NRx Pharmaceuticals
NDA Filed2 active candidates
NDA Filed peersame regulator: US FDAsame country: United Statessimilar active pipeline size
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Lead program: NDA Filed
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1 domain / 2 areas / 1 specialization
Resilient Pharmaceuticals
Also known as: Lykos Therapeutics, MAPS PBC, MAPS Public Benefit Corporation
Data updated
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 as a commercial spinout to carry MAPS MDMA research through late-stage trials and regulatory approval.
After two Phase 3 trials and an NDA filing, FDA issued a Complete Response Letter in August 2024 and requested an additional Phase 3 trial before approval. The company subsequently restructured and rebranded, while the public Lykos web presence continues to describe the organisation as pursuing FDA approval for MDMA-assisted therapy. As of the June 2026 review, no public company announcement of a new pivotal trial start or NDA resubmission date was found. VA/DoD-backed MDMA/PTSD research is proceeding in the broader field, but it should not be treated as direct support for Resilient/Lykos NDA resubmission unless linked by company or FDA evidence.
Pipeline Intelligence
Developer Momentum
- Active candidates
- 1
- Active programmes
- 1
- Lead stage
- NDA Filed
- Forecast coverage
- 1 of 1
All tracked candidates active
All tracked programmes active
Current furthest stage
1 active programme with forecast fields
Latest sourced update
Resilient Pharmaceuticals — Company Website
Jun 27, 2026 - company-website - Resilient Pharmaceuticals - Midomafetamine (MDMA)
Next known catalyst
Phase III started
Timing not specified - Midomafetamine (MDMA) / MDMA-AT PTSD — NDA 215455 (Post-CRL) - Confidence: 35%
5 sources1 pipeline-linked trial2 pipeline-linked papers
Development Programmes
1Midomafetamine (MDMA)
MDMANDA Filed
Midomafetamine (MDMA) capsules for MDMA-assisted therapy for PTSD (NDA 215455). FDA issued a Complete Response Letter in August 2024 and requested a new Phase 3 trial. As of the June 2026 review, public company materials still indicate pursuit of FDA approval, but no new pivotal trial start or NDA resubmission date had been announced.
Programme Tracker
PTSD
Primary: US (FDA)
FDA Review / NDA Filedpaused
Forecast
Phase III started - Approval eventual: 25%
Post-CRL programme remains paused pending a new FDA-aligned Phase 3/resubmission path. Public Lykos materials still describe pursuit of FDA approval, but no new pivotal trial start or resubmission date was found in the June 2026 review.
Milestones
Regulatory filing submitted
CompletedActual: 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
Regulatory review accepted
CompletedActual: 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)
Regulatory rejected
CompletedActual: 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
Company milestone
CompletedActual: 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
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 - Jun 27, 2026 - Verified
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Quick Facts
- Type
- biotech
- Founded
- 2014
- Lead Stage
- NDA Filed
- HQ
- San Jose, CA, United States