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.
Relief Therapeutics Holding SA and NRx Pharmaceuticals have reached settlement agreements to resolve litigation. Within the next 30 days, NRx will transfer assets used in aviptadil development to Relief. Relief will gain exclusive rights to develop and commercialize aviptadil while continuing the Right to Try Program for two years. They will pay NRx milestone payments for successful product approvals and royalties up to $30 million based on sales. NRx will refrain from future competition in aviptadil development. The success of aviptadil commercialization is uncertain.
NRx Pharmaceuticals announced that it will report its third quarter 2022 financial results on November 14, 2022, before the market opens. A conference call and webcast will take place at 8:00 AM ET on the same day to discuss the results and provide updates on clinical and corporate matters. Interested participants can access the call via telephone or through a live webcast on the company's website. The company is known for its lead program, NRX-101, which targets bipolar depression and has received regulatory designations aimed at expediting its development.
NRx Pharmaceuticals has transitioned to U.S.-based manufacturing for its investigational drug NRX-101, targeting suicidal bipolar depression. The FDA has received updated manufacturing files, facilitating an upcoming Phase 3 trial aimed at patients with acute suicidal ideation. The drug, a combination of D-cycloserine and lurasidone, has been shown to significantly reduce both depression and suicidality in previous trials. This new capability could expedite the drug's market launch while addressing a critical unmet need in mental health care.
NRx Pharmaceuticals (Nasdaq: NRXP) has secured approximately $11 million in unsecured debt financing from Streeterville Capital, aimed to boost the development of its lead drug NRX-101 for treating suicidal bipolar depression and PTSD. With about $10 million earmarked for these programs, the funds will also support corporate operations. The financing comes with a 9% interest rate and a maturity of 18 months. The company is optimistic about the potential of NRX-101, especially after achieving FDA milestones including Breakthrough Therapy Designation.
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced that CEO Stephen Willard and executives will provide a corporate update at the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 9:00 AM ET. This presentation will cover the company’s progress, particularly focusing on NRX-101, a novel treatment for severe bipolar depression. NRX-101 has received FDA Breakthrough Therapy designation and is expected to begin its registration trial in Q4 2022. The event is accessible via webcast with a replay available for 30 days.
NRx Pharmaceuticals (Nasdaq: NRXP) hosted its Q2 2022 earnings call on August 15, 2022, announcing financial results and clinical updates. The company is focused on its lead compound NRX-101, which has received Breakthrough Therapy designation from the FDA for severe bipolar depression with acute suicidal ideation. A Phase 2 trial for NRX-101 has commenced, aiming for data readout by early 2023. Q2 2022 net loss was $7.0 million, an increase from $0.1 million in Q2 2021, while cash reserves decreased to $24.5 million. The company plans to maintain operations through August 2023.
NRx Pharmaceuticals, based in Radnor, PA, will announce its second quarter 2022 financial results on August 15, 2022, before market open. A conference call will follow at 8:30 AM ET, offering a corporate and clinical update along with a Q&A session. Investors can submit questions via email by 4:00 PM ET on August 12. The call can be accessed by dialing (844) 826-3033 (U.S.) or (412) 317-5185 (International) and the replay will be available on the company's website afterwards.
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) appointed Stephen Willard as CEO and Board member, succeeding interim CEO Robert Besthof, who returns to his previous roles. Willard, a veteran in biotechnology management, previously led Cellphire Therapeutics and Flamel Technologies. His expertise includes law and finance, and he’s a National Science Board appointee (2018-2024). Under Willard’s leadership, NRx aims to advance NRX-101, a promising treatment for bipolar depression and acute suicidal ideation, with plans for FDA registration trials.
NRx Pharmaceuticals announced that the FDA has declined to issue an Emergency Use Authorization for ZYESAMI® (aviptadil) for a subgroup of critically ill COVID-19 patients who were also treated with Remdesivir. This decision follows the previously communicated futility of the ACTIV-3b / TESICO Study. The company will now focus on the development of NRX-101, a treatment for bipolar depression with suicidality. Despite the setback with ZYESAMI®, NRX-101 has received Breakthrough Therapy designation from the FDA, indicating ongoing potential for future development.
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