NRX Pharmaceuticals

The FDA has completed the first review cycle of the ANDA for NRx Pharmaceuticals’ preservative-free ketamine and found no material deficiencies in active ingredient, labeling, manufacturing or safety data. One remaining material issue concerns the manufacturer certification of the vial’s Luer-lock tip; the FDA is requesting confirmations that it is produced on the same lines and has been used without prior objections. NRx held a clarification meeting with the FDA, submitted test data for more than 3,500 vials and plans to promptly provide the requested certifications; the FDA review will be conducted in the shortest possible cycle. The company will provide an update on the approval process and commercialization preparations on an August 10 conference call. » Altro su de.investing.com

An analysis of electronic health records (8,224 patients treated with intravenous ketamine vs. 1,830 with intranasal esketamine) found that 34% of ketamine patients achieved remission vs. 26% for esketamine; response rates were 63% vs. 58%. Intravenous ketamine was statistically significantly associated with about a 22% higher likelihood of response and roughly a 50% higher likelihood of remission. The study is non-randomized and is based on patients from clinics that use the Osmind EHR; NRx is developing preservative-free intravenous NRX-100 and has filed or initiated regulatory dossiers. » Altro su de.investing.com

NRx Pharmaceuticals sold common shares at $3.50 each, generating gross proceeds of approximately $22.3 million, including the exercise of the overallotment option. Net proceeds are intended for working capital and general corporate purposes; the stock currently trades at $4.05, above the offering price. Analysts point to short-term liquidity constraints as the company continues to advance its clinical pipeline around NRX-100 (intravenous ketamine) and NRX-101 (oral combination treatment). » Altro su de.investing.com