WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) reported third-quarter financial results and detailed a rapidly accelerating push into new psychiatric treatments, expanded clinic operations, and a dual-path regulatory strategy aimed at bringing novel and generic ketamine therapies to market.
The company said it has refiled its Abbreviated New Drug Application for KETAFREE, a preservative-free formulation of ketamine, after receiving supportive correspondence from the U.S. Food and Drug Administration. NRx expects a second-quarter 2026 GDUFA date. The filing comes as the generic ketamine market is estimated at roughly $750 million, while branded intranasal alternatives continue to generate more than $1.6 billion in annual revenue.
NRx is also advancing NRX-100, an intravenous ketamine-based treatment for suicidal ideation in major depressive and bipolar depression. The drug received FDA Fast Track designation and is being developed through both an NDA and an ANDA pathway. A New Drug Application is expected to be completed later this year, supported by real-world data from more than 60,000 patients treated with IV ketamine. Early analyses suggest IV ketamine may provide faster and stronger effects than nasal formulations.
The company has additionally applied for a Commissioner’s National Priority Voucher, a new FDA mechanism that could sharply reduce review timelines.
NRX-101, the company’s oral therapy combining D-cycloserine and lurasidone, also advanced its regulatory position. Awarded Breakthrough Therapy Designation, the drug is now in rolling NDA review. Newly published real-world findings indicate its active ingredient may more than double the effectiveness of transcranial magnetic stimulation in depression, suicidality and PTSD. NRx has launched a national expanded-access program and manufactured more than 25,000 treatment-ready doses.
NRx’s delivery network, HOPE Therapeutics, continued its expansion with three revenue-generating interventional psychiatry clinics now operating in Florida and at least three more expected by year’s end. The centers offer neuroplastic drugs, TMS, hyperbaric therapy and digital therapeutics, and recently became the first in Florida to launch a one-day TMS protocol shown to deliver rapid and high rates of remission when combined with D-cycloserine. Additional acquisitions are under discussion.
For the quarter ending Sept. 30, the company reported a $4 million operating loss, compared with a $3 million loss in the same period last year. Increased spending included $800,000 in added research and development costs tied to FDA submissions for NRX-100 and NRX-101, and $400,000 in higher general and administrative expenses, largely related to HOPE clinic operations and acquisition efforts.
NRx ended the quarter with approximately $7.1 million in cash and equivalents, or $10.3 million including a subscription receivable collected in early October. The company recorded revenue for the first time in its history — about $240,000 — reflecting 22 days of operations from the recently acquired Dura Medical clinic group.
Management said it anticipates significant revenue growth in the fourth quarter and throughout 2026 as newly acquired clinics contribute full-period results and additional sites come online. The company said its current capital position should sustain operations at least through the second quarter of 2026 while supporting ongoing regulatory milestones and planned acquisitions.
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