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NRX Pharmaceuticals, Inc. - NRXP STOCK NEWS

Welcome to our dedicated page for NRX Pharmaceuticals news (Ticker: NRXP), a resource for investors and traders seeking the latest updates and insights on NRX Pharmaceuticals stock.

NRX Pharmaceuticals, Inc. (Nasdaq: NRXP) is a clinical-stage, small-molecule pharmaceutical company dedicated to developing novel therapeutics for central nervous system disorders and life-threatening pulmonary diseases. The company's flagship products include ZYESAMI (Aviptadil), aimed at treating COVID-related respiratory failure, and NRX-100/101, the first sequential drug regimen specifically designed for bipolar depression in patients with acute suicidal ideation and behavior.

Recently, NRX Pharmaceuticals announced a public offering of its common stock to raise funds for working capital, general corporate purposes, and to repay certain debts. The proceeds will also support the initiation of a national treatment protocol and a safety database.

Among its most notable developments, the company is advancing NRX-101, designated as an FDA Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRX Pharmaceuticals has strategic partnerships with Alvogen and Lotus for the development and marketing of NRX-101.

The company also oversees Hope Therapeutics, focusing on the development and marketing of IV ketamine for the acute treatment of suicidality and depression, leveraging a digital therapeutic-enabled platform to augment clinical benefits.

NRX Pharmaceuticals' robust pipeline includes plans for a New Drug Application for HTX-100 (IV ketamine) based on promising clinical trial results. It has also received Fast Track Designation from the FDA for the development of ketamine as part of its treatment protocol for acute suicidality.

Furthermore, NRX Pharmaceuticals is exploring the use of NRX-101 for chronic pain and complicated UTI, marking its potential to address significant unmet medical needs across various therapeutic areas. The company remains committed to improving patient outcomes and advancing its innovative therapies through rigorous clinical trials and strategic collaborations.

News

NRx Pharmaceuticals Announces FDA Clearance of its Investigational New Drug (IND) Application for NRX-101 in the Treatment of Complicated Urinary Tract Infections

Rhea-AI Summary
NRx Pharmaceuticals, Inc. (NRXP) receives FDA clearance for NRX-101 to treat complicated Urinary Tract Infections. The potential to initiate a registrational study in 2024, with the aim to develop and commercialize NRX-101 for cUTI. The company plans to spin out a new company for this initiative, with the manufacturing phase of NRX-101 complete, and Composition of Matter patent protection secured. Michael Manyak, MD, an internationally-recognized urologist, joins as Lead Clinical Advisor for the initiative.
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NRx Pharmaceuticals Provides Notice of Annual Meeting of Shareholders

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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced their 2023 Annual Meeting of Stockholders to be held on December 19, 2023, in virtual-only format. The meeting will address the election of Janet Rehnquist as a member of the Company's Board of Directors and the planned spinoff of the IV Ketamine focused company, Hope Therapeutics, Inc.
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NRx Pharmaceuticals to Participate in LifeSci Corporate Access Event

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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) will be participating in the LifeSci Partners Corporate Access Event from January 8th through the 10th in San Francisco. The company anticipates substantial growth in 2024, including the filing of its first New Drug Application. NRx Pharmaceuticals will update investors on recent progress, upcoming clinical and regulatory catalysts, and answer questions.
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NRx Pharmaceuticals to Present at Noble Capital Markets' 19th Annual Emerging Growth Investor Conference

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NRx Pharmaceuticals, Inc. (NRXP) will be presenting a corporate overview at the Noble Capital Markets' 19th Annual Emerging Growth Investor Conference on December 4th, 2023. Dr. Jonathan Javitt, Founder and Chief Scientist, will deliver the presentation at Florida Atlantic University in Boca Raton, Fla. The event will include in-person one-on-one meetings with management.
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NRx Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Update

Rhea-AI Summary
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced four near-term milestones, including the completion of the Phase 2b/3 trial of NRX-101 in Treatment Resistant Bipolar Depression and initiation of potential spinout initiatives in 2023/early 2024. The company also opened an Investigational New Drug application with the FDA to treat chronic pain with NRX-101 and received data from randomized, controlled trials demonstrating safety and efficacy of IV ketamine in treating suicidal depression.
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NRx Pharmaceuticals to Report Third Quarter 2023 Financial Results on November 14, 2023

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NRx Pharmaceuticals, Inc. will release its third quarter 2023 financial results on November 14, 2023, and host a conference call to discuss the results and provide a corporate update. The updates are expected to cover progress on the development of NRX-101 for bipolar depression, clinical trial data timing, and plans for NRX-100 (ketamine) development.
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NRx Pharmaceuticals and Nephron Pharmaceuticals Announce Joint Agreement to Develop Intravenous Ketamine to Treat Suicidal Depression

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NRx Pharmaceuticals and Nephron Pharmaceuticals have signed a development and manufacturing agreement to produce a tamper and diversion-resistant formulation of ketamine for treating suicidal depression. The partners aim to submit a New Drug Application by March 1, 2024, with a finished drug targeted for November 2024, pending FDA approval. Ketamine has shown promise in rapidly reducing suicidal thoughts, but no FDA-approved formulation currently exists for this purpose.
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NRx Pharmaceuticals Announces Signing of a Development Agreement for the Manufacture of Ketamine to Treat Suicidality and Depression

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NRx Pharmaceuticals has signed a development contract to manufacture intravenous Ketamine suitable for treating depression and suicidality. The company plans to file a New Drug Application for Ketamine in 2024 based on existing clinical data and newly-developed manufacturing protocols. The supply of Ketamine is currently limited and not labeled for depression treatment. NRx Pharmaceuticals and its manufacturing partner will release more information in an upcoming 8K filing.
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NRx Pharmaceuticals Announces Further Alignment with FDA on Initiation of Registrational Trials for NRX-101 in the Treatment of Chronic Pain

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NRx Pharmaceuticals receives FDA approval to proceed with a pharmacokinetic study for NRX-101 in the treatment of Chronic Pain. The requirements are consistent with those for Bipolar Depression, potentially allowing for registrational studies in 2024.
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NRx Pharmaceuticals Announces Strategic Change in Development of NRX-100 (IV Ketamine) at Dawson James Small Cap Investor Conference

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NRx Pharmaceuticals accelerates plans to develop commercial form of intravenous ketamine for treating acute depression and suicidality
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FAQ

What is the current stock price of NRX Pharmaceuticals (NRXP)?

The current stock price of NRX Pharmaceuticals (NRXP) is $1.26 as of November 22, 2024.

What is the market cap of NRX Pharmaceuticals (NRXP)?

The market cap of NRX Pharmaceuticals (NRXP) is approximately 14.9M.

What is NRX Pharmaceuticals' primary focus?

NRX Pharmaceuticals focuses on developing novel therapeutics for central nervous system disorders and life-threatening pulmonary diseases.

What are NRX Pharmaceuticals' key products?

The key products include ZYESAMI (Aviptadil) for COVID-related respiratory failure and NRX-100/101 for bipolar depression with acute suicidal ideation.

What is the significance of NRX-101?

NRX-101 is an FDA-designated Breakthrough Therapy aimed at treating suicidal treatment-resistant bipolar depression and chronic pain.

Who are NRX Pharmaceuticals' strategic partners?

NRX Pharmaceuticals has partnered with Alvogen and Lotus for the development and marketing of NRX-101.

What recent developments has NRX Pharmaceuticals announced?

The company has announced a public offering to raise funds for working capital, initiating a national treatment protocol, and repaying debts.

What is Hope Therapeutics?

Hope Therapeutics is a subsidiary of NRX Pharmaceuticals, focusing on the development and marketing of FDA-approved intravenous ketamine for acute suicidality and depression.

What is the purpose of the public offering announced by NRX Pharmaceuticals?

The public offering aims to raise funds for working capital, general corporate purposes, and to repay certain outstanding debts.

What are the future plans for NRX-101?

NRX Pharmaceuticals plans to expand NRX-101’s use for chronic pain and complicated UTI, and potentially submit a New Drug Application based on clinical trial results.

Has NRX Pharmaceuticals received any special designations from the FDA?

Yes, NRX Pharmaceuticals has received Fast Track Designation from the FDA for the development of ketamine (NRX-100) as part of its treatment protocol for acute suicidality.

What is the financial condition of NRX Pharmaceuticals as of the latest update?

As of the latest update, NRX Pharmaceuticals is in the process of raising funds through a public offering and has received $5 million from a milestone payment, improving its working capital situation.

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NRX Pharmaceuticals, Inc.

Nasdaq:NRXP

NRXP Rankings

#5410 Ranked by Market Cap
N/A Ranked by Dividends

NRXP Stock Data

14.94M
9.24M
23.56%
6.05%
6.35%
Biotechnology
Pharmaceutical Preparations
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United States of America
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