NRX Pharmaceuticals

NRXP

時価総額 $1.13億

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.

DARPA states that the program, if successful, will fundamentally change the Standard of Care for Treatment Resistant Depression. The Military has recognized that current treatments for depression are not deployable in operational military settings.

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) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.09. This compares to a loss of $0.98 per share a year ago.