SEC Form EFFECT filed by NRX Pharmaceuticals Inc.
| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | December 22, 2025 5:00 P.M. |
| Form: | S-3 | ||||||
| |||||||
| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | December 22, 2025 5:00 P.M. |
| Form: | S-3 | ||||||
| |||||||
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 9/8/2025 | $40.00 | Buy | H.C. Wainwright |
| 4/2/2025 | $18.00 | Buy | BTIG Research |
DEFA14A - NRX Pharmaceuticals, Inc. (0001719406) (Filer)
DEF 14A - NRX Pharmaceuticals, Inc. (0001719406) (Filer)
8-K - NRX Pharmaceuticals, Inc. (0001719406) (Filer)
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. In addition to reviewing the Company's financial results for the fiscal year ended December 31, 2025, the Company will provide an update on the significant progress achieved across its drug development programs and the HOPE Therapeutics clinical network, milestones that bring the Company closer to its founding mission of preventing suicide and transforming the treatment of depression and PTSD to improve the lives of patient
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. This communication is deemed preliminary until final supervisory review.NRx continues to anticipate an FDA GDUFA decision on its ANDA application in Summer 2026 as previously announced.The ANDA process is focused on offering a preservative-free alternative in the existing ketamine market through the FDA Office of Generic Drugs and is separate from NRx's path to a New Drug Application to use ketamine in the
NRx has received confirmatory FDA minutes from in-person Type C meeting attended by leadership of FDA Division of Psychiatry, FDA Office of Neuroscience, and FDA Center for Drug Evaluation and Research.Minutes are consistent with previously announced oral guidance outlining a path to New Drug Approval of NRX-100 for a broadened indication of treating depression, including patients with suicidality.FDA confirmed willingness to review existing Adequate and Well Controlled Clinical Trial data as Substantial Evidence of Efficacy together with Real World Evidence from Osmind, Inc. as confirmatory evidence of efficacy.No additional clinical trials were requested.Company intends to sumbit its New D
4 - NRX Pharmaceuticals, Inc. (0001719406) (Issuer)
3 - NRX Pharmaceuticals, Inc. (0001719406) (Issuer)
4 - NRX Pharmaceuticals, Inc. (0001719406) (Issuer)
H.C. Wainwright initiated coverage of NRx Pharmaceuticals with a rating of Buy and set a new price target of $40.00
BTIG Research initiated coverage of NRx Pharmaceuticals with a rating of Buy and set a new price target of $18.00
4 - NRX Pharmaceuticals, Inc. (0001719406) (Issuer)
Prof. Brown is a pioneer in Transcranial Magnetic Stimulation (TMS) and serves as current President of the Clinical TMS Society and Editor-in-Chief of the Transcranial Magnetic Stimulation journal.Extensive publication history in the science of neuroplasticity and its relationship to healing depression and PTSD.Unique background in charting a path for forward deployment of TMS with neuroplastic medication to treat depression and PTSD in military personnel, veterans, and first responders. WILMINGTON, Del., March 02, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a clinical-stage biopharmaceutical company, today announced that it has appointed Prof. Joshua C. Brown, MD, P
Cohen and Associates has more than a decade of leadership in interventional psychiatry and Transcranial Magnetic Stimulation (TMS) Dr. Rebecca Cohen has joined HOPE as Medical DirectorImmediate expansion is planned in Western Florida and Palm BeachAcquisition expected to be accretive to HOPE Therapeutics revenue and EBITDA MIAMI, Oct. 20, 2025 (GLOBE NEWSWIRE) -- HOPE Therapeutics™, Inc. ("HOPE"), an interventional psychiatry network owned by NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), today announced the acquisition of a strategic interest in Cohen and Associates, LLC ("Cohen, LLC") and its incorporation into the HOPE Network. Additionally, Rebecca Cohen, MD has joined HOPE as Medical Dire
WILMINGTON, Del., July 29, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", or the "Company"), today announced that its CEO and Chairman will join a fireside chat at BTIG Virtual Biotechnology Conference on July 29 – 30, 2025. Prof. Jonathan Javitt, MD, MPH will join Prof. Samuel Wilkinson, MD, of the Yale School of Medicine, and BTIG Research Analyst Dr. Thomas Shrader for a fireside chat to discuss neuroplasticity in the treatment of CNS disorders at 8:00 a.m. EDT on Wednesday, July 30, 2025. Prof. Wilkinson is a widely published psychiat
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. In addition to reviewing the Company's financial results for the fiscal year ended December 31, 2025, the Company will provide an update on the significant progress achieved across its drug development programs and the HOPE Therapeutics clinical network, milestones that bring the Company closer to its founding mission of preventing suicide and transforming the treatment of depression and PTSD to improve the lives of patient
WILMINGTON, Del., Dec. 02, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will host a corporate update conference call on Tuesday, December 2, 2025 at 9:00am ET. The call will provide a corporate update, including recent clinical, regulatory, and operational developments. 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 domestically 1-800-717-1738 or internationally 1-646-307-1865. About NRx P
NRx has refiled its Abbreviated New Drug Application for KETAFREE™ (preservative free ketamine), received supportive correspondence from FDA, and expects Q2 2026 GDUFA date.HOPE Therapeutics is now operating three revenue-generating facilities in Florida and expects six or more by year-end providing neuroplastic drugs, transcranial magnetic stimulation, hyperbaric therapy, and digital therapeutics to treat suicidal depression and PTSD.NRx has secured operating capital anticipated to be sufficient for drug development operations through July 2026. The Company additionally expects to increase revenue from clinical operations.NRx received FDA grant of Fast Track Designation for NRX-100 in the t
SC 13D - NRX Pharmaceuticals, Inc. (0001719406) (Subject)
SC 13D/A - NRX Pharmaceuticals, Inc. (0001719406) (Subject)
SC 13D - NRX Pharmaceuticals, Inc. (0001719406) (Subject)