NRx Pharmaceuticals Q2: FDA Ketamine Review Clears Major Hurdle, Cash Runway Extended to One Year
NRXP has more than doubled off its 52-week low of $1.62.
Summary
NRx Pharmaceuticals reported Q2 2026 results with a $16.5 million net loss, but the key development is regulatory: the FDA completed its first-cycle review of the ANDA for preservative-free ketamine with no drug-related major deficiencies. The sole remaining item—a manufacturer's attestation on the vial—has been submitted, positioning the company for potential 2026 approval and commercialization. The company has initiated commercial-scale manufacturing with 5 million doses of launch stock in process. Cash from the June $22.3 million offering is expected to fund operations for at least one year. Additional updates include DARPA selection for the SPARC-TMS Phase 2/3 trial with over $11.5 million in non-dilutive funding, advancement of the NRX-100 NDA using Real World Evidence from 65,000 patients, expansion of HOPE Therapeutics clinical sites, and appointment of a Chief Commercial Officer. This follows the 10-Q filed August 14th and adds operational detail on manufacturing readiness and regulatory progress. The conference call is scheduled for today at 4:30pm ET.
At the time of this announcement, NRXP was trading at $3.25 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $137.2M. 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 7 out of 10. Source: GlobeNewswire.