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Lead program: FDA Review / NDA Filed

Resilient Pharmaceuticals

Also known as: Lykos Therapeutics, MAPS PBC, MAPS Public Benefit Corporation

San Jose, CA, United States
1 Drug Candidate5 Trials3 Papers

Resilient Pharmaceuticals (formerly Lykos Therapeutics, formerly MAPS PBC) is a US-based public benefit corporation developing MDMA-assisted therapy for PTSD. It was founded in 2014 by MAPS (Multidisciplinary Association for Psychedelic Studies) as a commercial spinout to carry MAPS’ three decades of MDMA research through late-stage trials and regulatory approval. After completing two Phase 3 trials and filing an NDA in 2024, the FDA issued a Complete Response Letter (CRL) in August 2024, citing concerns about functional unblinding, durability of response, safety reporting at two trial sites, and the challenge of blinding psychedelic studies. The CRL requested a third Phase 3 trial. Following the rejection, the company laid off approximately 75% of staff. In May 2025, billionaire investors Antonio Gracias (Gracias Foundation) and Sir Christopher Hohn (TCI Fund) led a $50 million Series B recapitalisation, installing new leadership: CEO Mike Burke and CMO Javier Muniz. Rick Doblin, MAPS’ founder, remains supportive of the new direction. The company rebranded from Lykos Therapeutics to Resilient Pharmaceuticals on 28 August 2025, and continues to negotiate a path to FDA approval for MDMA-assisted therapy for PTSD.

Development Programmes

1

Midomafetamine (MDMA)

MDMA
FDA Review / NDA Filed
PTSD

Midomafetamine (MDMA) capsules for MDMA-Assisted Psychotherapy for PTSD (NDA 215455). Developed by Resilient Pharmaceuticals (formerly Lykos Therapeutics / MAPS PBC). NDA submitted December 2023; FDA granted Priority Review. FDA advisory committee voted 9-2 against approval (June 4, 2024) citing blinding issues and data integrity concerns. Complete Response Letter (CRL) issued August 8-9, 2024 — FDA requested a new Phase 3 trial. No resubmission date announced as of April 2026. Company rebranded from Lykos to Resilient Pharmaceuticals (August 2025).

Programme Tracker

PTSD

Primary: US (FDA)
FDA Review / NDA Filedpaused

Forecast

Phase III started - Approval eventual: 25%

CRL received August 2024. FDA requested a new Phase 3 trial. Company has had multiple FDA meetings (Oct 2024, Jan 2025) but no new trial or resubmission date announced as of April 2026.

Milestones

Regulatory filing submitted

Completed

Actual: Dec 1, 2023

NDA 215455 submitted to FDA for midomafetamine capsules — MDMA-Assisted Psychotherapy for PTSD; FDA accepted and granted Priority Review

Why it matters: First-ever MDMA-AT NDA submission; represented 35 years of research by MAPS and its PBC arm

Watch next: Advisory committee meeting and FDA decision

Lykos Therapeutics — NDA Accepted for MDMA-AT; Priority Review Granted(Press release)[Verified]

Regulatory review accepted

Completed

Actual: Jun 4, 2024

FDA Psychopharmacologic Drugs Advisory Committee voted 9-2 against recommending approval, citing functional unblinding, data integrity issues, cardiovascular safety concerns, and prior MDMA use by participants

Why it matters: Adcom negative vote was a major setback; provided FDA a basis for CRL and highlighted fundamental challenges of blinding in psychedelic trials

Watch next: Final FDA decision (CRL issued August 2024)

FDA Adcom Votes 9-2 Against MDMA-AT Approval (NPR)(Regulatory filing)[Verified]

Regulatory rejected

Completed

Actual: Aug 9, 2024

FDA issued Complete Response Letter (CRL) for NDA 215455: deficiencies cited include (1) failure to capture positive adverse events, (2) insufficient durability data, (3) high prior MDMA use in trial participants. FDA requested a new Phase 3 trial before resubmission.

Why it matters: CRL reset the development timeline significantly; a new Phase 3 trial would take several years. Company restructured (cut 75% of staff) and rebranded to Resilient Pharmaceuticals.

Watch next: New Phase 3 trial design, FDA Type B meeting, NDA resubmission timeline

FDA Complete Response Letter — NDA 215455 MDMA-AT (CRL PDF)(Regulatory filing)[Verified]

Company milestone

Completed

Actual: Aug 1, 2025

Lykos Therapeutics rebranded to Resilient Pharmaceuticals; new leadership (CEO Mike Burke, CMO Javier Muniz); company committed to continuing MDMA-AT development for PTSD

Why it matters: Rebrand signals strategic reset; new leadership team focused on addressing FDA deficiencies and designing a new Phase 3 trial

Watch next: New Phase 3 protocol design and FDA alignment on requirements

Lykos → Resilient Pharmaceuticals Rebrand (Psychedelic Alpha)(Press release)[Verified]

Recorded Events

Aug 1, 2025: Company milestone

Aug 9, 2024: Regulatory rejected

Jun 4, 2024: Regulatory review accepted

Dec 1, 2023: Regulatory filing submitted

Evidence Links

Resilient Pharmaceuticals — Company Website

company-website - Resilient Pharmaceuticals - Verified

Quick Facts

Type
biotech
Founded
2014
Lead Stage
FDA Review / NDA Filed
HQ
San Jose, CA, United States

Sponsored Trials

4
CompletedIII

A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD

Start Date
Compounds
MDMA
CompletedIII

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)

Start Date
Compounds
MDMA, Placebo
CompletedIII

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)

Start Date
Compounds
MDMA, Placebo
CompletedII

Randomized, Double-blind, Active Placebo-Controlled Pilot Study of MDMA-assisted Psychotherapy in People With Chronic PTSD

Start Date
Compounds
MDMA

Collaborated Trials

1
CompletedNA

Stanford Reward Circuits of the Brain Study – MDMA

Start Date
Compounds
MDMA, Placebo

Research Papers

3
PaywallindividualPrimary

MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial

This multi-site, randomised, double-blind, Phase IIIb trial (n=104) evaluated the efficacy and safety of MDMA-assisted therapy (MDMA-AT) for individuals with moderate to severe PTSD. The study found significant reductions in PTSD severity (CAPS-5 score) and functional impairment (SDS score) for the MDMA-AT group compared to placebo with therapy. Seven participants experienced severe treatment-emergent adverse events, but no deaths or serious adverse events were reported. The treatment was found to be generally well tolerated in a diverse population.

Published
Journal
Nature Medicine
Authors
Mitchell, J., Ot’alora G, M., van der Kolk, B., Shannon, S., Bogenschutz, M. P., Gelfand, Y., Paleos, C., Nicholas, C. R., Quevedo, S., Balliett, B., Hamilton, S., Mithoefer, A. T., Kleiman, S., Parker-Guilbert, K., Tzarfaty, K., Harrison, C., de Boer, A., Doblin, R., Yazar-Klosinski, B.
Open AccessindividualPooled analysis

Long-term Follow-Up Outcomes of MDMA-assisted Psychotherapy for Treatment of PTSD: A Longitudinal Pooled Analysis of Six Phase 2 Trials

Pooled analysis of six phase 2 trials found that two to three MDMA‑assisted psychotherapy sessions produced large reductions in PTSD severity at 1–2 months (LS mean change −44.8; Cohen’s d = 1.58) with further small but significant improvement at least 12 months post‑treatment (LS mean change −5.2; d = 0.23). The proportion no longer meeting PTSD criteria rose from 56% at treatment exit to 67% at long‑term follow‑up, most participants reported lasting benefits (improved relationships and well‑being) and only a minority reported harms; phase 3 trials are underway to confirm these results.

Published
Journal
Psychopharmacology
Authors
Jerome, L., Feduccia, A. A., Wang, J. B., Hamilton, S., Yazar-Klosinski, B., Emerson, A., Mithoefer, M. C., Doblin, R.
Open Accessmeta

Breakthrough for trauma treatment: safety and efficacy of MDMA-assisted psychotherapy compared to paroxetine and sertraline

This review (2019) details the potential superiority of MDMA-assisted psychotherapy as a treatment for PTSD compared to the conventional treatment options paroxetine and sertraline.

Published
Journal
Frontiers in Psychiatry
Authors
Feduccia, A. A., Jerome, L., Yazar-Klosinski, B., Emerson, A., Mithoefer, M. C., Doblin, R.