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.
HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals (Nasdaq: NRXP), has announced potential acquisition and financing agreements for $30 million in currently-operating interventional psychiatry clinics. Key points include:
1. A $30 million Term Sheet from a qualified lender for non-dilutive financing, expected to close within 60 days.
2. A non-binding Term Sheet with initial clinic partners generating over $10 million in annual revenue.
3. Projected annualized revenues of $100 million through continued acquisitions by mid-2025.
4. Focus on treating suicidal depression, treatment-resistant depression (TRD), and PTSD using ketamine therapy, TMS, and digital therapeutics.
5. Planned operations in the United States, France, and the United Kingdom.
NRx Pharmaceuticals (NASDAQ:NRXP) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Secured $10.8-$16.3 million in convertible-debt funding to support FDA New Drug Applications for NRX-100 (ketamine) and NRX-101.
2. Plans to file NDAs for NRX-100 in suicidal depression and NRX-101 for Accelerated Approval in bipolar depression with akathisia or suicidality.
3. Reduced net loss to $7.9 million in Q2 2024, down from $8.7 million in Q2 2023.
4. Decreased R&D expenses to $2.8 million in Q2 2024 from $3.9 million in Q2 2023.
5. HOPE Therapeutics subsidiary focused on ketamine clinics planned for spinout.
NRx Pharmaceuticals, Inc. (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has announced that it will release its second quarter and year to date 2024 financial results on August 14, 2024, after market close. The results will be available via press release on the company's investor relations website.
Following the release, NRx Pharmaceuticals will host a conference call at 4:30 PM ET on the same day to discuss the financial results and provide a corporate update. Investors can access the call through a live webcast on the company's website or by dialing in using the provided domestic and international phone numbers.
NRx Pharmaceuticals (NASDAQ: NRXP) has secured up to $16 million in convertible debt financing from an institutional investor, Anson Funds. The proceeds will support the 2024 filings for New Drug Applications of NRX-100 (ketamine) and NRX-101, and also aid in launching HOPE Therapeutics. Additionally, a settlement has been reached with Streeterville Capital, who will receive payments from this financing and release all claims.
This financing will come at a significantly lower interest rate and cost of capital compared to previous debts.
NRx Pharmaceuticals (Nasdaq: NRXP) has announced alignment with the FDA on the initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in treating suicidal depression. This alignment is important for the upcoming New Drug Application (NDA) filing, scheduled for Q4 2024. Key points include:
1. FDA recognizes the importance of addressing suicidal depression in adolescents aged 9-17.
2. NRx commits to conducting a clinical trial for NRX-100 in this age group post-adult approval.
3. The company remains on track for NDA filing in Q4 2024, with an anticipated PDUFA date in Q2 2025.
4. Additional neurotoxicity studies in juvenile animals will support safety assessments.
The FDA's feedback highlights the growing crisis of youth suicide in the US, with 10% of high school students attempting suicide in the past year.
NRx Pharmaceuticals (Nasdaq: NRXP) announced a significant legal victory as a Utah arbitrator denied Streeterville Capital's petition to block the planned spinoff of HOPE Therapeutics. This decision allows NRx to proceed with its intention to distribute 49% of HOPE Therapeutics shares to current NRx shareholders, subject to regulatory compliance. The arbitrator also rejected Streeterville's attempt to prevent NRx from selling additional shares for operational funding.
HOPE Therapeutics, a wholly-owned subsidiary of NRx, is developing a network of clinics offering ketamine and other therapies for suicidal depression. The spinoff aims to create value for shareholders and potentially list HOPE Therapeutics on a national securities exchange. Prof. Jonathan Javitt, NRx's Founder and Chairman, expressed gratitude for shareholder support as the company moves forward with its plans.
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has released a Shareholder Update Letter. The update outlines potential paths to revenue and profitability in 2025. Specifically, the company anticipates potential 2024 revenue from HOPE Therapeutics-branded interventional psychiatry clinics and 2025 revenue from sales of NRX-100 (IV Ketamine) and NRX-101, pending FDA approvals. The full letter can be found on the company's website, and interested parties are encouraged to subscribe to future updates via email alerts.
NRx Pharmaceuticals (NASDAQ: NRXP) announced plans to file two New Drug Applications (NDAs) in 2024. The first NDA for NRX-101 targets bipolar depression with akathisia, leveraging two positive trials and a Breakthrough Therapy Designation. The second NDA for NRX-100 (IV ketamine) addresses suicidal depression, backed by four positive trials and a Fast Track Designation. Both drugs could potentially generate significant revenue by 2025, with projected figures exceeding $150 per NRXP share. The company aims to complete the necessary 12-month stability data for both applications in 2024. Additionally, NRx is progressing towards the public listing of HOPE Therapeutics, pending completion of a public audit and SEC Form 10 review.
NRx Pharmaceuticals (Nasdaq: NRXP), a clinical stage pharmaceutical company, announced its participation in the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference on June 27, 2024.
Dr. Jonathan Javitt, Chairman and Chief Scientist, will engage in a fireside chat at 7:00am ET. The event can be accessed via a provided link or the Company's Investor Relations website. Additionally, Dr. Javitt and Matthew Duffy, Chief Business Officer, will conduct one-on-one meetings with investors throughout the day.
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced the appointment of Dr. Dennis McBride to its Board of Directors on June 18, 2024. Dr. McBride brings vast experience in Neuroscience, Medical Technology, and Information Technology. His background includes leadership roles in several prominent national labs and founding initiatives that have become multi-billion-dollar enterprises. Dr. McBride has also developed military-proven digital therapeutic technology for stress and depression reduction. This appointment is expected to leverage his expertise to advance NRx's CNS product pipeline and digital therapeutics initiatives.
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