NRX Pharmaceuticals

At the Cantor conference, NRx Pharmaceuticals presented an integrated strategy combining drugs (KETAFREE, NRX-100, NRX-101), clinic operations (HOPE Therapeutics) and robot-assisted TMS technology. KETAFREE, a preservative-free ketamine, is the near-term focus; the company expects an FDA decision in mid‑October 2024 and aims for a market launch and profitability by mid‑2025. NRX-100 is intended to gain approval for depression and suicidality using real‑world evidence, while NRX-101 will be developed long-term in combination with TMS. NRx highlights supply stability as a competitive advantage, sees large market potential for ketamine-based therapies, but remains dependent on FDA rulings, reimbursement and execution. » More on de.investing.com

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. » More on 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. » More on de.investing.com