Lykos Therapeutics announces FDA acceptance and priority review of new drug application for MDMA assisted therapy for PTSD

MAPS Public Benefit Corporation

9 February 2024 - PDUFA date is 11 August 2024.

Lykos Therapeutics (formerly MAPS Public Benefit Corporation) announced that the US FDA has accepted its new drug application  for midomafetamine capsules used in combination with psychological intervention, which includes psychotherapy and other supportive services provided by a qualified healthcare provider for individuals with post-traumatic stress disorder.

Read Lykos Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier