Newly announced US FDA advisory committee meetings on Lilly’s Alzheimer’s antibody, Lykos’ pioneering psychedelic therapy for PTSD relieve drought in non-oncology AdComms as the 2024-‘25 COVID vaccine strain selection meeting is postponed.

As Astellas pivots through several candidates in an attempt to create its next blockbuster, a decision to terminate its only prospect in the core mitochondrial R&D area leaves very few other competitors in the market.

Pink Sheet reporter and editors discuss Richard Pazdur’s call for more diverse opinions in FDA advisory committee meeting open public hearings, agency questions about the stakeholders sponsors consult to execute clinical trial diversity plans, and the pending review of Stealth BioTherapeutics’ application for the Barth Syndrome candidate elamipretide.

The Barth Syndrome candidate application will be reviewed by the FDA, but Stealth BioTherapeutics' CEO tells the Pink Sheet that the company still does not have clear guidance on how or whether it should gather additional clinical data.