NRXP

NRx Pharmaceuticals, Inc. (NRXP) Discusses FDA Approval of Preservative-Free Ketamine Transcript

NRx Pharmaceuticals NASDAQ: NRXP said the U.S. Food and Drug Administration approved its abbreviated new drug application for preservative-free ketamine injection, marking the company's first approved product and its transition from a development-stage company to a commercial pharmaceutical company.

WILMINGTON, Del., Oct. 30, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, “NRx” or “the Company”), a commercial biopharmaceutical company developing medicines that target depression, PTSD, and suicidality today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Abbreviated New Drug Application (ANDA) for Preservative-Free Ketamine. The approval comes ahead of the FDA-announced November 10, approval goal date.

Company to issue press release before market open; conference call to follow at 8:30 a.m. ET Company to issue press release before market open; conference call to follow at 8:30 a.m. ET

WILMINGTON, N.C., Oct. 19, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, “NRx” or “the Company”), a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA receptor platform for the treatment of central nervous system disorders, today announces completion of three Process Validation lots of preservative free Ketamine produced under commercial conditions in anticipation of the November 10 GDUFA (Generic Drug User Fee Amendments) Goal Date. Process Validation1 is the final step in the drug manufacturing process required to demonstrate compliance with FDA Good Manufacturing Practices (GMP).

In advance of November 10, 2026, GDUFA goal date, all requested changes were classified as “MINOR.” NRx was requested to prepare and submit labels with the proprietary name currently under review by FDA.

WILMINGTON, Del., Sept. 15, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, today announced that it has received a written communication from the Director of Regulatory Operations of the FDA Office of Generic Drugs advising the Company that the amendment to its Abbreviated New Drug Application (ANDA), previously classified as a Major Amendment, has been reclassified as a Minor Amendment.

KETAFREE could turn NRXP's ketamine opportunity into a commercial business, provided FDA approval leads to a successful launch. NRXP's HOPE gives them clinical infrastructure, even though it still has a relatively small revenue base. That's why their bull case ultimately depends on successfully commercializing KETAFREE in the future.

Invention is based on the discovery that ALS may be caused by reactivation of Human Endogenous Retrovirus K (HERV K) Envelope protein (K Env), already coded in the “dark genome” of all people. K Env is found in the spinal fluid of more than 75% of people with ALS and has been shown to produce the neurodegenerative findings of ALS in experimental animals and human neuron cells.

WILMINGTON, Del., Sept. 11, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, today announced that its subsidiary, HOPE Therapeutics, Inc. ("HOPE"), will be the first Interventional Psychiatry to deploy Zeta Surgical's newly FDA-cleared Zeta TMS Robotic System, with clinical staff now in training ahead of deployment in Florida.