Compass Pathways executives revealed plans to model their upcoming psychedelic treatment launch after Johnson & Johnson's strategy for Spravato, the ketamine nasal spray, as the FDA considers approval. The move comes as psychedelic therapeutics face a critical juncture following Lykos' failed MDMA therapy approval in 2024.
Definium Therapeutics reported that its oral LSD-based treatment DT120 reduced symptoms of generalized anxiety disorder in a second successful late-stage study, marking the company's third Phase 3 win this year for the candidate.
The FDA indicated openness to innovative approaches for studying psychedelic therapies, including the use of comparators other than placebo, signaling potential regulatory accommodation for this emerging treatment class.
New Zealand's pharmaceutical regulator has approved two psychiatrists to prescribe pharmaceutical-grade MDMA to patients suffering from severe post-traumatic stress disorder, marking a significant shift in mental health treatment policy.
Definium Therapeutics announced its experimental LSD-based pill significantly reduced anxiety symptoms in a late-stage study, meeting the trial's main goal. The results mark the company's second major win in two months and sent shares up more than 20% in premarket trading.
A randomized controlled trial conducted through the NHS in England found that a single dose of psilocybin, the active compound in magic mushrooms, produced significant improvements in depression symptoms among 60 adults with treatment-resistant major depressive disorder compared to placebo, with good tolerability.
Definium Therapeutics reported that a single dose of its LSD-based experimental pill significantly reduced symptoms of major depression in patients in a late-stage trial, sending shares higher. The data brings the drug closer to potential FDA approval.
President Trump signed an executive order directing the FDA to expedite reviews of psychedelic drugs including ibogaine, which has been embraced by combat veterans but remains controversial. The order was signed alongside podcast host Joe Rogan.
President Trump signed an executive order directing the FDA to expedite reviews of breakthrough psychedelic therapies for PTSD, depression, and trauma, and to reevaluate their status as controlled substances. The order targets substances including psilocybin.
