FDA Grants Quick Review Psychedelic Drugs, First Approvals Could Come As Soon As Summer
The FDA announced new steps to speed up research on psychedelic treatments for serious mental health conditions, following an executive order from President Donald Trump directing agencies to expand access to emerging therapies, CNBC and NBC reported this morning:
In a press release Friday, FDA commissioner Marty Makary said the medications “have the potential to address the nation’s mental health crisis, including conditions like treatment resistant depression, alcoholism and other serious mental health and substance abuse conditions.” On Monday, Makary told NBC News that with the accelerated application process, the FDA could potentially approve the first psychedelic drug by the end of summer.
The agency said this effort could support new treatments for conditions like treatment-resistant depression, PTSD, and substance use disorders. Measures include prioritizing drugs with early promising results and offering incentives to companies studying compounds such as psilocybin and methylone. It also approved an early clinical trial for noribogaine, marking the first time a drug of its kind will be studied in the U.S.
Officials emphasized that these actions do not mean the treatments are approved or proven safe. All research will be closely monitored to ensure it meets strict scientific and safety standards.
Popular psychedelic names like Compass Pathways and AtaiBeckley have turned positive YTD on on the news out the last few days.
"The executive order I'm signing, we're actually signing the executive order today, is really a moment," Trump said at the signing event days ago. "These treatments are currently in the advanced stages of clinical trials to ensure that they're both safe and effective for the American patients."
Trump's order, signed on Saturday, directs the FDA to prioritize review of certain breakthrough-designated psychedelic therapies, expands potential access under the Right to Try Act, commits at least $50 million in federal funding for state partnerships, and encourages closer coordination among HHS, the FDA, the VA, and private-sector researchers.
"In many cases, these experimental treatments have shown life-changing potential for those suffering from severe mental illness and depression, including our cherished veterans," Trump said, citing the veteran suicide rate.
The order also instructs the Justice Department to move quickly on rescheduling any psychedelic-based product that successfully completes Phase 3 trials and receives FDA approval.
Trump continued, "And the nice part is we're actually doing this early, but it has been going on. Research has been going on for quite some time. But, you know, usually with things like this, nothing ever happens, no matter how the research ends up, but we're changing that. This order will clear away unnecessary bureaucratic hurdles, improve data sharing among the FDA and the Department of Veterans Affairs, and facilitate fast rescheduling of any psychedelic drugs that become FDA-approved."
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