NRx Pharmaceuticals (Nasdaq:NRXP) Confirms Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting [Yahoo! Fin...
NRX Pharmaceuticals, Inc. (NRXP)
Company Research
Source: Yahoo! Finance
Psychiatry, FDA Office of Neuroscience, and FDA Center for Drug Evaluation and Research. Minutes are consistent with previously announced oral guidance outlining a path to New Drug Approval of NRX-100 for a broadened indication of treating depression, including patients with suicidality. FDA confirmed willingness to review existing Adequate and Well Controlled Clinical Trial data as Substantial Evidence of Efficacy together with Real World Evidence from Osmind, Inc. as confirmatory evidence of efficacy. No additional clinical trials were requested. Company intends to sumbit its New Drug Application for NRX-100 by June 2026. WILMINGTON, Del., March 16, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has received confirmatory minutes from an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration. The meeting was attended by leaders of the FDA Division of
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NRXP
News
- InvestorNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Files 2025 Form 10-K And Highlights Operational Progress [TheStreet.com]TheStreet.com
- NRX Pharmaceuticals Inc (NRXP) Q4 2025 Earnings Call Highlights: Strategic Advances and ... [Yahoo! Finance]Yahoo! Finance
- NRx Pharmaceuticals (NRXP) had its "buy" rating reaffirmed by D. Boral Capital. They now have a $34.00 price target on the stock.MarketBeat
- NRx Pharmaceuticals (NRXP) had its "buy" rating reaffirmed by BTIG Research. They now have a $25.00 price target on the stock.MarketBeat
- NRx Pharmaceuticals, Inc. (NRXP) Q4 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
NRXP
Earnings
- 11/14/25 - Miss
NRXP
Sec Filings
- 3/24/26 - Form 8-K
- 3/23/26 - Form 10-K
- 2/24/26 - Form DEFA14A
- NRXP's page on the SEC website