Change of CEO next for rejection-rocked Lykos

California’s Lykos Therapeutics is still trying to regroup after being rocked by the US Food and Drug Administration’s (FDA) rejection of midomafetamine (MDMA) capsules for the treatment of post-traumatic stress disorder (PTSD).

This summer, Lykos was hoping to secure a pioneering approval for the entactogen - a class of psychoactive compounds that are differentiated from classic and are defined based on their mechanism and demonstrated effects of increasing self-awareness leading to introspection and personal reflection.

But it all unravelled as the FDA issued a complete response letter after the agency’s Psychopharmacologic Drugs Advisory Committee had earlier voted against MDMA-assisted therapy for PTSD, citing concerns about safety, cardiovascular risks, and issues related to functional unblinding in trial settings.