NRx Pharmaceuticals Completes FDA Meeting, Plans to File for NRX-100 New Drug Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Should l Buy NRXP?
NRx Pharmaceuticals announced that it has completed an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration. The meeting was attended by leaders of the FDA Division of Psychiatry Products, the FDA Office of Neuroscience, and the FDA Center for Drug Evaluation and Research. Based on oral guidance received at the meeting, NRx believes it has a path to filing an application for New Drug Approval of NRX-100 based on Substantial Evidence of Effectiveness derived from existing data from adequate and well controlled trials together with confirmatory evidence from more than 65,000 patients identified in the Real World Evidence dataset. NRx will additionally seek a broader indication to serve patients with treatment resistant depression in the context of suicidality, rather than only the subset of patients with suicidality.
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Analyst Views on NRXP
Wall Street analysts forecast NRXP stock price to rise
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 1.775
Low
25.00
Averages
37.67
High
48.00
Current: 1.775
Low
25.00
Averages
37.67
High
48.00
About NRXP
NRx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing therapeutics based on its N-methyl-D-aspartate (NMDA) platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. It is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal Ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal depression. Its subsidiary, HOPE Therapeutics, Inc., is a healthcare delivery company that is building a network of interventional psychiatry clinics.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
NRx and FDA Meeting Advances New Drug Application for NRX-100
- FDA Guidance Meeting: NRx held an in-person meeting with leaders from the FDA Division of Psychiatry Products and the Center for Drug Evaluation and Research, receiving oral guidance that clarifies a path for filing a New Drug Application for NRX-100, potentially accelerating the drug's market entry.
- Clinical Data Support: NRx plans to leverage existing clinical trial data and Real World Evidence from over 65,000 patients to seek a broader indication for NRX-100, aiming to assist more patients with treatment-resistant depression, particularly those with suicidality, demonstrating the company's keen insight into patient needs.
- No Additional Data Required: Preliminary feedback from the FDA indicates that no additional nonclinical data will be necessary for NRx's application, nor will bridging studies be required to support the preservative-free formulation, significantly reducing the complexity and timeline of the application process, thereby enhancing NRx's market competitiveness.
- Strategic Collaboration Outlook: NRx's collaboration with the FDA will focus on finalizing the statistical analysis protocol, which is expected to further strengthen NRx's influence in the mental health space and lay the groundwork for future drug development, especially in meeting the needs of veterans and first responders.
See More
NRx Pharmaceuticals Sets Date for 2025 Annual Meeting and Proposal Deadline
- Annual Meeting Date: NRx Pharmaceuticals has announced that the 2025 Annual Meeting will be held on March 23, 2026, in a virtual format, aimed at enhancing shareholder engagement and adapting to current digital trends.
- Proposal Deadline: The deadline for shareholder proposals is set for January 26, 2026, ensuring shareholders have ample time to prepare submissions, reflecting the company's commitment to shareholder input.
- Proposal Rule Update: The change in proposal rules due to the 2025 Annual Meeting being more than a year after the 2024 meeting indicates the company's flexibility in governance structures.
- Future Development Focus: NRx Pharmaceuticals is developing therapeutics for central nervous system disorders, particularly suicidal depression and chronic pain, demonstrating the company's dedication to innovation and market demand.
See More
NRx Pharmaceuticals Licenses RWE from 70,000 Patients to Support NRX-100 FDA Approval
- Real World Evidence License: NRx Pharmaceuticals has licensed Real World Evidence from over 70,000 U.S. patients, a significant step toward FDA approval for its investigational drug NRX-100 (preservative-free ketamine), highlighting the company's strategic focus in mental health.
- Collaboration Platform: The data is sourced from Osmind, a neuropsychiatry technology platform widely used in U.S. clinics, providing detailed regulatory-grade patient records that enhance NRx's data support for FDA submissions.
- Accelerated Approval Support: Through collaboration with Osmind, NRx can submit a comprehensive dataset to the FDA to support NRX-100's Accelerated Approval under its Fast Track Designation, further boosting its competitive position in the market.
- Stock Price Reaction: Following this announcement, NRx Pharmaceuticals' stock traded over 21% higher in Wednesday's premarket, reflecting positive market sentiment towards its research progress and potentially providing more opportunities for future financing and expansion.
See More
NRX Pharmaceuticals' NRX-100 Receives FDA Fast Track Designation Supported by 70,000 Patient Real-World Evidence
- FDA Fast Track Designation: NRX-100 (preservative-free ketamine) has received Fast Track Designation from the FDA for treating suicidal ideation in patients with depression and bipolar depression, marking a significant advancement in the mental health sector.
- Real-World Evidence Support: NRx collaborates with Osmind to leverage real-world data from over 70,000 patients, demonstrating ketamine's efficacy in rapidly alleviating depression and suicidal ideation, which is expected to provide strong support for Accelerated Approval.
- Positive Clinical Response: Preliminary analysis indicates that results from a subset of 20,000 patients align with randomized trial data, suggesting that NRX-100 offers a superior clinical response compared to currently approved treatments, potentially providing new options for patients.
- Expanding Drug Accessibility: NRx is applying for FDA Accelerated Approval to broaden the use of NRX-100 under appropriate medical supervision, aiming to help more patients relying on other health insurance access this potentially life-saving medication.
See More
BTIG Raises Hudson Pacific Price Target to $26
- Target Price Increase: BTIG raised Hudson Pacific Properties' price target from $4.75 to $26, with analyst Thomas Catherwood maintaining a Buy rating, indicating strong confidence in the company's future growth prospects.
- Market Performance: Hudson Pacific shares closed at $10.83 on Wednesday, and despite the significant target price increase, the current stock price remains below the target, suggesting a market undervaluation of its potential.
- NRx Pharmaceuticals Target Adjustment: Ascendiant Capital increased the price target for NRx Pharmaceuticals from $47 to $48, with analyst Edward Woo maintaining a Buy rating, reflecting optimism about the company's product outlook.
- Ulta Beauty Target Upgrade: Argus Research raised Ulta Beauty's price target from $650 to $700, with analyst Deborah Ciervo maintaining a Buy rating, indicating positive expectations for its market performance.
See More
NRx Pharmaceuticals Repays $5.4 Million Debt, Positions for Accelerated Growth in 2026
- Debt Repayment: NRx Pharmaceuticals has repaid the remaining $5.4 million in debt through equity conversion of common stock, ensuring a debt-free balance sheet by the end of 2025, which sets the stage for future drug approvals and clinic expansions.
- Capital Structure Optimization: This repayment positions the company for accelerated growth in 2026, with anticipated drug approvals aimed at treating suicidal depression and PTSD, thereby enhancing its competitive edge in the market.
- Financing Background: Anson Funds originally lent $16.2 million to NRx to fund prior loan repayments and corporate operating expenses, and this equity conversion was executed without additional warrants or repricing mechanisms, showcasing the company's flexibility in its financing structure.
- Future Outlook: The CEO of NRx expressed gratitude to Anson Funds for their support during challenging times in the biotech equity market, enabling the advancement of pharmaceutical and clinical programs, with significant clinical expansions and drug approvals expected in 2026.
See More
NRx and FDA Meeting Advances New Drug Application for NRX-100
- FDA Guidance Meeting: NRx held an in-person meeting with leaders from the FDA Division of Psychiatry Products and the Center for Drug Evaluation and Research, receiving oral guidance that clarifies a path for filing a New Drug Application for NRX-100, potentially accelerating the drug's market entry.
- Clinical Data Support: NRx plans to leverage existing clinical trial data and Real World Evidence from over 65,000 patients to seek a broader indication for NRX-100, aiming to assist more patients with treatment-resistant depression, particularly those with suicidality, demonstrating the company's keen insight into patient needs.
- No Additional Data Required: Preliminary feedback from the FDA indicates that no additional nonclinical data will be necessary for NRx's application, nor will bridging studies be required to support the preservative-free formulation, significantly reducing the complexity and timeline of the application process, thereby enhancing NRx's market competitiveness.
- Strategic Collaboration Outlook: NRx's collaboration with the FDA will focus on finalizing the statistical analysis protocol, which is expected to further strengthen NRx's influence in the mental health space and lay the groundwork for future drug development, especially in meeting the needs of veterans and first responders.
See More
NRx Pharmaceuticals Sets Date for 2025 Annual Meeting and Proposal Deadline
- Annual Meeting Date: NRx Pharmaceuticals has announced that the 2025 Annual Meeting will be held on March 23, 2026, in a virtual format, aimed at enhancing shareholder engagement and adapting to current digital trends.
- Proposal Deadline: The deadline for shareholder proposals is set for January 26, 2026, ensuring shareholders have ample time to prepare submissions, reflecting the company's commitment to shareholder input.
- Proposal Rule Update: The change in proposal rules due to the 2025 Annual Meeting being more than a year after the 2024 meeting indicates the company's flexibility in governance structures.
- Future Development Focus: NRx Pharmaceuticals is developing therapeutics for central nervous system disorders, particularly suicidal depression and chronic pain, demonstrating the company's dedication to innovation and market demand.
See More
NRx Pharmaceuticals Licenses RWE from 70,000 Patients to Support NRX-100 FDA Approval
- Real World Evidence License: NRx Pharmaceuticals has licensed Real World Evidence from over 70,000 U.S. patients, a significant step toward FDA approval for its investigational drug NRX-100 (preservative-free ketamine), highlighting the company's strategic focus in mental health.
- Collaboration Platform: The data is sourced from Osmind, a neuropsychiatry technology platform widely used in U.S. clinics, providing detailed regulatory-grade patient records that enhance NRx's data support for FDA submissions.
- Accelerated Approval Support: Through collaboration with Osmind, NRx can submit a comprehensive dataset to the FDA to support NRX-100's Accelerated Approval under its Fast Track Designation, further boosting its competitive position in the market.
- Stock Price Reaction: Following this announcement, NRx Pharmaceuticals' stock traded over 21% higher in Wednesday's premarket, reflecting positive market sentiment towards its research progress and potentially providing more opportunities for future financing and expansion.
See More
NRX Pharmaceuticals' NRX-100 Receives FDA Fast Track Designation Supported by 70,000 Patient Real-World Evidence
- FDA Fast Track Designation: NRX-100 (preservative-free ketamine) has received Fast Track Designation from the FDA for treating suicidal ideation in patients with depression and bipolar depression, marking a significant advancement in the mental health sector.
- Real-World Evidence Support: NRx collaborates with Osmind to leverage real-world data from over 70,000 patients, demonstrating ketamine's efficacy in rapidly alleviating depression and suicidal ideation, which is expected to provide strong support for Accelerated Approval.
- Positive Clinical Response: Preliminary analysis indicates that results from a subset of 20,000 patients align with randomized trial data, suggesting that NRX-100 offers a superior clinical response compared to currently approved treatments, potentially providing new options for patients.
- Expanding Drug Accessibility: NRx is applying for FDA Accelerated Approval to broaden the use of NRX-100 under appropriate medical supervision, aiming to help more patients relying on other health insurance access this potentially life-saving medication.
See More
BTIG Raises Hudson Pacific Price Target to $26
- Target Price Increase: BTIG raised Hudson Pacific Properties' price target from $4.75 to $26, with analyst Thomas Catherwood maintaining a Buy rating, indicating strong confidence in the company's future growth prospects.
- Market Performance: Hudson Pacific shares closed at $10.83 on Wednesday, and despite the significant target price increase, the current stock price remains below the target, suggesting a market undervaluation of its potential.
- NRx Pharmaceuticals Target Adjustment: Ascendiant Capital increased the price target for NRx Pharmaceuticals from $47 to $48, with analyst Edward Woo maintaining a Buy rating, reflecting optimism about the company's product outlook.
- Ulta Beauty Target Upgrade: Argus Research raised Ulta Beauty's price target from $650 to $700, with analyst Deborah Ciervo maintaining a Buy rating, indicating positive expectations for its market performance.
See More
NRx Pharmaceuticals Repays $5.4 Million Debt, Positions for Accelerated Growth in 2026
- Debt Repayment: NRx Pharmaceuticals has repaid the remaining $5.4 million in debt through equity conversion of common stock, ensuring a debt-free balance sheet by the end of 2025, which sets the stage for future drug approvals and clinic expansions.
- Capital Structure Optimization: This repayment positions the company for accelerated growth in 2026, with anticipated drug approvals aimed at treating suicidal depression and PTSD, thereby enhancing its competitive edge in the market.
- Financing Background: Anson Funds originally lent $16.2 million to NRx to fund prior loan repayments and corporate operating expenses, and this equity conversion was executed without additional warrants or repricing mechanisms, showcasing the company's flexibility in its financing structure.
- Future Outlook: The CEO of NRx expressed gratitude to Anson Funds for their support during challenging times in the biotech equity market, enabling the advancement of pharmaceutical and clinical programs, with significant clinical expansions and drug approvals expected in 2026.
See More
