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NRx Pharmaceuticals (NRXP) investor relations material
NRx Pharmaceuticals Study Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study Update summary2 Dec, 2025
Regulatory and Development Updates
FDA accepted the ANDA for a preservative-free ketamine formulation (KETAFREE), with a review goal date of July 29, 2026.
KETAFREE is the first ketamine formulation without benzethonium chloride, a preservative not recognized as safe by the FDA.
A citizens' petition was filed to remove benzethonium chloride from all ketamine products, supported by a published toxicology report, and is awaiting FDA response.
Application for proprietary product name KETAFREE is under FDA review.
Patent application filed to protect the preservative-free ketamine intellectual property.
Manufacturing and Supply Chain
Three commercial lots of KETAFREE have been manufactured, with a goal of one million doses ready by next July.
Modern blow-fill-seal technology enables scalable production exceeding one million doses per month.
Five years of active pharmaceutical ingredient (API) are available in inventory, with plans to switch to U.S.-manufactured API by 2027.
Manufacturing can be scaled further if market demand increases or if regulatory changes drive higher adoption.
Intended for all currently approved ketamine indications and manufactured in the US.
NRx-101 and TMS Combination Study
NRx-101, a fixed-dose combination of D-cycloserine and lurasidone, is being developed for suicidal bipolar depression and as an adjunct to TMS.
Recent studies show low-dose D-cycloserine with TMS yields 87% clinical response and 72% remission in depression and suicidality.
Real-world data confirm that D-cycloserine more than doubles the antidepressant and anti-suicidal effect of TMS.
NRx-101 is not contraindicated in depression due to the addition of lurasidone, unlike D-cycloserine alone.
Over 25,000 doses of NRx-101 are available for a nationwide expanded access program at no charge to patients.
KETAFREE market share if BZT is removed?
NRX-101: How does it avoid DCS contraindication?
NRX-101 + TMS confirmatory trial design?
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Next NRx Pharmaceuticals earnings date
Q4 202513 Mar, 2026
Next NRx Pharmaceuticals earnings date
Q4 202513 Mar, 2026
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Frequently asked questions
NRx Pharmaceuticals Inc. (NRXP) is a clinical-stage pharmaceutical company focused on developing novel therapeutics for the treatment of central nervous system disorders. The company's portfolio includes ZYESAMI, an investigational drug for COVID-19 related respiratory failure, and oral therapeutics NRX-100 and NRX-101 for the treatment of bipolar depression in patients with acute suicidal behavior/ideation and sub-acute suicidal ideation and behavior. The company is headquartered in Wilmington, Delaware, and its shares are listed on the Nasdaq.
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