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Posted On: 11/17/2025 3:56:52 PM
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NetworkNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Reports Q3 Results and Advances NRX-100 and NRX-101 Regulatory Programs
NRx Pharmaceuticals (NASDAQ: NRXP) reported third-quarter 2025 results and outlined progress across its clinical programs, noting its first revenue-generating activities and key regulatory milestones for NRX-100 and NRX-101. The Company highlighted expanded Fast Track status and an active Expanded Access program for NRX-100 in suicidal depression, continued advancement of its NDA supported by large-scale real-world ketamine data, and an ANDA pathway for its preservative-free ketamine KETAFREE that remains on track for a Q2 2026 GDUFA date. NRx also noted FDA communication with no major deficiencies in its revised ANDA filing and ongoing efforts to remove benzethonium chloride from commercial ketamine formulations. For NRX-101, the Company initiated its NDA with Breakthrough Therapy Designation and rolling review, supported by real-world evidence showing that D-cycloserine more than doubles the antidepressant and antisuicidal effect of TMS. A confirmatory phase 3 trial is slated for early 2026, and the Company continues expanding its HOPE delivery platform with additional facilities planned in Florida.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://nnw.fm/NRXP
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
NRx Pharmaceuticals (NASDAQ: NRXP) reported third-quarter 2025 results and outlined progress across its clinical programs, noting its first revenue-generating activities and key regulatory milestones for NRX-100 and NRX-101. The Company highlighted expanded Fast Track status and an active Expanded Access program for NRX-100 in suicidal depression, continued advancement of its NDA supported by large-scale real-world ketamine data, and an ANDA pathway for its preservative-free ketamine KETAFREE that remains on track for a Q2 2026 GDUFA date. NRx also noted FDA communication with no major deficiencies in its revised ANDA filing and ongoing efforts to remove benzethonium chloride from commercial ketamine formulations. For NRX-101, the Company initiated its NDA with Breakthrough Therapy Designation and rolling review, supported by real-world evidence showing that D-cycloserine more than doubles the antidepressant and antisuicidal effect of TMS. A confirmatory phase 3 trial is slated for early 2026, and the Company continues expanding its HOPE delivery platform with additional facilities planned in Florida.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://nnw.fm/NRXP
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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