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.
Conference Call 8:30 a.m. ET, Monday, August 10, 2026 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,
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
WILMINGTON, Del., June 25, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx” or the “Company”) today issued the following statement in response to recent public claims made by Kadima Neuropsychiatry Institute (“Kadima”). Kadima issued a public statement on June 24, 2026
First Zeta-navigated TMS treatments have begun at HOPE Therapeutics clinics in West Palm Beach and Sarasota, Florida, marking the transition from research deployment to active patient care AI-powered, sub-millimetric image guidance is now being applied in HOPE's outpatient TMS workflows for
D-Cycloserine (DCS) has been reported to augment the effect of Transcranial Magnetic Stimulation (TMS) in remission from depression and suicidality in several published clinical studies. NRx Pharmaceuticals is developing NRX-101, a fixed dose combination of DCS+lurasidone for the augmentation of
Osmind presented a retrospective comparative study of de-identified electronic health record data in a sample of 8,224 patients with treatment resistant depression treated with IV ketamine and 1,830 patients treated with intranasal esketamine from 800 community psychiatry clinics.
Offering was led by B Group Capital with significant participation from, among others, Columbia Threadneedle Investments, Corbets Capital, Venture 76, and Mossrock Capital WILMINGTON, Del., June 04, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals” or the
WILMINGTON, Del., June 03, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals” or the “Company”), a clinical-stage biopharmaceutical company, today announced the pricing of an underwritten public offering (the “Offering”) of 5,714,286 shares of its common stock,
WILMINGTON, Del., June 02, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals” or the “Company”), a clinical-stage biopharmaceutical company, today announced that it intends to offer shares of its common stock, par value $0.001 per share (“Common Stock”) in an
EMOCARE is a smartphone-based passive monitoring tool that generates a continuous, real-time measure of depression from patient voice, facial expression, motion, and screen behavior, and is the first passive monitoring tool for psychiatric conditions.
Deployment at HOPE's West Palm Beach clinic brings AI-powered, sub-millimetric image guidance to the delivery of Transcranial Magnetic Stimulation (TMS) for patients with Major Depressive Disorder and other neurological conditions Installation complements HOPE's interventional psychiatry platform
Key highlights from the first quarter of operations under the expanded management team include the following: Anticipated FDA decision on the Company's ANDA for Preservative-Free Ketamine in Q3 2026, with favorable preliminary determinations already received from the FDA Office of Generic Drugs on
WILMINGTON, Del., May 14, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical-stage biopharmaceutical company, today announced that it will release its first quarter 2026 financial results before the market opens on Monday, May 18,
Preliminary research suggests that D-cycloserine significantly enhances the effect of Transcranial Magnetic Stimulation (TMS) Trial is planned to be conducted at a leading US academic teaching hospital, three HOPE Therapeutics Clinics, and two military treatment facilities Company targeting
Based on FDA Office of Generic Drugs guidance previously announced, NRx has transmitted an initial GMP manufacturing order to its US-based manufacturer. NRx has completed confirmatory GMP audits of manufacture and is prepared for pre-approval inspection.
NRx has received a positive review letter (Discipline Review Letter) addressing Drug Quality requesting only “Minor” administrative changes NRx conducted a meeting with leadership of the FDA Office of Generic Drugs in which support was voiced for the potential approval of the Abbreviated New Drug
President Trump signed an Executive Order: ACCELERATING MEDICAL TREATMENTS FOR SERIOUS MENTAL ILLNESS on April 18, 2026. The order directs acceleration of research and lowered barriers to approvals of psychedelic medications to treat depression, PTSD, and suicidality.
Dr. Dennis K. McBride, PhD (CAPT, Medical Service Corps, US Navy, Ret., Distinguished Research Fellow, National Defense University, and former senior executive, Office Secretary of Defense) to serve as first President of NRx Defense Systems Development initiative to be conducted through NRx Defense
Mr Tyson has both clinical experience treating patients with serious mental health disorders and 25 years of successful industry commercial experience in the development and sales of medications in this field Mr. Tyson is appointed as NRx anticipates approval of an ANDA for preservative-free
NRx has received a letter from the FDA Office of Generic Drugs indicating preliminary alignment on labeling for NRx’s preservative-free ketamine product. Labeling remains subject to final supervisory review. NRx previously received a preliminary determination of bioequivalence for this product.
Hope Therapeutics (subsidiary of NRx Pharmaceuticals, Nasdaq: NRXP) partners with Emobot Health to deploy its AI-powered "Depression Thermometer" across its interventional psychiatry clinic network. Emobot's platform passively monitors depression, bipolar disorder and anxiety disorders via
Key highlights for the first full year of operation under the new management team include: A year-over-year reduction in operating expenses with $7.8 Million cash on hand at year end. With ongoing revenue from operations and current ATM trends, the Company anticipates adequate resources to support
WILMINGTON, Del., March 19, 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 at 8:00am ET on Tuesday, March 24, 2026.
Determination of bioequivalence to the Reference Listed Drug is essential for approval of an Abbreviated New Drug Application (ANDA). FDA has advised NRx in written correspondence that it has not identified any bioequivalence deficiencies in the Company’s Preservative-Free Ketamine product.