Amy Emerson, who served as the CEO of Lykos Therapeutics, has decided to step down from her position following the recent FDA denial of the company's application for their midomafetamine therapy, also known as MDMA or Ecstasy, aimed at treating PTSD. The rejection was based on the FDA's concerns about the lack of adequate evidence supporting the safety and efficacy of the therapy, prompting Lykos to make significant changes in its leadership and strategy.
In light of Emerson's departure, Michael Mullette, Lykos's chief operating officer for the past two years, has been appointed as the interim CEO. Mullette, with a background in notable pharmaceutical companies like Moderma and Sanofi, brings a wealth of experience to lead the company through this challenging phase. Emerson, on the other hand, will transition to a senior adviser role and continue to serve on Lykos's board until the end of the year, marking an end to her tenure as a pioneer in psychedelic research at the company she has been leading since its restructuring from the sister nonprofit, MAPS, earlier in the year.
The FDA's decision not only had immediate implications on Lykos's leadership but also led to the company announcing plans to conduct further clinical studies and aiming for a resubmission of its application for therapy approval. Additionally, Lykos has downsized its staff significantly, reducing its workforce by about 75%. However, recent reports from The Wall Street Journal have raised concerns about Lykos's research practices, including allegations of serious side effects being overlooked and unauthorized MDMA therapy sessions conducted by therapists involved in the studies. These allegations have prompted the FDA to broaden its investigation into the company's research.