NRx Pharmaceuticals Receives FDA Labeling Review Letter for Ketamine

Key Facts

1NRx Pharmaceuticals received an FDA labeling review letter for its preservative-free ketamine formulation.

2The FDA classified all requested labeling changes as 'MINOR' ahead of the November 10, 2026, GDUFA goal date.

NRx Pharmaceuticals received a labeling review letter from the US Food and Drug Administration (FDA) regarding its preservative-free ketamine formulation. GlobeNewswire reported that the FDA classified all requested labeling changes as "MINOR" ahead of the GDUFA goal date set for November 10, 2026.

NRXP closed at $2.59 on October 14, 2026, with the stock trading between a day low of $2.56 and a high of $2.71 during that session. This regulatory update is part of the ongoing review process for the drug application, reducing uncertainty regarding the path toward potential approval by the November deadline.