PODCAST | Regulation

Psychedelic setback, FDA’s platform play & ASCO innovations: a BioCentury podcast

How Lykos MDMA-psychotherapy combination stumbled and why other psychedelic therapies won’t be affected

June 10, 2024 11:23 PM UTC

A snub by an FDA advisory committee for Lykos’ MDMA-psychotherapy combination is unlikely to read through to other psychedelic therapies in the pipeline, BioCentury Executive Editor Selina Koch says on the latest BioCentury This Week podcast.

Koch and her fellow editors discuss the shortcomings of the Lykos Therapeutics PBC product’s clinical development program and why other psychedelics likely won’t face the same hurdles.

BioCentury Washington Editor Steve Usdin assesses FDA’s new platform technology designation, which aims to create a predictable pathway for drug manufacturers to leverage and reuse technologies for multiple products.

And BioCentury’s editors analyze the first-in-human clinical trials described at this year’s American Society of Clinical Oncology (ASCO) meeting. Among the most notable trends in the trial group, says BioCentury’s Lauren Martz, is the shift of new modalities from proof-of-concept hematological malignancy indications into more challenging solid tumor settings.

This episode of BioCentury This Week was sponsored by Nxera Pharma Co. Ltd. For information on opportunities to sponsor The BioCentury Show and the BioCentury This Week podcast, please email