NRX Pharmaceuticals' NRX-100 Receives FDA Fast Track Designation Supported by 70,000 Patient Real-World Evidence
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 14 2026
0mins
Source: Globenewswire
- 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.
Discover Tomorrow's Bullish Stocks Today
Receive free daily stock recommendations and professional analysis to optimize your portfolio's potential.
Sign up now to unlock expert insights and stay one step ahead of the market trends.
Analyst Views on NRXP
Wall Street analysts forecast NRXP stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for NRXP is 37.67 USD with a low forecast of 25.00 USD and a high forecast of 48.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 2.110
Low
25.00
Averages
37.67
High
48.00
Current: 2.110
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.
Continue Reading
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.
Continue Reading