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WILMINGTON, Del. - NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a clinical-stage pharmaceutical company with a market capitalization of $49.15 million, announced Monday that the U.S. Food and Drug Administration has granted Fast Track designation to its NRX-100 treatment for suicidal ideation in patients with depression, including bipolar depression.
The designation expands the addressable population for NRX-100 to potentially include the estimated 13 million Americans who consider suicide each year, according to the company. This represents a tenfold increase from the previous designation granted in 2017, which was limited to bipolar depression. According to InvestingPro data, analysts expect the company to achieve profitability this year, with earnings forecasts showing positive territory for 2025.
In its assessment, the FDA determined that NRX-100 has the potential to address an unmet medical need based on preliminary data submitted by the company. This determination aligns with eligibility requirements for the Commissioner’s National Priority Voucher Program, which could potentially shorten the review cycle for the drug.
NRX-100 is a preservative-free intravenous ketamine formulation. According to data cited by the company, clinical trials have shown statistically significant reductions in suicidal ideation among patients using the treatment. In one study, 63% of patients achieved full remission from suicidal ideation within three days compared to 31% of those receiving placebo.
"We thank FDA for its thoughtful review of our Fast Track designation request," said Dr. Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals, in a statement based on the press release.
Under the Fast Track program, NRx will post an expanded access policy for NRX-100 within two weeks and seek a meeting with FDA leadership to finalize data for submission under the Accelerated Approval application.
The company has previously filed manufacturing information for NRX-100 with the FDA and reports having stability and sterility data sufficient for an anticipated three-year room temperature shelf life for the preservative-free ketamine formulation.
According to CDC data referenced in the announcement, approximately 13 million adults seriously consider suicide each year in the United States, with 1.5 million attempting suicide. Trading at $2.52, NRXP shares have shown strong momentum with a 14.55% gain year-to-date, though InvestingPro analysis indicates the stock remains slightly undervalued. Investors anticipating the company’s upcoming earnings report, scheduled for August 14, can access comprehensive financial analysis and additional ProTips through the Pro Research Report, available exclusively to subscribers.
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 in the same period last year. The company is targeting profitability by the end of 2025, relying on potential FDA approvals and strategic expansion plans. HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, has received final clearance from Florida’s Agency for Health Care Administration to proceed with its acquisition of Dura Medical LLC. Additionally, HOPE Therapeutics announced a binding letter of intent to acquire a 49% interest in Cohen and Associates, an interventional psychiatry clinic in western Florida, which is expected to positively impact revenue and EBITDA.
NRx Pharmaceuticals has also filed an Abbreviated New Drug Application with the FDA for NRX-100, a preservative-free intravenous ketamine formulation. This move is in response to the ongoing U.S. drug shortage of ketamine and aligns with efforts to eliminate harmful preservatives. The ketamine market is currently valued at $750 million, with projections indicating significant growth by 2034. These developments reflect NRx Pharmaceuticals’ efforts to expand its market presence and improve its financial outlook.
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