EST

Xenon Reports Q2 2026 Financial Results and Provides Business Update

Stock data

Close
57.35 USD
Market cap
5.06B USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States