FDA Fast-Tracks Psychedelic Drug Research Following Trump Directive; Psychedelic Drug Makers Gain
Shares of some psychedelic drug companies gained Friday morning after the US Food and Drug Administration said it was launching regulatory actions to back the development of psychedelic therapies to treat mental illness.Cybin (HELP) shares jumped past 4%, Psyence Biomedical (PBM) shares climbed 7%, and Clearmind Medicine (CMND) shares were up 2.4%.The FDA's move builds on President Donald Trump's recent executive order directing the Department of Health and Human Services to accelerate access to treatments for people with serious mental illness, the FDA said.The drugs have the potential to address mental health diseases like treatment-resistant depression, alcoholism and substance abuse, said FDA Commissioner Marty Makary.The agency said it is issuing national priority vouchers to three companies researching psilocybin for treatment-resistant depression, psilocybin for major depressive disorder, and methylone for post-traumatic stress disorder.The agency said it is also allowing an early-phase trial of noribogaine hydrochloride to proceed following an investigational new drug filing. The sponsor is investigating noribogaine to potentially treat alcohol use disorder, the FDA said, adding the move will allow the company developing the new drug, DemeRx NB, to start a phase 1 trial in the US.The agency said it will release final guidance "imminently" to provide recommendations to sponsors developing psychedelic medications.Price: $8.89, Change: $-0.27, Percent Change: -2.90%