HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Alignment with FDA on Pediatric Study Plan for NRX-100 (ketamine)
NRXPNRX Pharmaceuticals(NRXP) Prnewswire·2024-07-29 20:35

FDA response highlights the importance of addressing suicidal depression in adolescents age 9-17Alignment on initial Pediatric Study Plan (iPSP) is a gating requirement for the upcoming filing of an NRX-100 New Drug Application (NDA) for suicidal depressionNRx remains on track to file the NDA for NRX-100 in Q4 2024 with anticipated PDUFA date in Q2 2025RADNOR, Pa., July 29, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical c ...