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RADNOR, Pa., Dec. 11, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced the Company will be participating in-person at the LifeSci Partners Corporate Access Event for three days from January 8th through the 10th in San Francisco.
2024 promises to be a year of substantial growth that will likely include the filing of the Company's first New Drug Application. The company welcomes the opportunity to update investors on its extraordinary recent progress, upcoming clinical and regulatory catalysts, and to answer questions.
Sign-up: LifeSci Partners Corporate Access Event 2024
NRx currently has four (4) near-term shots on goal with meaningful commercial and/or monetization opportunities:
NRX-100 – Intravenous Ketamine. With recent failures in in attempts to develop nasal ketamine, NRx has the only potential near-term path through the FDA for a labeled ketamine product that will address the needs of patients with both bipolar and unipolar depression. In March 2024, we aim to submit a New Drug Application based on data from two well-controlled, randomized trials together with GMP manufacturing data, aiming for two-year stability at launch. NRx has incorporated HOPE Therapeutics. Inc. as a vehicle for taking ketamine to market. We are developing this as a spinout that will focus on current income for investors in a market that could be accessed by the end of 2024; we will discuss HOPE financing options with investors as well.
NRX-101 – Treatment-Resistant Bipolar Depression. Phase 2b/3 trial enrollment is nearing completion with data expected in early 2024. NRx has partnered this program with Alvogen, with $330 million in potential milestones and a 15% royalty, including a $10 million milestone payment on successful data readout and FDA comment; Alvogen is responsible for all development and commercialization costs, following receipt of positive data and FDA response.
NRX-101 – Chronic Pain. D-cycloserine (DCS) has been shown to reduce nociceptive pain (~$70b market opportunity) while demonstrating no potential for addiction and potentially reducing opioid craving. With data readout from a larger U.S. DoD-funded study evaluating DCS in chronic, refractory low back pain expected imminently, the company has submitted NRX-101 for HEAL funding from NIH.
NRX-101 – Complicated Urinary Tract Infection. While 90% of organisms show resistance to common antibiotics, data show that DCS is effective against many of these pathogens and is highly concentrated in the urine. NRx has submitted an IND and is eligible for FDA Qualified Infectious Disease Product status; response is expected shortly. The company is exploring spin-out or licensing opportunities.
NRx will be hosting 1x1 meetings at the Beacon Grand Hotel (450 Powell Street, a block away from the JP Morgan Conference at Union Square). To schedule a meeting, please register at LifeSci Partners Corporate Access Event 2024 and request a meeting with management.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain.
NRx has recently announced plans to submit a New Drug Application for ketamine in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
SOURCE NRx Pharmaceuticals, Inc.
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