News Releases

Lykos Therapeutics Statement on Recent FDA Meeting

Last week a team from Lykos Therapeutics led by new interim CEO, Michael Mullette, and new Chief Medical Officer, Dr. David Hough, had a productive meeting with the FDA regarding next steps in bringing midomafetamine capsules to the 13 million Americans who have not had a new PTSD treatment option for nearly 25 years. The meeting resulted in a path forward, including an additional Phase 3 trial, and a potential independent third-party review of prior Phase 3 clinical data. Lykos will continue to work with the FDA on finalizing a plan and we will continue to provide updates as appropriate.

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