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NRX Pharmaceuticals Submits FDA Application for NRX-100

Story Highlights
  • NRx Pharmaceuticals submitted an ANDA for preservative-free IV ketamine to the FDA.
  • The company aims to address the ketamine shortage and capture market share with a safer formulation.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
NRX Pharmaceuticals Submits FDA Application for NRX-100

Confident Investing Starts Here:

An announcement from NRX Pharmaceuticals ( (NRXP) ) is now available.

On June 5, 2025, NRx Pharmaceuticals announced the submission of its Abbreviated New Drug Application for NRX-100, a preservative-free IV ketamine, to the FDA. This move aims to address the current US ketamine shortage and aligns with efforts to eliminate toxic preservatives. The company seeks priority review due to the shortage and plans to file a petition to remove benzethonium chloride from ketamine products. With the ketamine market projected to grow significantly, NRx aims to capture a substantial share by offering a safer alternative to existing formulations.

The most recent analyst rating on (NRXP) stock is a Buy with a $19.00 price target. To see the full list of analyst forecasts on NRX Pharmaceuticals stock, see the NRXP Stock Forecast page.

Spark’s Take on NRXP Stock

According to Spark, TipRanks’ AI Analyst, NRXP is a Neutral.

NRX Pharmaceuticals is navigating significant financial hurdles with net losses and negative equity, typical for early-stage biotech firms. However, strategic initiatives and drug development progress provide potential upside. Technical analysis and valuation reflect speculative potential, with the stock currently exhibiting mixed technical signals. The positive outlook from the earnings call highlights strategic moves that could improve the company’s financial health if successful.

To see Spark’s full report on NRXP stock, click here.

More about NRX Pharmaceuticals

NRx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD. The company is advancing its NMDA platform, with products like NRX-101, an FDA-designated investigational Breakthrough Therapy, and NRX-100, a preservative-free IV ketamine formulation.

Average Trading Volume: 230,780

Technical Sentiment Signal: Hold

Current Market Cap: $56.54M

For detailed information about NRXP stock, go to TipRanks’ Stock Analysis page.

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