NRx Pharmaceuticals Announce Alignment With FDA On Pediatric Study Plan For NRX-100 (ketamine); Remains On Track To File The NDA For NRX-100 In Q4 2024 With Anticipated PDUFA Date In Q2 2025
Portfolio Pulse from Benzinga Newsdesk
NRx Pharmaceuticals announced alignment with the FDA on the Pediatric Study Plan for NRX-100 (ketamine) aimed at treating suicidal depression in adolescents. The company remains on track to file the NDA for NRX-100 in Q4 2024, with an anticipated PDUFA date in Q2 2025.
July 29, 2024 | 12:46 pm
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NRx Pharmaceuticals has received FDA alignment on its Pediatric Study Plan for NRX-100, a key step towards filing an NDA in Q4 2024. This regulatory progress is crucial for the company's future product pipeline.
The FDA's alignment on the Pediatric Study Plan is a significant regulatory milestone for NRx Pharmaceuticals. This progress keeps the company on track for its NDA filing, which is critical for the future commercialization of NRX-100. Investors are likely to view this as a positive development, potentially boosting the stock price in the short term.
CONFIDENCE 90
IMPORTANCE 80
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