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NRX Pharmaceuticals Gains FDA Fast Track for NRX-100

Story Highlights
  • NRx Pharmaceuticals received FDA Fast Track designation for NRX-100, expanding its addressable population.
  • FDA identified deficiencies in NRx’s ANDA application, which the company plans to address and resubmit.
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NRX Pharmaceuticals Gains FDA Fast Track for NRX-100

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NRX Pharmaceuticals ( (NRXP) ) just unveiled an update.

On August 11, 2025, NRx Pharmaceuticals announced that the FDA granted Fast Track designation to NRX-100 for treating suicidal ideation in patients with depression, including bipolar depression. This designation significantly expands the addressable population for NRX-100 and acknowledges its potential to meet an unmet medical need. However, the FDA identified deficiencies in NRx’s ANDA application for NRX-100, requiring the company to address missing manufacturing batch records and a quantitative difference in an inactive ingredient. NRx plans to remedy these issues and resubmit the application, viewing the FDA’s feedback as part of the standard regulatory process.

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 is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal depression, chronic pain, and PTSD. The company is advancing NRX-100, a preservative-free intravenous ketamine, and NRX-101, an oral D-cycloserine/lurasidone, with NRX-100 receiving Fast Track Designation for treating suicidal ideation in depression, including bipolar depression.

Average Trading Volume: 274,920

Technical Sentiment Signal: Sell

Current Market Cap: $52.07M

Learn more about NRXP stock on TipRanks’ Stock Analysis page.

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