Ketamine, CBD & psychedelics gain traction
Regulatory and commercial momentum is building for ketamine‑assisted and related neuroplastic therapies — NRx says its ketamine review is advancing and the company can fund operations through 2026, while federal guidance expanded Medicare details for hemp CBD/THC and Utah passed a new psychedelics bill. ( - - )
NRx reported $7.8 million in cash at December 31, 2025 and said its loss from operations narrowed to about $16.2 million for the year, while the company projects adequate resources to support operations through 2026. (biospace.com)) The company said it received a favorable preliminary FDA bioequivalence determination for its preservative‑free ketamine program and is targeting regulatory approval of at least one product via an ANDA in Q3 2026. (biospace.com)) NRx described a Type C in‑person meeting with the FDA’s Division of Psychiatry Products and CDER to map a path for NRX‑100 (preservative‑free ketamine) under a New Drug Application with an indication for severe depression including patients who may have suicidality. (biospace.com)) Company filings state the FDA expressed willingness in meeting minutes to review existing randomized clinical trial data and real‑world evidence as a potential basis for approval without requiring new trials. (biospace.com)) NRx announced the appointment of Prof. Joshua Brown, MD, PhD, (Harvard/Massachusetts General/McLean) as Chief Medical Innovation Officer and said it filed an IND to study NRX‑101 as an enhancer of transcranial magnetic stimulation (TMS), plus work on a sustained‑release D‑cycloserine formulation tied to prior trials showing large effect‑size improvements when combined with TMS. (biospace.com) The Centers for Medicare & Medicaid Services outlined a program to cover up to $500 per year for select hemp‑derived cannabinoid products for Medicare beneficiaries, with implementation described as beginning as early as April 1, 2026. (marijuanamoment.net)) Utah’s HB390, passed by the Legislature and sent to Gov. Spencer Cox, would authorize the Huntsman Mental Health Institute to conduct controlled clinical trials of psychedelics — including psilocybin, MDMA and DMT — for veterans with treatment‑resistant PTSD, requires funding matches or appropriations, anticipates trial start by January 1, 2027, and mandates FDA IND and DEA authorization compliance. (marijuanamoment.net))
