Lykos Therapeutics Cuts 75% of Staff After FDA Rejection of MDMA Treatment for PTSD ###

Staff Reduction:
Lykos Therapeutics announced it will cut 75% of its staff following the FDA's rejection of its MDMA treatment for post-traumatic stress disorder (PTSD).

FDA Decision:
The FDA rejected Lykos' application for midomafetamine (MDMA) capsules, requesting an additional Phase 3 trial to evaluate the drug's safety and efficacy.

Reorganization:
The remaining staff will focus on ongoing clinical development, medical affairs, and engagement with the FDA. Dr. David Hough, a former J&J executive, has been appointed as senior medical advisor to oversee these efforts.

Board Changes:
Dr. Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), has stepped down from Lykos' board to advocate more freely for MDMA.

Ethical Concerns:
The FDA's rejection was influenced by ethical concerns and efficacy issues raised by the Psychopharmacologic Drugs Advisory Committee. Additionally, three papers about MDMA-assisted psychotherapy were retracted due to data integrity concerns and unethical conduct.

Future Plans:
Lykos plans to request a meeting with the FDA to discuss the decision and seek recommendations for resubmission. The company remains committed to bringing the MDMA treatment to market.