News Related to Bipolar Depression

NRx reports positive FDA feedback on preservative-free ketamine filings

Apr 22, 2026

NRx said the FDA issued a positive review letter on its preservative-free ketamine ANDA, requesting only minor administrative changes. The company also received FDA guidance outlining a path to an NDA for NRX-100 using clinical trial data and real-world evidence.

Phase III X-TOLE2 data support azetukalner filing in focal onset seizures

Apr 21, 2026

Xenon Pharmaceuticals reported positive Phase III X-TOLE2 results for azetukalner in focal onset seizures. The company plans an FDA new drug application in Q3 2026.

NRx says FDA outlined path for NRX-100 depression drug application

Apr 06, 2026

NRx said the FDA outlined a path for a New Drug Application for NRX-100, a preservative-free ketamine formulation for depression with suicidality. The company plans to submit the NDA by June 2026 and said no additional nonclinical or bridging studies would be required.

Bipolar Depression Pipeline Expands With 10+ Therapies in Development Across 8+ Companies

Mar 12, 2026

The bipolar depression treatment pipeline includes over 10 therapies from 8+ companies, with recent Phase 3 trials initiated for azetukalner and multiple emerging drugs targeting novel pathways expected to launch by 2036.

Xenon Pharmaceuticals to Report Phase 3 Epilepsy Trial Results for Azetukalner

Mar 09, 2026

Xenon Pharmaceuticals will announce topline data from its Phase 3 X-TOLE2 study of azetukalner in patients with focal onset seizures on March 9, 2026, during a conference call at 8:00 a.m. ET.

NRx Pharmaceuticals Completes FDA Meeting on NRX-100 for Suicidal Depression

Feb 28, 2026

NRx Pharmaceuticals completed an in-person FDA Type C meeting regarding NRX-100, a preservative-free ketamine formulation for suicidal depression. The company received guidance on a path to file a New Drug Application based on existing trial data and Real World Evidence from over 65,000 patients.

NRx Pharmaceuticals Charts Path to NDA for NRX-100 Following FDA Guidance

Feb 17, 2026

NRx Pharmaceuticals completed a Type C meeting with the FDA, receiving guidance to file a New Drug Application for NRX-100 based on existing trial data and real-world evidence from over 65,000 patients, with submission planned for Q2 2026.

NRx Pharmaceuticals Receives FDA Guidance on New Drug Application Path for NRX-100

Feb 17, 2026

NRx Pharmaceuticals completed a Type C meeting with FDA leadership and received oral guidance supporting a New Drug Application for NRX-100 (preservative-free ketamine) based on existing trial data and Real World Evidence from over 65,000 patients.