NRx PharmaceuticalsNASDAQ: NRXP

Potential paths to revenue and profitability in 2025 RADNOR, Pa. , July 1, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company posted a new Shareholder Update Letter on its website NRx Shareholder Update and further invites interested parties to subscribe to their email alert service to stay up to date on company's progress here: NRx Email Alerts.

New Drug Application (NDA) for Accelerated Approval planned for NRX-101 in people with bipolar depression and akathisia in 2024, based on two positive trials 1 2 and Breakthrough Therapy Designation. Potential revenue in 2025 NDA for NRX-100 (IV ketamine) in suicidal depression in advanced preparation for submission in 2024; based on four positive trials 3 4 5 6 and Fast Track Designation.

The June 2024 meeting of the American Society for Clinical Psychopharmacology (ASCP) focused heavily on increasing use of intravenous ketamine and intranasal S-ketamine as the emerging standard of care for treating severe depression and suicidality Presenters from 3 open label studies at the ASCP suggested that intravenous ketamine is at least equivalent and may have advantages over intranasal S-ketamine NRx Pharmaceuticals has now reached the 9-month stability point with its ketamine formulation (NRX-100) and has initiated 3 manufacturing lots for future drug release. Nonclinical safety for short term use of NRX-100 has recently been published and submitted to FDA FDA leadership, in public comments at ASCP, focused on the need for nonclinical safety data for intravenous ketamine as a condition of ketamine approval The short-term need for intravenous ketamine as an already-approved, schedule 3 drug, is heightened by recent regulatory decisions that may delay the path of potent, schedule 1 psychedelic drugs that may require more complicated clinical trial designs.

Poster presentation of "A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior" NRX-101 demonstrated a similar antidepressant effect (MADRS reduction ~50%) compared to lurasidone, the Standard of Care drug NRX-101 demonstrated a 58% relative reduction in time to sustained remission from suicidality (P=.05) compared to lurasidone NRX-101 demonstrated a 76% reduction in symptoms of akathisia (p=0.03), a side effect linked to suicide, compared to lurasidone This represents the second trial of NRX-101 demonstrating reduction in suicidality and akathisia associated with NRX-101 compared to lurasidone RADNOR, Pa. , May 28, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx", the "Company"), a clinical stage pharmaceutical company, today announced presentation of its Phase 2b/3 trial of NRX-101, entitled  "A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior" at the American Society of Clinical Psychopharmacology (ASCP) in Miami Beach, FL.

NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Q1 2024 Results Conference Call will take place on May 14, 2024 at 4:30 PM ET. Presenting will be Matthew Duffy, the Chief Business Officer, Stephen Willard, the Chief Executive Officer, Jonathan Javitt, the Founder, Chairman, and Chief Scientist, and Richard Narido, the Chief Financial Officer and Treasurer. Conference Call Participants include Tim Moore from EF Hutton and Ed Woo from Ascendiant Capital. The operator will provide instructions during the call.

On the most recent trading day, NRx Pharmaceuticals, Inc. (NRXP) ended at $3.14, marking a 0.64% increase from the day before.

NRx Pharmaceuticals, Inc. (NRXP) ended the latest trading session at $3.04, showing a slight increase of +0.66% compared to the day before.

NRx Pharmaceuticals (NRXP) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #1 (Strong Buy).

NRX Pharmaceuticals, Inc. (NRXP) Q4 2023 Earnings Call Transcript