NRx Pharmaceuticals (NRXP) - Great news again! Today's PR is essentially final confirmation needed for an FDA approval letter on "OR PRIOR TO" the FDA's Nov 10 GDUFA decision date for the KETAFREE ANDA.
NRx Pharmaceuticals is on track for FDA approval of KETAFREE (preservative-free ketamine ANDA) by Nov 10, 2026 GDUFA date with manufacturing validation complete and commercial supply ready. Approval will address a drug shortage, enabling rapid market entry, formulary placement, and potential short squeeze (24% shares shorted), with near-term price target of $10 and upside to $45-50 based on pipeline catalysts.