WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) moved closer to potential commercialization of its preservative-free ketamine product in the first quarter as the company scaled manufacturing, advanced multiple FDA filings, and expanded psychiatric treatment operations tied to depression and PTSD therapies.
The company expects an FDA decision in the third quarter on its abbreviated new drug application for KETAFREE, a preservative-free ketamine formulation, after receiving favorable preliminary determinations from the FDA Office of Generic Drugs on bioequivalence, labeling, safety, drug substance, and drug product reviews.
NRx stated it has begun commercial-scale ketamine manufacturing at a rate of roughly one million doses per month following a recent FDA inspection that resulted in a voluntary action indicated, or VAI, classification consistent with continued regulatory review.
Sterile intravenous ketamine remained on the American Society of Health-System Pharmacists national drug shortage database as of April, according to the company, as supply constraints persisted across multiple manufacturers.
Chief Executive Officer Jonathan Javitt described the quarter as “pivotal” as NRx advanced “two lifesaving drugs towards FDA approval with the aim of initiating commercial pharmaceutical operations by the end of this year.”
The company also disclosed progress on NRX-101, a combination therapy of D-cycloserine and lurasidone being developed for suicidal bipolar depression and as an adjunct to robotic-assisted transcranial magnetic stimulation, or TMS.
NRx said the FDA accepted an investigational new drug application for the MIND1 trial, a Phase 2b/3 study evaluating NRX-101 alongside accelerated one-day TMS protocols. The study is expected to enroll 400 participants across military treatment facilities, university sites, and clinics operated by HOPE Therapeutics, the company’s psychiatry subsidiary.
Management stated the FDA expressed openness during a recent Type C meeting to considering existing clinical trial data and real-world evidence in support of approval decisions without requiring additional trials.
The company linked that regulatory approach to broader federal interest in using real-world evidence for psychiatric drug approvals, citing a recent executive order and congressional appropriations language tied to treatments for suicidal depression and PTSD.
NRx additionally formed a new subsidiary, NRx Defense Systems, in April to support military-focused neuroplasticity and TMS initiatives in partnership with Zeta Surgical.
HOPE Therapeutics continued expanding during the quarter, operating five Florida clinics focused on severe depression and PTSD treatment. The company expects the network to grow to at least eight locations by the end of the second quarter.
NRx also broadened its pipeline through a pending acquisition of assets from Swiss biotechnology company Geneuro SA, including patents, antibodies, cell lines, and Phase 2 clinical data tied to therapies targeting human endogenous retroviruses associated with schizophrenia, ALS, multiple sclerosis, autism, and Type 1 diabetes.
For the quarter ended March 31, NRx reported a net loss of $1.4 million, compared with a $5.5 million loss a year earlier. Operating loss widened to $4.7 million from $3.8 million as the company increased spending on regulatory filings, manufacturing preparation, clinic expansion, intellectual property development, and pipeline growth initiatives.
NRx ended the quarter with approximately $6.7 million in cash and cash equivalents. The company later raised roughly $7 million through its at-the-market stock offering program and stated existing cash resources, anticipated clinic revenue growth, and cost-cutting initiatives are expected to support operations through 2026.
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