companyBiopharmaceuticals / Psychedelic MedicineUnited States

Lykos Therapeutics

Clinical-stage biopharmaceutical company developing MDMA-assisted therapy for PTSD and other mental health conditions.

Lykos Therapeutics is a public benefit corporation spun out of MAPS (Multidisciplinary Association for Psychedelic Studies) in 2014 and rebranded under its current name in early 2024. Its mission is to transform mental healthcare by advancing investigational psychedelic-assisted therapies, with an initial focus on post-traumatic stress disorder (PTSD). The name "Lykos" — Greek for wolf — was chosen to represent bravery, courage, loyalty, and intelligence.

The company's lead program is midomafetamine (MDMA)-assisted therapy for PTSD. Lykos submitted the first-ever New Drug Application (NDA) for an MDMA-assisted therapy, which the FDA accepted and granted Priority Review with a PDUFA date of August 11, 2024. However, the FDA issued a Complete Response Letter (CRL) in August 2024, declining approval amid advisory committee concerns about safety, cardiovascular risks, and functional unblinding in clinical trials.

Following the regulatory setback, Lykos cut approximately 75% of its staff and saw founding CEO Amy Emerson step down, with COO Michael Mullette taking over as interim CEO and David Hough — formerly involved in J&J's ketamine therapy — elevated to Chief Medical Officer. The company has raised $150 million in total, including a Series A led by Helena Special Investments. Lykos continues to negotiate with the FDA and MAPS continues to support MDMA research and therapist training programs.

For innovators in psychedelic medicine, mental health therapeutics, or drug-assisted therapy platforms, Lykos represents the leading edge of regulatory engagement in this space, making it a critical reference point for understanding the approval landscape and clinical trial design challenges.

Ideas that could help Lykos Therapeutics

MDMA-Assisted PTSD Therapy Network for Veterans and First Responders
A dedicated clinic network delivering the phase-3-validated MDMA-assisted therapy protocol for severe, treatment-resistant PTSD in veterans and first responders, targeting patients with comorbidities who fail existing treatments.
Why it helps: As the sponsor of the phase 3 MDMA-AT trial and holder of the proprietary drug-therapy protocol, Lykos would directly benefit from an affiliated clinical network that deploys its commercialized therapy and generates ongoing real-world outcomes data.