Trending...
- Cancer Survivor Roslyn Franken Marks 30-Year Milestone with Empowering Gift for Women Survivors
- Naperville Seeks Community Input to Update Bicycle and Pedestrian Plan
- Grammy award-winning Cuban-Canadian artist Alex Cuba releases his 11th studio album, "Indole"
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 - illiNews -- 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 illi News
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 illi News
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 illi News
- America Anesthesia Partners Unveils New User-Friendly Website
- Hiclean Tools Releases HCX2100 Electric Pressure Washer
- Bùng Nổ Ra Mắt, AALIVE Tung Gói Thưởng 68% và Dàn Game Thuần Việt Hấp Dẫn
- ARCH Dental + Aesthetics Offers Free Consultations for New Patients
- Maisano Brothers Inc. Expands National Paving Division Into Tampa, Florida
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 illi News
- Multi-Signature Cold Storage: Keyanb Introduces Institutional-Grade Asset Protection for Chilean Crypto Traders
- NKSCX Introduces Zero-Knowledge Proof of Solvency for U.S. Traders Amid $6.5 Billion Fraud Crisis
- New Oasis International Foundation Announces Strategic Partnership Network Across 15 Countries to Advance Community-Led Economic Development
- Some Music for Donald's Bad Day
- New You Smile Dental Implant Center Expands Office
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: Financial
0 Comments
Latest on illi News
- Podcast for Midlife Women Entrepreneurs Celebrates 100th Episode with Rhea Lana's Founder and CEO
- What If Help Could Come Before the Fall?
- Digi 995: Spookyverse — Unlocking the Multiverse of the Digiverse
- ENERICom Channel Releases EPISODE 5 "Pure Michigan in Autumn"
- OddsTrader Examines the NHL Presidents Trophy Curse: Why Regular-Season Success Rarely Leads to Playoff Glory
- Bookmakers Review Launches Betting Insights on NBC's "The Voice: Battle of Champions"
- Coming Up this Weekend on CNBC Mike Milligan Joins Tom Hegna on "Financial Freedom with Tom Hegna"
- Chicago: Mayor Brandon Johnson, BACP Announces Request For Proposals For Driver Resource Center
- Mayor Brandon Johnson, Department of Streets and Sanitation, And Chicago Public Library Expand Food Scrap Drop-Off Program To 13 New Library Locations
- Mayor Brandon Johnson Announces the Return Of "Chicago Fall Fest" From Oct. 17-Nov. 2, Featuring Hundreds Of City-Supported Events For Youth and All Residents
- Predatory Refinancing: How Homeowners Fall Into the Equity Trap Without Realizing It
- UK Website Launches "Toy Time Machine" — Find Your Childhood Christmas Toy in One Click
- Stay Safe in Style: The DR. ORGANIZER Personal Purse Alarm Delivers Powerful Protection in a Compact Design
- The Tiny Kitchen Tool That Solves a Big Cooking Headache
- Why Every Dog Deserves a Milo's Choice Towel
- The Secret to Shoes That Actually Fit: Meet the Little Toe Guard
- $73.6M Pipeline, $10M Crypto Play & Legal Firepower: Why Investors Are Watching Cycurion (N A S D A Q: CYCU) Like a Hawk
- Grammy award-winning Cuban-Canadian artist Alex Cuba releases his 11th studio album, "Indole"
- Thread Advisory Group Launches to Help Retailers Turn Strategy Into Lasting Results
- QView Medical and Eve Wellness Announce Partnership to Advance Direct-to-Consumer Breast Cancer Screening With FDA-Approved AI