RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) recently announced plans to file two New Drug Applications (NDAs) in 2024. The filings, supported by advice from regulatory counsel including former senior FDA officials, aim for Accelerated Approval for NRX-101 to treat bipolar depression in patients with akathisia and for approval of NRX-100 (IV ketamine) for treating suicidal depression.
While the company has gathered efficacy and safety data, filing these applications depends on completing 12-month stability data for manufactured lots, as required by the FDA.
NRx will file the NRX-101 application without a commercial partner. The addressable market for this indication allows for a compact and efficient sales force, manageable by a small company like NRx. Current executives at NRx have experience launching similar-sized pharmaceutical assets.
The company is also working on distributing shares in Hope Therapeutics. This distribution hinges on completing a public audit and a successful review of an SEC Form 10.
“The NRx team has worked diligently since the end of the COVID pandemic to achieve these milestones for our shareholders and most importantly the patients we have always sought to help,” said Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx. “Given the near-term market opportunity represented by an accelerated approval process, NRx anticipates a higher potential return to NRx investors associated with an NRx-led initiative than that which would likely be achieved with a large commercial partner.”
NRx’s strategy reflects its commitment to advancing treatments for serious mental health conditions while aiming to maximize returns for its investors.
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