Lykos Therapeutics

Executive Summary

Lykos Therapeutics, formerly MAPS Public Benefit Corporation, is a privately held US biotech company pioneering MDMA-assisted therapy for post-traumatic stress disorder (PTSD). Founded in 2014, Lykos leverages decades of research to develop novel psychedelic treatments, aiming to transform mental healthcare and reduce stigma. The company's lead therapy, MDMA-assisted psychotherapy, demonstrated significant efficacy in Phase 3 trials but received a Complete Response Letter from the FDA in August 2024, requesting additional trial data. Despite this setback, Lykos continues to work closely with regulators, conducting confirmatory studies and preparing a resubmission. The company also explores its therapy's potential in other indications such as anxiety and substance use disorders, leveraging its extensive clinical data and advocacy network.

Upcoming Catalysts (preview)

• H2 2026FDA Resubmission of MDMA-Assisted Therapy NDA40% success
• H1 2027Initiation of Phase 3 Trial for Alcohol Use Disorder60% success
• H2 2026Strategic Partnership or Licensing Deal with Major Pharma45% success