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Home › PDUFA Calendar › NRXP

NRXP PDUFA Date: KETAFREE

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-07-29 · NRX Pharmaceuticals Inc. · Preservative-free intravenous ketamine formulation
More CNS & Neurology FDA decisions →All July 2026 PDUFA dates →

The story

KETAFREE is under FDA review to treat pain, using a preservative-free IV ketamine formulation.
Full PDUFA calendar ->Every upcoming FDA decision date, by monthLNTH-florquinitau . 2026-08-13Same area: Neurology . Florquinitau (MK-6240)CAPR . 2026-08-22Same area: Neurology . Deramiocel (CAP-1002)VERA . 2026-07-07Same month decision . Atacicept
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

NRXP run-up into the PDUFA (last ~120 days)

$4.62$1.7
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-07-29
Drug / candidateKETAFREE
IndicationPreservative-free intravenous ketamine formulation
CompanyNRX Pharmaceuticals Inc.
Market-cap tierMicro
Cohort decision-day move (history)±7% median
ClinicalTrials.govNot listed

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FAQ

When is the NRXP PDUFA date?
The FDA PDUFA target date for NRXP (NRX Pharmaceuticals Inc.) is 2026-07-29 for KETAFREE. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is NRXP's drug KETAFREE?
KETAFREE is NRX Pharmaceuticals Inc.'s candidate under FDA review for Preservative-free intravenous ketamine formulation.
What typically happens to a micro-cap stock into a PDUFA date?
Historically, micro-cap names had a median decision-day move around ±5% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · micro-cap cohortn=302 · median -0.9% · 43% up
under -30%: 26 of 302 (9%)<-30-30 to -15%: 15 of 302 (5%)-15 to -7%: 24 of 302 (8%)-7 to -3%: 36 of 302 (12%)-3 to +3%: 118 of 302 (39%)±3+3 to +7%: 38 of 302 (13%)+7 to +15%: 19 of 302 (6%)+15 to +30%: 11 of 302 (4%)over +30%: 13 of 302 (4%)>+30
Distribution of next-day % moves after the FDA decision for micro-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.