NRx deploys FDA-cleared robotic TMS system in Florida

NRx Pharmaceuticals (NRXP) received an earlier FDA goal date of Nov. 10 for its preservative-free ketamine application after the FDA reclassified a filing amendment from major to minor, reducing review resources. The company aims to address a drug shortage with this product, according to its CEO.

NRX Pharmaceuticals (NRXP) announced FDA reclassified its ANDA from Major to Minor Amendment, resetting GDUFA goal date to November 10. The company's P/S ratio is 30.5, below historical median of 42.3. GF Score is 31, indicating financial challenges but strong momentum. One premium guru holds and recently added to their position. NRXP focuses on developing therapeutics for CNS disorders and pulmonary diseases, with no meaningful product revenue.

NRx Pharmaceuticals (NRXP) reported that the FDA reclassified its ANDA amendment from 'Major' to 'Minor,' advancing the GDUFA goal date to November 10. The company stated this reclassification will not require significant FDA resources. NRx's CEO expressed gratitude for the expedited approval process.

NRx Pharmaceuticals' subsidiary HOPE Therapeutics is deploying Zeta Surgical's FDA-cleared robotic TMS system, with training underway. The AI-driven system offers submillimeter precision for treating depression. This supports NRx's SPARC-TMS trial with NRX-101, involving military and civilian sites. NRx is presenting at the 2026 Cantor Global Healthcare Conference.

NRx Pharmaceuticals (NRXP) targets 2026 FDA approval for KETAFREE, its preservative-free ketamine product, with one remaining deficiency in review. The company ordered 5M units for launch and estimates a $750M market. NRx also advances a 400-patient DARPA-backed trial for NRX-101 and aims for 2027 approval of NRX-100. Q2 2026 net loss improved to $18M, with $26.7M cash on hand.

NRx Pharmaceuticals (NRXP) reported Q2 2026 results, highlighting FDA progress for preservative-free ketamine, $22.3M raised, and DARPA funding potential. The company submitted the final FDA attestation, is manufacturing 5M doses, and expects approval in 2026. Cash reserves support operations for at least a year.