NRX Pharmaceuticals, Inc. NRXP

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.The SPARC-TMS Single Day treatment protocol, which involves the use of Robotic Neuronavigated Transcranial Magnetic Stimulation (TMS) augmented by NRx’s neuroplastic investigational drug NRX-101, is based on a recently completed randomized-controlled t

Abbreviated New Drug Application (ANDA) Amendment related to the drug vial for preservative-free ketamine has been reclassified from a Major Amendment to a Minor Amendment.FDA has revised the Generic Drugs User Fee Act (GDUFA) Goal Date to November 10, 2026. 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 communi

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. The patent (EP 3 570 878 B1) covers a novel monoclonal antibody (GNK-301) developed by GeNeuro and scientists at the US

HOPE is the first Interventional Psychiatry network to deploy Zeta Surgical's newly FDA-cleared TMS Robotic System; the HOPE clinical team is completing orientation and training at Zeta Surgical's headquarters in Boston ahead of deployment in HOPE's Florida clinicsThe Zeta TMS Robotic System's AI-driven software adjusts the TMS coil in real time with submillimeter precision, building on the Zeta TMS Navigation System HOPE implemented earlier this summerDeployment supports SPARC-TMS, NRx's trial

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. Moody Capital Solutions 2026 Disruptive Growth & Life Sciences ConferenceCompany PresentationPresenter: Jonathan Javitt, M.D., M.P.H., Founder, Chairman and Chief Executive Officer of NRx PharmaceuticalsL

Moby summary of NRx Pharmaceuticals, Inc.'s Q2 2026 earnings call

NRX Pharmaceuticals reports improved net loss, strong cash position, and key regulatory progress for its ketamine and CNS pipeline.

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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.Initiation of commercial scale manufacturing of preservative-free ketamine building to launch stock of 5 million doses to be ready for commercialization in 2026.Selected by the Defense Advanced Research Projects Agency (DARPA) as

Conference Call 8:30 a.m. ET, Monday, August 10, 2026MIAMI, 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. Participating on the call w

FDA identified no major deficiencies related to the ketamine drug product, ingredients, proposed labeling, CMC, or other drug-related review matters.Remaining item relates to manufacturer certification for a luer lock vial already used in three FDA-approved ANDA products with 11.9 million units shipped over the past 12 months without complaints, returns, adverse events, or recalls.No new clinical, safety, efficacy, or drug-related data are required for ANDA approval.Following an August 6, 2026 c

We recently compiled a list of the 7 Best Psychedelic Stocks to Buy According to Analysts. NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) is one of the best psychedelic stocks on our list. TheFly reported on June 25 that NRXP issued a statement responding to claims made by Kadima Neuropsychiatry Institute regarding the failed acquisition of Kadima by HOPE […]