An Executive Informational Overview (EIO) is now available on NRx Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing novel therapeutics for the treatment of central nervous system disorders with high unmet medical needs, specifically suicidal depression and post-traumatic stress disorder (PTSD). The 66-page report details the Company's business, its strategy, market opportunities, competition, financials, risks, and more. It is available for download below.
Snapshot
NRx Pharmaceuticals, Inc. (“NRx” or “the Company”) is a clinical stage biopharmaceutical company developing novel therapeutics for the treatment of central nervous system disorders with high unmet medical needs. The Company’s foundation product is NRX-101, a patented combination of two FDA-approved drugs—D-cycloserine (DCS), an NMDA receptor modulator; and lurasidone, an atypical antipsychotic medication. The Company is assessing the use of NRX-101 in four different indications: suicidal bipolar depression, chronic pain, post-traumatic stress disorder (PTSD), and complicated urinary tract infections (cUTI). Development of NMDA antagonists, such as DCS, as antidepressants has been limited by their potential psychedelic side effects. Furthermore, serotonin-targeted drugs like lurasidone have been limited by their own behavioral side effects, specifically akathisia. Professor Daniel Javitt (NRx Co-founder and Chair of its Scientific Advisory) made the simultaneous discovery that: (1) the psychedelic effects of NMDA antagonist drugs could be reversed by combining them with serotonin-targeted compounds; and (2) NMDA inhibitors, in turn, block the akathisia side effect normally associated with serotonin-targeted drugs. The previously undiscovered synergy between these two drug classes is the subject of 48 issued patents and 43 pending patents owned by or licensed to NRx Pharmaceuticals, and as such, is the medical and scientific basis for the Company’s technology platform.
Key Points of NRx Pharmaceuticals, Inc.
- NRx entered into a collaboration with Alvogen Pharmaceuticals for the development and commercialization of NRX-101 in suicidal bipolar depression, with the potential for up to $330 million in milestones and double-digit royalties.
- The Company is conducting a single Phase 2b/3 trial of NRX-101 for Suicidal Treatment Resistant Bipolar Depression (S-TRBD), with topline clinical data readout expected by Q1 2024, potentially followed by an NDA application shortly thereafter.
- Under the Alvogen agreement, a successful data readout and completion of a Type B meeting with the FDA would trigger a $10 million payment to NRx, at which point, Alvogen would be responsible for all future development and commercialization costs for this indication.
- NRX-101 is also being evaluated for the treatment of chronic pain as a non-addictive substitute for opioid products. The Company is planning to start a pharmacokinetic study following result readout of a 200-person U.S. Department of Defense-funded trial in treating chronic pain with DCS.
- NRx is assessing plans to create spinoff companies to complete development of NRX-100 (IV ketamine) for acute suicidality and NRX-101 for cUTI, which would potentially provide investors with both capital appreciation and a royalty stream.
- As of September 30, 2023, NRx’s cash and cash equivalent position was $8.9 million.
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