FDA Endorses NRx Pharmaceuticals' Accelerated Approval & Pediatric Study for Bipolar Depression & Akathisia Treatment : NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP)

WILMINGTON, DELAWARE, UNITED STATE, July 30, 2024 /EINPresswire.com/ -- Alignment with FDA on Pediatric Study Plan and Accelerated Approval to Treat Bipolar Depression and Akathisia: NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)

NRXP could Realize Over $150 in Revenue Per Share, Plus HOPE Subsidiary Spinoff Moves Forward
For more information on $NRXP visit: https://www.nrxpharma.com/ and https://compasslivemedia.com/case-study/nrx-pharmaceuticals/

Developing Therapeutics for the Treatment of CNS Disorders, Specifically Suicidal Bipolar Depression, Chronic Pain and PTSD.

Alignment on Initial Pediatric Study Plan is a Gating Requirement for Upcoming Filing of NRX-100 New Drug Application for Suicidal Depression.

On Track to File NDA for NRX-100 in Q4 2024 & Planned PDUFA Date in Q2 2025.

Petition for Temporary Restraining Order Brought by Streeterville Capital, LLC to Prevent Spinoff of HOPE Therapeutics to NRXP Shareholders Denied.

New Drug Application (NDA) for Accelerated Approval Planned for People with Bipolar Depression and Akathisia in 2024 with Potential Revenue in 2025.

NDA for NRX-100 (IV ketamine) for Suicidal Depression in Advanced Preparation for 2024. with Potential Revenue in 2025.

Gaining Approvals Could Yield More Than $150 in Revenue per NRXP Share in the Near Term at Current Share Count.

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain

NRXP has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.

NRXP is working on a New Drug Application for NRX-100 (IV ketamine) in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRXP was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.

Alignment with FDA on Pediatric Study Plan for NRX-100 (ketamine)

On July 29th NRXP announced a communication from the US Food and Drug Administration (FDA) providing feedback and alignment on the Company’s proposed initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in the treatment of suicidal depression. Congress required the submission of an iPSP as a precondition to filing a New Drug Application in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).

In support of its upcoming NDA filing, NRXP will be submitting existing data supporting the safety and efficacy of ketamine to treat suicidal depression in adults. FDA has now documented its recognition that suicide is a serious and growing public health concern in adolescents as well. Based on the guidance received, NRXP will commit to conducting a clinical trial of NRX-100 in adolescents aged 9-17 with suicidal depression, but will not be required to study the effects of NRX-100 in younger age groups, following initial approval of NRX-100 in adults. Additional neurotoxicity studies will be conducted to support the safety of intravenous ketamine in this younger population.

Arbitration Order Enabling HOPE Therapeutics Spinoff


On July 29th NRXP announced an order of the Utah arbitrator denying the petition of Streeterville Capital, LLC to enjoin the planned spinoff of 49% of shares in HOPE Therapeutics to current shareholders of NRXP. The purpose of this spinoff was both to provide NRXP shareholders with valuable consideration and to provide HOPE Therapeutics (currently a wholly-owned subsidiary of NRXP) with a sufficient shareholder base to enable future listing on a public securities exchange. The arbitrator also denied Streeterville’s petition to enjoin NRXP from selling additional shares of NRXP stock to finance ongoing operations.

“As we have previously shared with the public, HOPE Therapeutics is in the process of developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression. This arbitration decision enables us to keep our promise to shareholders to spin out up to 49% of HOPE Therapeutics shares held by NRXP to NRXP shareholders as of an ex-dividend date to be announced, subject to approval of a Form 10 filing by the US Securities and Exchange Commission and approval of the NRx Board of Directors. We appreciate the support and loyalty of our shareholders as we work to bring HOPE to life,” said Prof. Jonathan Javitt, Founder and Chairman of NRXP and Co-CEO of HOPE Therapeutics.

July Shareholder Update Letter

On July 1st NRXP announced a new Shareholder Update Letter has been posted on its website via this link: NRx Shareholder Update (https://www.nrxpharma.com/management-answers-to-shareholder-questions/). This detailed update covers the company’s potential paths to revenue and profitability in 2025 and all of the latest and most important company developments. NRXP further invites interested parties to subscribe to their email alert service to stay up to date on company's progress.


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Matthew Duffy, Chief Business Officer
NRx Pharmaceuticals, Inc.
484-254-6134
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