Lykos does not resubmit its MDMA NDA before year-end; any refiling requires a new confirmatory trial commitment.

Lykos Therapeutics, the company trying to get MDMA-assisted therapy approved in the US, is unlikely to resubmit its application to the FDA (the US drug regulator) before the end of 2025. To even try again, they'd need to commit to running a whole new confirmatory study — a massive, expensive undertaking. This matters because it means MDMA therapy stays out of legal medical settings for longer.

The CRL bar hasn't moved and today's signals show no functional-unblinding remedy. Doblin's presence in hot entities is narrative, not data.