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NEW YORK - The U.S. Food and Drug Administration has granted Fast Track Designation for NRx Pharmaceuticals Inc.’s (NASDAQ:NRXP) NRX-100 treatment for suicidal ideation in patients with depression, including bipolar depression, the company announced Monday. The micro-cap pharmaceutical company, currently valued at $49.15 million, has seen its stock climb nearly 25% over the past year according to InvestingPro data.
The designation expands the potential patient population tenfold compared to the FDA’s 2017 Fast Track designation that covered only bipolar depression. The broader designation now includes approximately 13 million U.S. adults who consider suicide annually. Analysts tracking the company on InvestingPro have set price targets ranging from $18 to $46, suggesting significant potential upside from current levels.
NRX-100, a preservative-free intravenous ketamine formulation, has demonstrated rapid reductions in suicidal ideation in multiple clinical trials, including studies from Columbia University and the Government of France.
"This recognition is a major step toward addressing the national crisis of suicide affecting civilians, soldiers, veterans, and first responders," said Dr. Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals, in a press release statement.
The Fast Track status qualifies NRX-100 for eligibility under the Commissioner’s National Priority Voucher Program and accelerated approval pathways. Under the program, NRx plans to seek Accelerated Approval and Priority Review, and will post an expanded access policy within two weeks.
The company highlighted that its formulation eliminates benzethonium chloride, a preservative found in some ketamine products, and has initiated U.S. high-volume manufacturing. The treatment has a three-year room-temperature shelf life.
NRx Pharmaceuticals has filed both an Abbreviated New Drug Application and initiated a New Drug Application for NRX-100, along with an application for the Commissioner’s National Priority Voucher Program. With earnings scheduled for August 14, InvestingPro analysts project the company will achieve profitability this year, marking a potential turning point in its financial trajectory. InvestingPro subscribers can access 8 additional key insights and a comprehensive Pro Research Report about NRXP’s financial health and growth prospects.
In other recent news, NRx Pharmaceuticals reported a net loss of $5.5 million for the first quarter of 2025, which marks an improvement from the $6.5 million loss recorded in the same period last year. The company has expressed optimism about achieving profitability by the end of 2025, aiming to do so through potential FDA approvals and strategic expansion efforts. Additionally, NRx Pharmaceuticals announced that the U.S. Food and Drug Administration granted Fast Track designation to its NRX-100 treatment for suicidal ideation in patients with depression, significantly expanding its addressable market.
In further developments, HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, received final clearance from Florida’s Agency for Health Care Administration to proceed with the acquisition of Dura Medical LLC, a provider of interventional psychiatry services. The subsidiary also signed a binding letter of intent to acquire a 49% interest in Cohen and Associates, a psychiatry clinic in Florida, which is expected to positively impact revenue and EBITDA. Moreover, NRx Pharmaceuticals has submitted an Abbreviated New Drug Application to the FDA for a preservative-free intravenous ketamine formulation, addressing the ongoing U.S. drug shortage. This move aligns with efforts to eliminate harmful preservatives from pharmaceuticals and meets the rising demand in the ketamine market.
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