Trending...
- Grok Wrote a Direct Message to Elon Musk Discussing Netverse & Phinge CEOs Challenge to Live Debate & Added "it'd be epic to see you two hash it out"
- Dr. Frederic Scheer to Speak at Big Sky AI Forum in Bozeman, Montana
- Cryptocurrency Trading: AHRFD Enters German Market with Institutional-Grade Infrastructure
NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP) $NRXP Suitability Petition is required for shift from multidose packaging of ketamine to single-patient dose preservative free ketamine
MIAMI - nvtip -- Developing NRX-101, an FDA-Designated Investigational Breakthrough Therapy for Suicidal Treatment-Resistant Bipolar Depression and Chronic Pain.
Designed to Help Address the Needs of Over 13 Million Americans who Seriously Consider Suicide Each Year (CDC).
H.C. Wainright Analyst Report Cites Paradigm Shift in the Treatment of Depression with Suicidality; Assuming Coverage with Buy and $40 Price Target.
Notification of US Food and Drug Administration Approval of Suitability Petition for NRx's Proposed Strength of Preservative-Free Ketamine.
Dura Medical Acquisition Completed in Network of Interventional Psychiatry Clinics.
FDA Fast Track Designation for NRX 100 for Suicidal Ideation in Patients with Depression, Including Bipolar Depression.
Designation Includes an FDA Determination That NRX-100 has Potential to Address an Unmet Need.
$7.8 Million Debt Financing to Fuel NRXP HOPE Clinic Acquisitions with
Universal Capital, LLC.
Accepted Non-Binding Potential Terms to License and Distribute NRX-100 Drug Providing Over $300 Million in Milestones Plus Tiered Double-Digit Royalties.
NRx Pharmaceuticals, Inc. (N A S D A Q: 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.
More on nvtip.com
H.C. Wainwright has issued a new Analyst Report on NRXP: "A Paradigm Shift in the Treatment of Depression With Suicidality" Assuming Coverage With a Buy and $40 Price Target. The full report may be accessed at this direct link: https://hcwco.bluematrix.com/links2/secure/pdf/acdd3260-630e-48e6-9c2f-03fbc0be37d6
Notification of US Food and Drug Administration Approval of Suitability Petition for NRx's Proposed Strength of Preservative-Free Ketamine
On September 24th NRXP announced that it was notified by the United States Food and Drug Administration (FDA) that a Suitability Petition has been granted for the strength proposed by the Company for its planned single-patient, preservative-free ketamine product (KETAFREE™).
Currently, ketamine is sold in multi-dose vials that contain Benzethonium Chloride, a toxic preservative. The Suitability Petition that has been granted enables immediate re-filing of the NRXP Abbreviated New Drug Application for KETAFREE™. NRXP believes that this proposed product addresses two critical policy objectives as articulated by the current administration: (1) the re-shoring of strategically important drugs, particularly sterile products from foreign manufacturing sources, and (2) the "Make America Healthy Again" (MAHA) objective of removing toxic preservatives and colorants from foods and drugs. These objectives have been articulated on numerous occasions by FDA and HHS leadership.
Dura Medical Acquisition Completed in Network of Interventional Psychiatry Clinics
On September 8th NRXP announced the closing of its acquisition of Dura Medical. Dura, together with the pending Neurospa TMS and Cohen and Associates acquisitions, are planned to provide a comprehensive service offering to patients at more than 8 locations along the West Coast of Florida. Dura is revenue generating and EBITDA positive.
Dura delivers a full range of precision psychiatry services for severe depression and PTSD, including Ketamine Therapy and Transcranial Magnetic Stimulation to Veterans and civilian patients.
Second Quarter 2025 Corporate Update
On August 18th NRXP announced financial results for the quarter ended June 30, 2025, and provided a corporate update. As of June 30, 2025, NRXP had approximately $2.9 million in cash and cash equivalents. NRXP believes that its current cash position will support operations into 2026 and provide sufficient capital to reach expected regulatory inflection points.
More on nvtip.com
The latest NRXP key developments included the following points:
NRXP Drug Development
Grant of expanded Fast Track Designation for NRXP NRX-100 from the FDA for all indications and types of depression and related disorders based on its potential to satisfy an unmet medical need.
Approximately 10-fold expansion of the addressable market to 13 million Americans, compared to the original Fast Track Designation issued in 2017 for bipolar depression alone.
The Designation letter contains a specific finding that NRXP NRX-100 addresses an "unmet medical need." This is a specific qualifying requirement for the Commissioner's National Priority Voucher Program.
NRXP Filing of Commissioner's National Priority Voucher application for intravenous ketamine (NRX-100).
Submission of draft labeling for NRXP NRX-100 in the treatment of suicidal depression based on the Fast Track Designation received.
Filing of an Abbreviated New Drug Application (ANDA) for NRXP NRX-100 (preservative-free intravenous ketamine).
Submission of stability data for NRXP NRX-100 to the manufacturing data on file with FDA sufficient to support three years of room temperature shelf stability for NRX-100.
Filing of a patent application for NRXP NRX-100.
Receipt of a PDUFA filing fee waiver from the FDA for NRXP NRX-100.
NRXP filing of module 3 manufacturing data to support a New Drug Application for NRX-101 in the treatment of patients with suicidal bipolar depression and akathisia despite treatment with already-approved medication.
For more information on $NRXP visit: https://www.nrxpharma.com/ and https://compasslivemedia.com/case-study/nrx-pharmaceuticals/
Media Contact
Company Name: NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP)
Contact Person: Matthew Duffy, Chief Business Officer
Company Website: https://www.nrxpharma.com/
Email: mduffy@nrxpharma.com
Phone: (484) 254-6134
Home Country: United States
DISCLAIMER: https://corporateads.com/disclaimer/
Disclosure listed on the CorporateAds website
Designed to Help Address the Needs of Over 13 Million Americans who Seriously Consider Suicide Each Year (CDC).
H.C. Wainright Analyst Report Cites Paradigm Shift in the Treatment of Depression with Suicidality; Assuming Coverage with Buy and $40 Price Target.
Notification of US Food and Drug Administration Approval of Suitability Petition for NRx's Proposed Strength of Preservative-Free Ketamine.
Dura Medical Acquisition Completed in Network of Interventional Psychiatry Clinics.
FDA Fast Track Designation for NRX 100 for Suicidal Ideation in Patients with Depression, Including Bipolar Depression.
Designation Includes an FDA Determination That NRX-100 has Potential to Address an Unmet Need.
$7.8 Million Debt Financing to Fuel NRXP HOPE Clinic Acquisitions with
Universal Capital, LLC.
Accepted Non-Binding Potential Terms to License and Distribute NRX-100 Drug Providing Over $300 Million in Milestones Plus Tiered Double-Digit Royalties.
NRx Pharmaceuticals, Inc. (N A S D A Q: 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.
More on nvtip.com
- Are TV Commercials A Good Return On Investment?
- New Tagalog-English Phrasebook Makes Learning Filipino Fun and Easy
- Psalmist Sylmac Announces Release of "You Reign" – A Powerful New Worship Song
- New Activity Book Makes Learning Vowel Trigraphs Fun for Young Readers
- Nashville International Chopin Piano Competition partners with Lipscomb University to host 2025 competition
H.C. Wainwright has issued a new Analyst Report on NRXP: "A Paradigm Shift in the Treatment of Depression With Suicidality" Assuming Coverage With a Buy and $40 Price Target. The full report may be accessed at this direct link: https://hcwco.bluematrix.com/links2/secure/pdf/acdd3260-630e-48e6-9c2f-03fbc0be37d6
Notification of US Food and Drug Administration Approval of Suitability Petition for NRx's Proposed Strength of Preservative-Free Ketamine
On September 24th NRXP announced that it was notified by the United States Food and Drug Administration (FDA) that a Suitability Petition has been granted for the strength proposed by the Company for its planned single-patient, preservative-free ketamine product (KETAFREE™).
Currently, ketamine is sold in multi-dose vials that contain Benzethonium Chloride, a toxic preservative. The Suitability Petition that has been granted enables immediate re-filing of the NRXP Abbreviated New Drug Application for KETAFREE™. NRXP believes that this proposed product addresses two critical policy objectives as articulated by the current administration: (1) the re-shoring of strategically important drugs, particularly sterile products from foreign manufacturing sources, and (2) the "Make America Healthy Again" (MAHA) objective of removing toxic preservatives and colorants from foods and drugs. These objectives have been articulated on numerous occasions by FDA and HHS leadership.
Dura Medical Acquisition Completed in Network of Interventional Psychiatry Clinics
On September 8th NRXP announced the closing of its acquisition of Dura Medical. Dura, together with the pending Neurospa TMS and Cohen and Associates acquisitions, are planned to provide a comprehensive service offering to patients at more than 8 locations along the West Coast of Florida. Dura is revenue generating and EBITDA positive.
Dura delivers a full range of precision psychiatry services for severe depression and PTSD, including Ketamine Therapy and Transcranial Magnetic Stimulation to Veterans and civilian patients.
Second Quarter 2025 Corporate Update
On August 18th NRXP announced financial results for the quarter ended June 30, 2025, and provided a corporate update. As of June 30, 2025, NRXP had approximately $2.9 million in cash and cash equivalents. NRXP believes that its current cash position will support operations into 2026 and provide sufficient capital to reach expected regulatory inflection points.
More on nvtip.com
- All Y'alls Foods Expands Global Reach: It's Jerky Y'all Now Available on Amazon Across 10 European Marketplaces
- Health Insurance Notices from Employers
- 16653 Broadwater Ave in Winter Garden's Twinwaters Community Goes Under Contract in Just 22 Days — Far Outpacing the Local Average
- Dr. Frederic Scheer to Speak at Big Sky AI Forum in Bozeman, Montana
- Paradigm Shift: "Users Will Own, Control & Monetize Their Data at all Times Throughout the Netverse App-less Ecosystem" Says Phinge CEO
The latest NRXP key developments included the following points:
NRXP Drug Development
Grant of expanded Fast Track Designation for NRXP NRX-100 from the FDA for all indications and types of depression and related disorders based on its potential to satisfy an unmet medical need.
Approximately 10-fold expansion of the addressable market to 13 million Americans, compared to the original Fast Track Designation issued in 2017 for bipolar depression alone.
The Designation letter contains a specific finding that NRXP NRX-100 addresses an "unmet medical need." This is a specific qualifying requirement for the Commissioner's National Priority Voucher Program.
NRXP Filing of Commissioner's National Priority Voucher application for intravenous ketamine (NRX-100).
Submission of draft labeling for NRXP NRX-100 in the treatment of suicidal depression based on the Fast Track Designation received.
Filing of an Abbreviated New Drug Application (ANDA) for NRXP NRX-100 (preservative-free intravenous ketamine).
Submission of stability data for NRXP NRX-100 to the manufacturing data on file with FDA sufficient to support three years of room temperature shelf stability for NRX-100.
Filing of a patent application for NRXP NRX-100.
Receipt of a PDUFA filing fee waiver from the FDA for NRXP NRX-100.
NRXP filing of module 3 manufacturing data to support a New Drug Application for NRX-101 in the treatment of patients with suicidal bipolar depression and akathisia despite treatment with already-approved medication.
For more information on $NRXP visit: https://www.nrxpharma.com/ and https://compasslivemedia.com/case-study/nrx-pharmaceuticals/
Media Contact
Company Name: NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP)
Contact Person: Matthew Duffy, Chief Business Officer
Company Website: https://www.nrxpharma.com/
Email: mduffy@nrxpharma.com
Phone: (484) 254-6134
Home Country: United States
DISCLAIMER: https://corporateads.com/disclaimer/
Disclosure listed on the CorporateAds website
Source: Corporate Ads
Filed Under: Media
0 Comments
Latest on nvtip.com
- $20 Target in Noble Capital Markets Report Supported by Live Stream of 1ST Global Super League Kerala Event from AI Powered Sports Leader: $SEGG
- Vesica Health Granted PLA Billing Code for AssureMDx
- Laughter in Tough Times: Delirious Comedy Club Sets the Gold Standard for Comedy in Las Vegas
- Newest Mako Smartrobotics™ System Used for First Time in the State Of Illinois for Total Joint Replacement Surgery
- $20 Million Annualized Revenue Projected from 20+ Acquisitions and Scaling of Top Quality Dental Labs Across Florida: Standard Dental Labs $TUTH
- Grok Wrote a Direct Message to Elon Musk Discussing Netverse & Phinge CEOs Challenge to Live Debate & Added "it'd be epic to see you two hash it out"
- Assent Recognized as a Leader in First-Ever Product Compliance Green Quadrant
- Tina Glasneck Launches New Romantasy, A Dragon's Queen, Blending Dragons, Fae Courts, and Forbidden Love
- Announcing the "Utsunomiya Gyoza Festival 2025" to be held November 1 and 2 in Utsunomiya City, Tochigi Pref, Japan
- Phinge's Netverse Verified AI Offers the Solution to Hollywood's Gravest Fears Over Likeness & IP Misuse: Actors Writers Directors to Control Their IP
- TradeTek 3.0 Mac and Windows Construction Estimating Software
- Lineus Medical Obtains CE Mark for Flagship Product SafeBreak Vascular
- Sine Nomine Associates: OpenAFS Google Summer of Code projects have been completed
- HuskyTail Digital Marketing Rings in Fall with Free SEO Audits for Local Businesses
- David White DDS Advances Implant Dentistry with New Technology Acquisition
- Synthera™ Unveils Chameleon™: Creating a new Paradigm in ML training for Computer Vision
- Final Countdown: The OpenSSL Conference 2025 Begins in One Week
- New Frontier Aerospace Appoints Industry Veteran Rich Pournelle as Director of Business Development
- AI's Urgent Energy Requirements Won't Be Solved By Trillions Of Dollars. Phinge's Patented App-Less Netverse Platform & Hardware Will Reduce This Need
- SportsGuruConsulting.com Launches: The Future of Beating Vegas is Here