HOPE Therapeutics is now operating three revenue-generating facilities in Florida and expects six or more by year-end providing neuroplastic drugs, transcranial magnetic stimulation, hyperbaric therapy, and digital therapeutics to treat suicidal depression and PTSD.
NRx has secured operating capital anticipated to be sufficient for drug development operations through July 2026. The Company additionally expects to increase revenue from clinical operations.
NRx received FDA grant of Fast Track Designation for NRX-100 in the treatment of suicidal ideation in patients with depression, including bipolar depression.
New Real-World Data support the effect of D-cycloserine (NRX-101 active ingredient) in doubling the effectiveness of Transcranial Magnetic Stimulation (TMS). Company has expanded access program for NRX-101 in augmenting TMS in depression, suicidality, and PTSD.
WILMINGTON, Del., Nov. 17, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals," the "Company"), a clinical-stage biopharmaceutical company, today announced financial results for the quarter ended September 30, 2025, and provided a corporate update.
"In 2025 we have advanced each of our corporate objectives and entered into revenue-generating activity for the first time. For NRX-100 in suicidal depression, we received an expanded Fast Track designation, opened an Expanded Access program and enhanced our regulatory package. Additionally, FDA granted our Suitability Petition for a single patient, preservative free ketamine strength and we have received validation that our ANDA filing is on track with no major deficiencies. In parallel, the Real World Data demonstrating a doubling of antidepressant and antisuicidal effect of Transcranial Magnetic Stimulation (TMS) when D-cycloserine is added creates a new and significant indication for NRX-101 that has potential for approval, if confirmed in an additional phase 3 trial. For HOPE, we continue to execute on building our delivery platform of three active facilities in Florida, with three more planned by year-end. Dr. Rebecca Cohen and LTC Charles Paul, RN (US Army, Ret.) are assembling a network of best-in-class interventional psychiatrists to meet the needs of people, including active duty military, first responders, and veterans, across Florida and beyond," said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals.
Key Research and Development and Corporate ActivitiesNRX-100 (intravenous ketamine)NRx is pursuing two paths to market for NRX-100: a distinct innovative pathway via a New Drug Application (NDA) under FDA Fast Track designation to develop NRX-100 for suicidal ideation in depression, including bipolar depression, and a generic pathway via an Abbreviated New Drug Application (ANDA) to supply a preservative-free ketamine (KETAFREE™) into the existing ketamine market. Recent correspondence from the FDA suggests that the latter pathway is on track for a Q2 2026 GDUFA date. The current generic ketamine market is estimated at approximately $750 million, as previously disclosed. By contrast, the innovative ketamine-based product SPRAVATO® is expected to generate over $1.6 billion in 2025 sales, although its labeling states that effectiveness in preventing suicide or reducing suicidal ideation has not been demonstrated. This highlights a differentiated opportunity for NRX-100, specifically in suicidal ideation.A New Drug Application ("NDA") for NRX-100 for suicidal depression, originally initiated during the fourth quarter of 2024, is expected to be completed in the fourth quarter 2025 with the addition of Real World Efficacy Data drawn from more than 60,000 patients treated for depression with intravenous ketamine compared to 6,000 patients treated with intranasal S-ketamine to be submitted as part of the NDA. An interim analysis drawn from the first 20,000 patients suggests that IV ketamine may have a more rapid onset of action and larger magnitude of effect than nasal S-ketamine. The Company has applied to receive a Commissioner's National Priority Voucher (CNPV), which could significantly reduce review time.
The Abbreviated New Drug Application ("ANDA") for NRX-100 was filed, with Priority Review requested, during the third quarter of 2025. After meeting with the FDA in August 2025, the Company re-filed the ANDA, following FDA notification of approval ...
