NRXP

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.

WILMINGTON, Del., Sept. 08, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced that the management team will participate in three upcoming investor conferences in September 2026.

NRx Pharmaceuticals, Inc. (NRXP) Q2 2026 Earnings Call Transcript

Key recent and second quarter highlights include: Completed first-cycle FDA review of the Company's ANDA for preservative-free ketamine with no drug-related major deficiencies. The sole remaining item, a manufacturer's attestation on the vial, has been submitted to FDA.

NRx Pharmaceuticals, Inc. (NRXP) Discusses FDA First Cycle Review Outcome and Commercialization Plans for Preservative Free Ketamine Transcript

NRx Pharmaceuticals NASDAQ: NRXP said it has completed the first-cycle U.S. Food and Drug Administration review of its abbreviated new drug application, or ANDA, for preservative-free ketamine, with one remaining issue related to the product's vial connector.

MIAMI, Aug. 07, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will host a conference call and Q&A session on Monday, August 10, 2026 at 8:30 a.m. Eastern Time to discuss the FDA's completion of first-cycle review of the Company's ANDA for preservative-free ketamine, announced earlier today.