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.
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 recent clinical trial found that a single dose of ketamine increases morning cortisol levels in suicidal patients for up to 24 hours, potentially explaining the drug's rapid antidepressant and anti-suicidal effects. The finding adds to understanding of ketamine's therapeutic mechanisms beyond its original use as an anesthetic.
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.
Researchers have developed engineered mouse models for studying psychedelic drug actions, proposed a new neurobiological theory called 'apical hypercontextualisation' to explain altered perception, and identified psychedelic candidates that may reduce side effects while maintaining therapeutic benefits.
A randomized controlled trial in Germany found that dronabinol, a cannabis-derived THC medication, significantly decreased nightmares in patients with post-traumatic stress disorder in a double-blind study published in Nature Medicine.
Scientists at The University of Texas MD Anderson Cancer Center have discovered common neuroimmune signatures that may explain how rapid-acting antidepressants like ketamine and psychedelics work to reduce symptoms in treatment-resistant depression.
The LiBBY clinical trial found that a combination of CBD and THC rapidly and significantly reduced agitation in hospice-eligible dementia patients, with nearly 90% of participants showing behavioral improvement in the nationwide study.
Eli Lilly is in advanced talks to acquire AtaiBeckley, a psychedelic medicine company, with a deal potentially announced this week. The acquisition underscores growing interest from major pharmaceutical companies in psychedelic therapies.
Compass Pathways reported results from a pivotal study showing its psilocybin-based therapy demonstrated long-lasting benefits for treatment-resistant depression, though investor reaction was mixed as shares fell nearly 10% on the data.
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.
Research published in Nature Communications shows that a 25mg dose of psilocybin induced both acute functional changes (detected via EEG one hour later) and enduring anatomical changes (detected via DTI one month later) in 28 healthy adults experiencing their first psychedelic trip.
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.
