# Lykos Therapeutics

**Type:** Pharmaceutical company (formerly MAPS Public Benefit Corporation)
**Focus:** MDMA-assisted therapy for PTSD
**Status:** Post-CRL restructuring (75% staff reduction as of August 2024)

## Overview

Lykos Therapeutics (formerly the public benefit corporation arm of MAPS - Multidisciplinary Association for Psychedelic Studies) developed MDMA-assisted therapy for post-traumatic stress disorder. The company conducted pivotal Phase 3 trials (MAPP1 and MAPP2) that showed statistically significant reductions in PTSD symptoms measured by CAPS-5 scores.

## Regulatory History

### FDA Complete Response Letter (August 9, 2024)

The FDA rejected Lykos's New Drug Application for MDMA-assisted therapy, citing:

1. **Functional unblinding:** MDMA's pronounced psychoactive effects (empathogenic, euphoric) meant participants could reliably identify whether they received active drug or placebo, biasing self-reported outcomes. The FDA Psychopharmacologic Drugs Advisory Committee voted 10-1 that functional unblinding compromised trial validity.

2. **Data reliability concerns:** Systematic documentation issues for abuse-related adverse events and site oversight problems at clinical trial sites.

3. **Cardiovascular risk:** Acute cardiovascular effects (heart rate and blood pressure elevation) raised safety concerns for broader population use.

4. **Insufficient duration data:** Inadequate data to guide clinicians on duration of MDMA's therapeutic effects.

The FDA required an additional Phase 3 study. No resubmission timeline has been announced as of May 2026.

### FDA Advisory Committee Review (June 4, 2024)

- **Benefit-risk vote:** 8-1 adverse
- **Functional unblinding vote:** 10-1 adverse (essentially unanimous that blinding failure invalidated trial methodology)

## Organizational Impact

- Laid off approximately 75% of staff following the Complete Response Letter
- Separated operations from MAPS PBC (nonprofit parent organization)
- Meeting with FDA to request reconsideration and discuss resubmission pathway

## Clinical Trial Program

**Phase 3 Trials:**
- MAPP1 and MAPP2 showed statistically significant PTSD symptom reductions
- Used inert placebo comparator (later identified as methodological flaw)
- Efficacy demonstrated but methodology deemed invalid by FDA

## Timeline

- **2024-06-04** — FDA Psychopharmacologic Drugs Advisory Committee votes 10-1 against approval based on functional unblinding concerns
- **2024-08-09** — FDA issues Complete Response Letter rejecting NDA, requiring additional Phase 3 study
- **2024-08** — Lykos lays off ~75% of staff following CRL
- **2025-09-04** — Complete Response Letter made public

## Sources

- FDA Complete Response Letter, August 9, 2024
- Psychiatric Times coverage, September 2025
- STAT News reporting, October 2025