Two Years After Its FDA Rejection, MDMA Therapy Quietly Comes Back
Resilient Pharmaceuticals — the company formerly known as Lykos, and before that MAPS PBC — has quietly resubmitted its New Drug Application for MDMA-assisted therapy for PTSD, roughly two years after the FDA's August 2024 rejection. No new Phase 3 trial this time: the filing reportedly leans on a small VA follow-up study, a new cardiac-safety study in healthy volunteers, and an audit of the original trial data addressing the unreported-adverse-events problem that helped sink it the first time. MAPS itself says it has no active role in the filing now. Worth flagging: Resilient hasn't confirmed the resubmission publicly — this is trade reporting citing people familiar with the filing, not a company statement. I go deeper on what this means for the wider patent and regulatory picture here.
Read at MAPS