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.
At a glance
- Company
- NRx Pharmaceuticals, Inc.
- Ticker
- NASDAQ: NRXP
- Announcement
- Earnings
Products and programs
To view the full press release, visit https://ibn.fm/XfuD3
About NRx Pharmaceuticals, Inc.
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 Suicidal Ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal depression.
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In brief
NRx Pharmaceuticals reported third-quarter 2025 results and described regulatory and clinical progress across its programs. The company says NRX-100 has expanded Fast Track status and an active Expanded Access program for suicidal depression, with its NDA advancing using real-world ketamine data. Its preservative-free ketamine product KETAFREE remains on an ANDA pathway, with a Q2 2026 GDUFA date; the company also reported FDA communication identifying no major deficiencies in its revised filing. For NRX-101, NRx says it has initiated an NDA with Breakthrough Therapy Designation and rolling review, supported by real-world evidence on D-cycloserine and TMS. A confirmatory phase 3 trial is planned for early 2026. The company also reported first revenue-generating activities and plans to add facilities in Florida for its HOPE delivery platform.
Key takeaways
- NRx reported third-quarter 2025 results and its first revenue-generating activities.
- NRX-100 has expanded Fast Track status and an active Expanded Access program, according to the company.
- KETAFREE’s ANDA pathway remains on track for a Q2 2026 GDUFA date.
- NRx initiated an NDA for NRX-101 with Breakthrough Therapy Designation and rolling review.
- A confirmatory phase 3 trial for NRX-101 is planned for early 2026.
