Amy Emerson, the CEO of Lykos Therapeutics, has stepped down from her role at the company, the WSJ reported.

This announcement comes nearly a month after the Food and Drug Administration (FDA) rejected Lykos's application for its ecstasy-based therapy intended to treat post-traumatic stress disorder (PTSD).

The company, which had sought approval for its midomafetamine therapy – commonly known as MDMA or Ecstasy – was informed last month that the FDA found insufficient evidence to support the treatment's safety and efficacy.

Leadership Change Amidst FDA Rejection

Effective immediately, Michael Mullette, the company's chief operating officer for the past two years, will take over as interim CEO. Mullette brings a wealth of experience from his previous roles at Moderma and Sanofi.

Emerson, who initially began her association with Lykos's sister nonprofit, the Multidisciplinary Association for Psychedelic Studies (MAPS), in 2003, will transition to a senior adviser role and serve as an observer on Lykos's board until the end of the year.

Emerson's departure marks a significant shift for Lykos, a company that has been a pioneer in psychedelic research. She's been at the helm of the company since its rebranding from MAPS's for-profit spin-off earlier this year.

FDA's Concerns And Lykos's Response

The FDA's decision was influenced by concerns over the adequacy of data supporting the therapy's safety and effectiveness. In response, Lykos has announced plans to conduct additional clinical studies and aims to resubmit its application for approval. The company has also made substantial reductions in its workforce, cutting approximately 75% of its staff.

Recent reports from The Wall Street Journal have cast further scrutiny on Lykos's research. Allegations include overlooked serious side effects among study participants, such as suicidal thoughts and the involvement of therapists who conducted unauthorized MDMA therapy sessions. This led the FDA to broaden its investigation into Lykos's studies.

Psychedelic Therapy's Future And Industry Trends

Despite the setback for Lykos, the broader psychedelic therapy landscape continues to evolve. Other companies are advancing their own research into psychedelic treatments. Compass Pathways PLC (NASDAQ:CMPS), for instance, is in the final stages of studies examining psilocybin, commonly known as magic mushrooms, for treatment-resistant depression.

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