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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal Depression
Prnewswire· 2024-12-30 13:03
Aiming to be the first FDA-approved medication to treat suicidal depression Designed to help address the needs of the more than 13 million Americans who seriously consider suicide each year (CDC) Completion of NDA filing expected in the first quarter of 2025 Company to participate in 1x1 meetings in San Francisco during the Annual J.P. Morgan Healthcare Conference on January 13-16, 2025, in San Francisco, CA.  To schedule meetings, please contact [email protected] WILMINGTON, Del., Dec. 30, 2024 /PRNewswir ...
NRx Pharmaceuticals (NRXP) Upgraded to Buy: Here's Why
ZACKS· 2024-11-27 18:01
NRx Pharmaceuticals, Inc. (NRXP) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a c ...
NRx Pharmaceuticals (NASDAQ: NRXP) Announces Participation in the NobleCon20 - Noble Capital Markets' Twentieth Annual Emerging Growth Equity Conference December 3-4, 2024
Prnewswire· 2024-11-26 13:03
 WILMINGTON, Del., Nov. 26, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that Dr. Jonathan Javitt, Chairman, CEO and Chief Scientist will present at NobleCon20 - Noble Capital Markets' Twentieth Annual Emerging Growth Equity Conference at Florida Atlantic University, Executive Education Complex, in Boca Raton, FL.- on Tuesday December 3, 2024 at 1:00PM Eastern Standard Time. HOPE Therapeu ...
NRx Pharmaceuticals (NASDAQ:NRXP) Announces Publication of Paper Entitled "Quality Assurance of Depression Ratings in Psychiatric Clinical Trials"
Prnewswire· 2024-11-25 13:03
NRx-developed training and monitoring methodology in recently completed phase 2b/3 clinical trial of NRX-101 documents higher interrater reliability (IRR) on primary endpoint (MADRS depression scale) than previously reported industry standards Positive implications for conduct of future registration trials for NRX-101 and similar medications. Published in the peer reviewed American Journal of Clinical Psychopharmacology WILMINGTON, Del., Nov. 25, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP ...
NRx Pharmaceuticals (NASDAQ:NRXP) Appoints Michael Abrams as Chief Financial Officer
Prnewswire· 2024-11-18 21:05
Industry veteran with extensive experience in key areas of focus Interim-CFO Richard Narido to focus on HOPE Therapeutics acquisition opportunities WILMINGTON, Del., Nov. 18, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced it has appointed Michael Abrams as its permanent Chief Financial Officer. Mr. Abrams succeeds Interim-CFO Richard Narido, who will continue to support the Company's financial ...
NRX Pharmaceuticals(NRXP) - 2024 Q3 - Quarterly Results
2024-11-15 22:24
Financial Performance - NRx Pharmaceuticals reduced its net operating loss from $6.1 million in Q3 2023 to $1.6 million in Q3 2024, representing a nearly 75% improvement year over year[27]. - For the nine months ended September 30, 2024, NRx Pharmaceuticals reduced its net loss to $16.1 million compared to $25.8 million in the prior year, reflecting a $9.7 million improvement year over year[28]. - NRx Pharmaceuticals achieved a 54% improvement in net loss per share year over year for the nine months ended September 30, 2024[28]. - HOPE Therapeutics expects to achieve first revenue by year-end 2024, with a 74% reduction in net operating losses compared to Q3 2023 and profitability forecasted in 2025[2]. Research and Development - Research and development expenses decreased from $3.3 million in 2023 to $0.6 million in 2024, primarily due to the conclusion of the phase 2b/3 study for NRX-101[27]. - NRX-100 has shown a highly significant reduction in suicidal ideation in over 500 patients, demonstrating superiority to electroshock therapy in treating depression[3]. - NRX-101 is advancing towards NDA filing based on phase 2b/3 trial data, showing significant reduction in akathisia (P=0.025) and time to sustained remission from suicidality (P=0.05)[4]. - NRx-101 has been designated as an investigational Breakthrough Therapy by the FDA for suicidal treatment-resistant bipolar depression[32]. - NRx Pharmaceuticals has received Fast Track Designation from the FDA for NRX-100, which is intended for treating patients with acute suicidality[33]. Future Plans and Funding - The company plans to file New Drug Applications (NDAs) for NRX-100 and NRX-101 by the end of 2024, with a PDUFA date forecast for 2025[1]. - The company secured $10.8 million in convertible-debt funding to support FDA New Drug Applications for NRX-100 and NRX-101, as well as to retire prior debt[6]. - NRx Pharmaceuticals plans to file New Drug Applications for NRX-100 (ketamine) and NRX-101, which are aimed at treating suicidal depression and chronic pain[33]. - The company is working on retiring historical debt with more favorable terms and a lower annual interest rate through the recent financing[29]. Operational Strategies - The company is implementing operational efficiencies to extend its cash runway while focusing on generating revenue and shareholder value[30]. - As of September 30, 2024, NRx Pharmaceuticals had $1.6 million in cash and cash equivalents, and subsequently closed tranche two of Secured Debt Financing for $5.4 million[29]. - HOPE Therapeutics is building a nationwide network of Interventional Psychiatry Clinics, with plans for a public listing and bond offerings to fund its expansion[23]. - The company is developing a digital therapeutic-enabled platform to enhance the clinical benefits of NMDA-targeted drug therapy[34]. Stakeholder Communication - The company emphasizes the importance of forward-looking statements and the associated risks and uncertainties that may affect future performance[35]. - The company encourages stakeholders to review detailed financials available in their Form 10-Q filed with the SEC[30]. - NRx Pharmaceuticals is focused on expanding its therapeutic offerings for central nervous system disorders, including PTSD and chronic pain[32].
NRx Pharmaceuticals (NASDAQ:NRXP) Reports Third Quarter and Year to Date 2024 Financial Results and Provides Business Update
Prnewswire· 2024-11-14 21:05
NRX-100 (IV Ketamine) safety and efficacy data have been aggregated from clinical trials in more than 500 patients in collaboration with leading US and French Universities that demonstrate a highly significant reduction in suicidal ideation compared to placebo and active comparator. IV ketamine has been shown to be superior (in post-hoc analysis) to electroshock therapy in treating depression. Stability data has now been generated for three manufacturing lots required for NDA filing in suicidal depressio ...
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reschedules Conference Call to Discuss Third Quarter and Year to Date 2024 Financial Results to November 18, 2024
Prnewswire· 2024-11-13 13:03
WILMINGTON, Del., Nov. 13, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will reschedule its third quarter and year to date 2024 results conference call to Monday November 18, 2024 at 4:30pm ET, to accommodate any additional corporate news.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 ...
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Report Third Quarter and Year to Date 2024 Financial Results on November 14, 2024
Prnewswire· 2024-11-07 21:06
WILMINGTON, Del.  , Nov. 7, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its third quarter and year to date 2024 financial results after the market closes on Thursday, November 14, 2024, via press release, which will be available on the Company's website at https://ir.nrxpharma.com/. The Company will host a conference call to discuss the financial results as well as provi ...
HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Signing of a Letter of Intent to Acquire its First Florida Interventional Psychiatry Clinics
Prnewswire· 2024-10-30 11:47
The clinics are located in favorable locations, are revenue generating and EBITDA positive Clinics offer a comprehensive range of mental health services Acquisition is expected to be immediately accretive to revenue and EBITDA for HOPE and NRx MIAMI, Oct. 30, 2024 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), a medical and technology driven company, and a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq: NRXP), today announced signing a non-binding Letter of Intent (L ...