NRx Receives FDA Acknowledgment for KETAFREE™ ANDA, Targeting July 2026 Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 02 2025
0mins
Should l Buy NRXP?
Source: Newsfilter
- Application Progress: NRx's ANDA for KETAFREE™ has been acknowledged as 'substantially complete' by the FDA, with a target review completion date of July 29, 2026, which could significantly enhance the company's competitive position in the $750 million global ketamine market upon approval.
- Product Innovation: KETAFREE™ is the first preservative-free ketamine formulation, addressing growing safety concerns in the market, and is expected to attract more clinical users and patients seeking safer alternatives.
- Production Capacity: NRx has manufactured initial registration lots and is prepared to scale production to 1 million vials per month, ensuring rapid market supply post-approval and enhancing the company's revenue potential.
- Strategic Alignment: The development of KETAFREE™ aligns with the FDA's initiatives to remove toxic substances, demonstrating NRx's commitment to drug safety, which may provide the company with a long-term market advantage.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy NRXP?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
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: 1.730
Low
25.00
Averages
37.67
High
48.00
Current: 1.730
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 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 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, marking a significant milestone as the company anticipates ending 2025 with a debt-free balance sheet, thereby laying the groundwork for future drug approvals and clinic expansions.
- Capital Structure Optimization: This repayment positions NRx for accelerated growth in 2026, which is expected to enhance its drug development pipeline targeting suicidal depression and PTSD, thereby improving its competitive stance in the market.
- Financing Background: Anson Funds originally lent $16.2 million to NRx to support the repayment of prior loans and corporate operating expenses, and this equity conversion was executed without any associated warrants or repricing mechanisms, demonstrating 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 for biotechnology equities, enabling the advancement of pharmaceutical and clinical programs, with potential drug approvals and expansions anticipated in 2026.
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 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, marking a significant milestone as the company anticipates ending 2025 with a debt-free balance sheet, thereby laying the groundwork for future drug approvals and clinic expansions.
- Capital Structure Optimization: This repayment positions NRx for accelerated growth in 2026, which is expected to enhance its drug development pipeline targeting suicidal depression and PTSD, thereby improving its competitive stance in the market.
- Financing Background: Anson Funds originally lent $16.2 million to NRx to support the repayment of prior loans and corporate operating expenses, and this equity conversion was executed without any associated warrants or repricing mechanisms, demonstrating 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 for biotechnology equities, enabling the advancement of pharmaceutical and clinical programs, with potential drug approvals and expansions anticipated in 2026.
See More
