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.
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.
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.
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.
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.
