Jefferies sees raised uncertainty around psychedelic approvability after panel

Jefferies analyst Andrew Tsai notes that an FDA Advisory Committee panel, or AdCom, voted negatively on Lykos’ racemic MDMA having adequate data to demonstrate effectiveness in PTSD and the committee felt MDMA plus a REMS program does not outweigh the risks at this point. While noting that there are differences between Lykos’ trial and other psychedelic programs and many of Lykos’ issues “appear idiosyncratic,” the analyst sees “some increased uncertainty” around the approvability of psychedelics following the results of the panel. With that said, the committee did seem receptive to the therapeutic potential of MDMA and psychedelics in general, added the analyst. Other companies working on psychedelic drugs included Mind Medicine (MNMD), Cybin (CYBN), Compass Pathways (CMPS) and Atai Life Sciences (ATAI).