Lykos Therapeutics
the FDA rejected its New Drug Application for MDMA-assisted therapy for PTSD in August 2024 following an advisory committee review; the company restructured, cutting roughly 75% of its workforce, and as of a May 2026 status update remains focused on addressing the FDA's concerns rather than holding an approval.
- Country
- United States
mdma-therapy
us
Coverage
| CN | EU | US | |
|---|---|---|---|
| therapeutics-platforms | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Psychedelic medicine & neuropsychiatric biologics | therapeutics-platforms | High | → |
Compiled by BIOECON via the bioecon-brief pipeline.
Compliance
Bioecon is an information intermediary; it is not a regulator, a certification body, or a legal advisor. When working with public-sector customers (procurement under 44-FZ / 223-FZ), Bioecon acts solely as an independent analytical platform, with no remuneration from suppliers.