NRXP

8-K - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

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 prime contractor for SPARC-TMS, an FDA-approved Phase 2/3 trial of NRX-101 with robotic TMS. Anticipated non-dilutive funding exceeds $11.5 million, subject to completion of contractingThe Company is

10-Q - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

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. Participating on the call will be Jonathan Javitt, MD, MPH, Founder and Chief Executive Officer; Glenn Tyson, Chief Commercial Officer; and Chaim Hurvitz, Director, former director of Teva and President of the Teva International Group. Questions will cover both the regulatory p

8-K - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

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 clarification meeting attended by senior FDA leadership, FDA committed to reviewing the requested certification in the shortest possible review cycle.NRX believes completion of first-cycle ANDA review

8-K - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

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 making a series of unfounded allegations related to the non-acquisition of Kadima by HOPE Therapeutics, Inc., a majority-owned subsidiary of the Company ("HOPE"). As disclosed in recent filings with the Securities and Exchange Commission (the "SEC"), NRx has compelled arbitration with Kadima over Kadima’s failure to meet key closing conditions contemplated in the related transaction documents includin

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 careAI-powered, sub-millimetric image guidance is now being applied in HOPE's outpatient TMS workflows for patients with Major Depressive Disorder and other CNS conditionsMilestone advances HOPE's interventional psychiatry platform and aligns with NRx's planned trial of NRX-101 in combination with robotic-enabled TMS in civilian and military treatment facilities (the SPARC-TMS trial). WILMINGTON, Del., June 25, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", "NRx" or

SARASOTA, Fla, and BOSTON, June 23, 2026 /PRNewswire/ -- ZETA SURGICAL and HOPE Therapeutics, an NRx Pharmaceuticals company (NASDAQ:NRXP), today announced the first patient treatment with the FDA-cleared Zeta TMS Navigation System at a HOPE Therapeutics clinic in Sarasota. HOPE has installed Zeta TMS Navigation Systems at clinics in West Palm Beach and Sarasota, with Zeta-navigated patient treatments beginning at both locations this week. TMS is a non-invasive therapy used primarily for treatment-resistant depression, which affects approximately one-third of patients with major

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 TMS and has initiated a pivotal clinical trial in both civilian and military treatment facilities.The Expanded Access protocol is designed to make NRX-101 available under FDA-authorized compassionate care mechanisms for patients who cannot access the pivotal trial.Physicians who wish to provide NRX-101 in association with accelerated TMS for patients with Treatment-Resistant Depression may register at

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.IV ketamine patients demonstrated significantly higher rates of remission (OR 1.51; P<.001) from depression and response (OR 1.22; P<.003) compared to patients treated with nasal esketamine.The primary study limitation is that treatment assignments were not randomized.Use of Real World Evidence for approval of drugs to treat depression has been emphasized in a recent White House Executive Order and recent Congressio

8-K - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

WILMINGTON, Del., June 04, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced the closing of its previously announced underwritten public offering (the "Offering") of shares of its common stock, par value $0.001 per share ("Common Stock") at a public offering price of $3.50 per share of Common Stock. The gross proceeds of the Offering were approximately $22.3 million before deducting underwriting discounts and commissions in the Offering and other estimated expenses payable by the Company, including exercise of the underwriters' option to purchase additional shares of common

424B5 - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

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, par value $0.001 per share ("Common Stock") at a public offering price of $3.50 per share of Common Stock. The Company has also granted the underwriters a 30-day option to purchase up to an additional 857,142 shares of Common Stock. The gross proceeds of the Offering will be approximately $20.0 million (or $23.0 million if the underwriter exercises its option to purchase additional shares of Co

8-K - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

424B5 - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

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 underwritten public offering (the "Offering"). The Company also expects to grant to the underwriter of the Offering a 30-day option to purchase up to an additional 15% of the shares of Common Stock sold in the Offering on the same terms and conditions. The Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed or as to t

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.Pooled analysis of three prospective observational studies demonstrated 90% within-person concordance between EMOCARE scores and clinician-rated MADRS (r = 0.895; p = 0.016).EMOCARE also achieved strong sensitivity to symptom change against PHQ-9 (ρ = 0.834; p < 0.001) on consecutive-visit measurements.The validated technology is being deployed across the Hope Therapeutics interventional psychiatry network as a patient-facing self-monitoring and

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 conditionsInstallation complements HOPE's interventional psychiatry platform and aligns with NRx's previously announced clinical trial of NRX-101 in combination with robotic-enabled TMS WEST PALM BEACH, Fla., May 27, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, today announced that its wholly-owned subsidiary, HOPE Therapeutics, Inc. ("HOPE"), has become the fir

25-NSE - NRX Pharmaceuticals, Inc. (0001719406) (Subject)

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 bioequivalence, labeling, drug product, drug substance, and safety.Initiation of commercial manufacturing of Ketamine at the 1 million dose per month level with recent FDA inspection of the manufacturing facility and granting of inspection status consistent with launch of an ANDA drug.Completed a Type C meeting with the FDA Division of Psychiatry Products and CDER leadership, in which the Agency e

SCHEDULE 13G/A - NRX Pharmaceuticals, Inc. (0001719406) (Subject)

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, 2026 via press release, which will be available on the Company's website at https://ir.nrxpharma.com/. The Company will host a conference call at 8:00am ET the same day. A live webcast of the conference call will be available on the Company's website at https://ir.nrxpharma.com/events. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestica