Business
NRx Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Business Update
Enrollment continues in the Phase 2b/3 clinical trial evaluating NRX-101 in Suicidal Treatment-Resistant Bipolar Depression; data expected in 4Q 2023National
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Enrollment continues in the Phase 2b/3 clinical trial evaluating NRX-101 in Suicidal Treatment-Resistant Bipolar Depression; data expected in 4Q 2023National educational campaign launched to further accelerate enrollment inBreakthrough Therapy Designation meeting for NRX-101 in Suicidal Treatment-Resistant Bipolar Depression with the U.S. FDA planned for 2Q 2023; on track to report topline clinical data in 4Q 2023Ended quarter with $16.5 million in cash and cash equivalentsManagement to host a conference call and webcast today at 8:30 a.m. ETRADNOR, Pa., May 16, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\", the \"Company\"), a clinical-stage biopharmaceutical company, today announced its financial results for the first quarter of 2023 and provided a business update.\n\"In the U.S. alone, nearly one million people suffer from Suicidal Treatment-Resistant Bipolar Depression, a lethal condition that ultimately leads to a suicide attempt in half of this patient population. Currently, there is no approved medicine for patients with this condition, and the only FDA-approved treatment is electroshock therapy, which has numerous known side-effects,\" said Stephen Willard, J.D., Chief Executive Officer and Director of NRx Pharmaceuticals. \"We are committed to demonstrating the therapeutic benefit of NRX-101, the first oral NMDA-targeted medicine to be developed for patients with suicidal bipolar depression, for these patients facing significant unmet need, and we remain on track to report initial data from this integrated trial in the fourth quarter of this year. We look forward to working with the U.S. FDA on the upgraded Phase 2b/3 trial of NRX-101 in the broader indication of Suicidal Treatment-Resistant Bipolar Depression during a Breakthrough Therapy Designation meeting later this quarter.\"\nFirst Quarter Clinical and Regulatory Highlights\nNRX Pharma is engaged in the development of NRX-101, a fixed dose combination of D-cycloserine and lurasidone for the treatment of suicidal bipolar depression and potentially for other future indications. NRX-101 has been granted Fast Track Designation, Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support by the US Food and Drug Administration (FDA). In Q1 2023 the Company met with the FDA and was guided to e...