NRx said the FDA’s fast-track status makes NRX-100 eligible for the Commissioner’s National Priority Voucher program and the FDA’s Accelerated Approval pathway, and the company has already applied for a CNPV.
Retail buzz around NRx Pharmaceuticals picked up Monday after the company said that the U.S. Food and Drug Administration (FDA) granted fast-track designation to its NRX-100 therapy for treating suicidal thoughts in patients with depression, including bipolar depression.
The new designation means NRX-100 could be used to treat about 13 million Americans who consider suicide each year, which is 10x more than under its 2017 designation, which covered only bipolar depression when combined with NRX-101.
However, NRx Pharmaceuticals’ stock closed down 7.9% at $0.2 on Monday, then inched up 0.2% in after-hours trading.
The FDA determined NRX-100 has the potential to address an unmet medical need, making the drug eligible for the Commissioner’s National Priority Voucher (CNPV) program and the agency’s Accelerated Approval pathway.
NRx said it has applied for a CNPV, which could shorten the review cycle.
The company cited multiple controlled trials submitted to the FDA that showed clinically meaningful reductions in suicidal ideation with intravenous ketamine. In a Columbia University study licensed by NRx, 55% of patients met the response criteria compared with 30% for an active comparator.
In a French government-sponsored study also licensed by NRx, 63% of participants achieved remission within three days, compared to 31% for the placebo group.
CEO Jonathan Javitt said the designation was a “significant step forward” in addressing suicide risk among soldiers, veterans, first responders, and civilians. NRx plans to post an expanded access policy for NRX-100 within two weeks and will meet with the FDA to finalize the data package for its Accelerated Approval and CNPV application.
The company noted that NRX-100 is the first preservative-free ketamine presentation filed with the FDA. Current ketamine products often contain benzethonium chloride, a preservative not recognized as safe by the FDA.
NRx has petitioned the FDA to ban the compound from all intravenous ketamine products and has started producing sterile, preservative-free ketamine in the U.S.
Roughly 13 million U.S. adults seriously think about suicide each year, with 1.5 million attempts and one life lost every 11 minutes, the company said in a statement, citing the CDC.
NRx pointed out that while the Department of Veterans Affairs and the Department of Defense cover intravenous ketamine, most insurers won’t pay for it as it’s only officially approved as an anesthetic.
The fast-track designation provides drugmakers with closer contact with the FDA, the opportunity to qualify for Priority Review and Accelerated Approval if certain requirements are met, and the option to submit parts of an application for review as they are completed.
On Stocktwits, retail sentiment for NRx Pharmaceuticals was ‘extremely bullish’ late Monday amid ‘extremely high’ message volume.
NRx Pharmaceuticals’ stock has risen 5.5% so far in 2025.
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