Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
First-cycle review completed · the FDA goal date for this ANDA was July 29, 2026; on July 30, 2026 the FDA completed its first-cycle review, identifying no major deficiencies relating to the drug components and one major deficiency relating to the container closure system (the vial's Luer-lock tip); NRx says it has submitted the requested manufacturer's attestation and targets approval in 2026. No approval has been published as of October 11, 2026. KETAFREE is an abbreviated new drug application, so its target is a GDUFA goal date rather than a PDUFA date. Per NRx's Q2 2026 Form 10-Q and its August 17, 2026 release, on July 30, 2026 the FDA notified the company that its first-round review identified no major deficiencies relating to the drug components of the product but a major deficiency relating to the container closure system; the company said it has provided the manufacturer's attestation on the vial's Luer-lock tip. A first-cycle deficiency letter is not an approval. NRx Pharmaceuticals Q2 2026 Form 10-Q (SEC EDGAR); NRx release on the first-cycle review.
FDA decision (PDUFA) target 2026-07-29 · NRX Pharmaceuticals Inc. · Preservative-free intravenous ketamine formulation
KETAFREE was under FDA review with a goal date of July 29, 2026; on July 30, 2026 the FDA completed its first-cycle review, identifying no major deficiencies relating to the drug components and one major deficiency relating to the container closure system (the vial's Luer-lock tip); NRx says it has submitted the requested manufacturer's attestation and targets approval in 2026. It is intended to treat pain, using a preservative-free IV ketamine formulation.
The FDA goal date (ANDA) 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 whose FDA goal date was July 29, 2026; on July 30, 2026 the FDA completed its first-cycle review, identifying no major deficiencies relating to the drug components and one major deficiency relating to the container closure system (the vial's Luer-lock tip); NRx says it has submitted the requested manufacturer's attestation and targets approval in 2026. It is intended 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
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.