NRx Pharma, HOPE Therapeutics Align With FDA On Pediatric Study Plan For NRX-100

July 29, 2024 — 11:00 am EDT

Written by RTTNews.com for RTTNews

(RTTNews) - NRx Pharmaceuticals, Inc. (NRXP), Monday announced that along with HOPE Therapeutics, Inc., the company would align with the U.S. Food and Drug Administration on an initial Pediatric Study Plan for NRX-100 for the treatment of suicidal depression in adolescents aged 9 to 17.

The announcement comes as the company has received FDA's feedback and alignment on the proposed iPSP, which is a requirement for filing a New Drug Application.

The company would also conduct additional neurotoxicity studies in juvenile animals to support safety of intravenous ketamine.

NRx said it is on track to file the NDA for NRX-100 in the fourth quarter of 2024, with an anticipated PDUFA date in the second quarter of 2025.

Currently, NRx Pharma's stock is climbing 2.07 percent, to $2.46 on the Nasdaq.

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NRx Pharma, HOPE Therapeutics Align With FDA On Pediatric Study Plan For NRX-100

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