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NRx Pharmaceuticals (NRXP) Reports Q3 Results and Advances NRX-100 and NRX-101 Regulatory Programs

LOS ANGELES, CA - November 17, 2025 (NEWMEDIAWIRE) - 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 mileston...

articleNrx Pharmaceuticals, Inc.November 17, 20253/company/nrx-pharmaceuticals-inc/news/nrx-pharmaceuticals-nrxp-reports-q3-results-and-advances-nrx-100-and-nrx-101-regulatory-programs
NRx Pharmaceuticals (NRXP) Reports Q3 Results and Advances NRX-100 and NRX-101 Regulatory Programs

About this update from Nrx Pharmaceuticals, Inc.

[{"type":"text","content":"LOS ANGELES, CA - November 17, 2025 (NEWMEDIAWIRE) - 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.","length":1171,"tagName":"p"},{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":"Investor Brand Network","className":"","disableSlideshowImg":false,"size":{"original":{"width":610,"height":520,"url":"https://media.zenfs.com/en/newsmediawire_165/d8af5ae9288c0f70ceb08aa9713a28cf"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/kpD0NvVnaK_aNpdu.cQQ2w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTgxODtjZj13ZWJw/https://media.zenfs.com/en/newsmediawire_165/d8af5ae9288c0f70ceb08aa9713a28cf","width":610,"height":520}}},{"type":"text","content":"To view the full press release, visit https://ibn.fm/XfuD3","length":58,"tagName":"p"},{"type":"text","content":"About NRx Pharmaceuticals, Inc.","length":31,"tagName":"p"},{"type":"text","content":"NRx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suic...

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