FDA Approves NRx's Preservative-Free Ketamine Weeks Ahead of Goal Date
NRXP sits 84% above its 52-week low of $1.62 on elevated volume (2.0× avg).
Summary
The FDA approved NRx's ANDA for preservative-free ketamine, clearing the way for the company to start selling into US hospitals and clinics. The approval landed ahead of the November 10 GDUFA goal date, and management says commercial supply is already manufactured and ready to label. This is the first revenue-generating product for a company that has been running on ATM raises and a going-concern warning — Q2 alone showed a $16.5 million net loss. The pitch is a shortage market: ketamine injection has been on the FDA shortage list since 2018, and NRx argues the benzethonium chloride preservative in existing products is no longer acceptable to the agency. It follows the September 16 8-K that moved the ANDA amendment from Major to Minor and set the goal date, and the October 15 Discipline Review Letter that asked only for minor label changes. The company hosts a call at 8:30 a.m. ET today to discuss the approval.
At the time of this announcement, NRXP was trading at $2.98 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $115.2M. The 52-week trading range was $1.62 to $5.06. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.