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FAQ: NRx Pharmaceuticals Q3 2025 Results and Regulatory Progress for NRX-100 and NRX-101
TL;DR
NRx Pharmaceuticals' regulatory progress with NRX-100 and NRX-101 creates investment advantage through Fast Track status and potential market leadership in suicidal depression treatment.
NRx Pharmaceuticals follows structured regulatory pathways with NDA filings for NRX-100 and NRX-101 supported by real-world evidence and planned phase 3 trials in 2026.
NRx Pharmaceuticals' treatments for suicidal depression and bipolar depression offer hope for improved mental health outcomes and reduced suicide rates worldwide.
NRx Pharmaceuticals discovered that D-cycloserine more than doubles the antidepressant effect of TMS therapy, revealing new possibilities for mental health treatment combinations.
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NRx reported its first revenue-generating activities and significant regulatory progress for NRX-100 and NRX-101, including expanded Fast Track status for NRX-100 in suicidal depression and initiation of NDA filings with Breakthrough Therapy Designation for NRX-101.
NRX-100 is preservative-free intravenous ketamine for treating suicidal depression that has received expanded Fast Track status, has an active Expanded Access program, and is progressing through NDA and ANDA pathways with a Q2 2026 GDUFA date target for its KETAFREE formulation.
NRX-101 is an oral D-cycloserine/lurasidone combination that has Breakthrough Therapy Designation for suicidal bipolar depression, with real-world evidence showing D-cycloserine more than doubles the antidepressant and antisuicidal effect of TMS, and a confirmatory phase 3 trial is planned for early 2026.
NRx focuses on developing therapeutics for central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD using its NMDA platform technology.
The preservative-free ketamine KETAFREE ANDA pathway remains on track for a Q2 2026 GDUFA date, and the FDA communication indicated no major deficiencies in the revised ANDA filing.
Large-scale real-world ketamine data supports the NRX-100 NDA, and real-world evidence for NRX-101 shows that D-cycloserine more than doubles the antidepressant and antisuicidal effect of TMS treatment.
The HOPE delivery platform is NRx's treatment delivery system that continues to expand with additional facilities planned in Florida to support the company's therapeutic programs.
The latest news and updates relating to NRXP are available in the company's newsroom at https://ibn.fm/NRXP, and the full press release can be viewed at https://ibn.fm/XfuD3.
NRX-100 has Fast Track Designation for treatment of Suicidal Ideation in Depression, and NRX-101 has Breakthrough Therapy Designation for treatment of suicidal bipolar depression.
NRx is working to remove benzethonium chloride from commercial ketamine formulations and has developed preservative-free intravenous ketamine (NRX-100) as part of this effort to improve safety and efficacy.
Curated from InvestorBrandNetwork (IBN)
