NRx completes first-cycle FDA review of ketamine ANDA; no major drug deficiencies

The ANDA for preservative-free ketamine has completed first-cycle FDA review with no drug-related major deficiencies; the sole remaining item (manufacturer attestation on vial) has been submitted. The company is now manufacturing 5 million doses of launch stock and targets 2026 approval and commercialization.

Key facts

Filed: Aug 17, 2026, 12:00 PM
Event: Other
Direction: Positive
Company: NRXPNRX Pharmaceuticals
Asset: ketamine
Source: SEC 8-K
Confidence: Sourced
funding: exceeds $11.5 million
proceeds: $22.3 million
launch stock: 5 million doses

Source excerpt

EX-99.1 2 ex_1005774.htm EXHIBIT 99.1 ex_1005774.htm Exhibit 99.1 NRx Pharmaceuticals (Nasdaq:NRXP) Reports Second Quarter 2026 Financial Results and Provides Corporate Update; Conference Call to be Held on Monday, August 17 th at 4:30pm ET Key recent and second quarter highlights include: ● Completed first-cycle FDA review of the Company’s 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 to FDA. ● Initiation of commercial scale manufacturing of preservative-free ketamine building to launch stock of 5 million doses to be ready for commercialization in 2026. ● Selected by the Defense Advanced Research Projects Agency (DARPA) as prime contractor for SPARC-TMS, an FDA-approved Phase 2/3 trial of NRX-101 with robotic TMS. Anticipated non-dilutive funding exceeds $11.5 million, subject to completion of contracting ● The Company is advancing its NRX-100 NDA on Real World Evidence from more than 65,000 patients, leveraging a Presidential Executive Order and Congressional budget language that encourage FDA use of such evidence in approving treatments for depression. ● Closed an institutionally-supported, underwritten public offering of common stock for gross proceeds of $22.3 million, including full exercise of the underwriters’ option. The Company expects existing cash to fund operations for at least one year. ● HOPE Therapeutics expanded its clinical footprint

SEC 8-K