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.
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NRx Pharmaceuticals, Inc. (NRXP) advances NRX-101 through registrational trials with a $5 million milestone payment from partners Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. The company remains eligible for up to $324 million in future milestones and double-digit royalties upon approval. The payment extends NRx's cash runway.
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NRx Pharmaceuticals achieves enrollment completion for NRX-101 trial in suicidal treatment-resistant bipolar depression, partnering with Lotus Pharmaceutical for Asia Pacific market. Lotus reports a 45% increase in revenues. NRx anticipates trial readout in Q2, emphasizing the critical need for innovative treatments in mental health.
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NRx Pharmaceuticals, Inc. announces the incorporation of HOPE Therapeutics, a biotechnology company dedicated to bringing NRX-100 (IV Ketamine), re-designated HTX-100, as a potentially lifesaving treatment option for patients with Suicidal Depression. The company, initially owned by NRx and its current shareholders, will file a New Drug Application (NDA) for HTX-100 in the first half of 2024, and is taking steps to gain a public listing. The shareholder meeting planned for February 7, 2024, is cancelled and will be rescheduled if necessary. The company aims to provide FDA-approved IV Ketamine in a diversion- and abuse-deterrent presentation, with plans for state-of-the-art patient and reimbursement support. NRx also expects to convene a shareholder meeting in the coming weeks to vote on the planned structure of the spin-out of Hope Therapeutics and the stock dividend.
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NRx Pharmaceuticals, Inc. (NRXP) has announced the completion of enrollment in its Phase 2b/3 study of NRX-101, a patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression. The enrollment of 74 patients exceeded the original target of 70 patients, triggering a milestone payment from Alvogen, who will be responsible for further development and commercialization costs for this program. The primary efficacy endpoint is the reduction in depression as measured on the MADRS scale, with top-line results expected later this quarter.
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NRx Pharmaceuticals, Inc. (NRXP) has been granted a transfer of its listing to The Nasdaq Capital Market, subject to the company evidencing compliance with all applicable criteria for continued listing. The company aims to meet the market value of listed securities and the minimum bid price requirements by April 16, 2024. NRx is also working towards filing its first New Drug Application for NRX-100 (ketamine) for the treatment of acute suicidal depression and announcing top line results from its phase 2b/3 trial of NRX-101 (D-cycloserine/lurasidone) in the treatment of suicidal bipolar depression.
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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has received Qualified Infectious Disease Product (QIDP) and Fast Track designation from the US FDA for NRX-101 in the treatment of complicated urinary tract infections (cUTI) and pyelonephritis. These designations grant Priority Review and an additional 5 years of data-exclusivity to NRX-101. The FDA also granted NRX-101 Fast Track designation for cUTI, which allows for rolling submission of the Company's New Drug Application. The active antibiotic ingredient of NRX-101 is D-cycloserine (DCS) that was developed as an antibiotic in the 1950's and used worldwide for the treatment of tuberculosis. NRx is seeking partners for commercialization of NRX-101. The press release emphasizes the need for a new therapeutic life to DCS as an antibiotic due to the increased antibiotic resistance rendering standard treatments for UTI ineffective in many cases. The company is optimistic that NRX-101 will have a minimal tendency to disrupt the microbiome of the intestine and potentially lead to reduced risk of C. difficile infection.
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NRx Pharmaceuticals, Inc. (NRXP) announced their selection to give the keynote address at the Sachs Neuroscience Innovation Forum on January 7, 2024, discussing the benefits and risks of ketamine in treating suicidal depression. They plan to file a New Drug Application for ketamine in 2024 in the US and EU, partnering with the Fondation FundaMental of Paris, FR.
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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has announced plans to achieve compliance with Nasdaq market requirements related to minimum bid price and total Market Value of Listed Securities. The company aims to present its full compliance plan to Nasdaq on January 4, 2024, based on achieving clinical and regulatory milestones. NRx has demonstrated compliance with the $35 million MVLS since Dec 18, 2023, and aims to maintain compliance with this requirement going forward, rendering NRXP eligible for a second 180-day compliance period to reach a bid price of $1.
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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announces the election of Janet Rehnquist, former Inspector General of the US Dept. of Health and Human Services, to its Board of Directors. Ms. Rehnquist will chair the compliance and nominating committees, bringing her extensive experience in healthcare law and compliance matters to the company. NRx Pharmaceuticals is focused on developing drug treatments for urgent unmet medical needs in CNS and mental health, particularly suicidal depression.
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NRx Pharmaceuticals, Inc. (NRXP) announced the signing of a License Data and Technical Information Agreement with Columbia University for rights to data from a randomized, active-controlled trial of 80 patients hospitalized for Acute Suicidality in Depression. The trial demonstrated a rapid and statistically significant reduction in Suicidal Ideation (SSI) at day 1 (p=0.0003) and in depression (P=0.0234) among patients randomized to IV Ketamine compared to those randomized to midazolam. NRx plans to present the data from these two trials to FDA in support of a New Drug Application to be filed in q1 2024.
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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.
NRX Pharmaceuticals, Inc.
Nasdaq:NRXP
NRXP Rankings
NRXP Stock Data
14.94M
9.24M
23.56%
6.05%
6.35%
Biotechnology
Pharmaceutical Preparations
United States of America
WILMINGTON