Reunion Neuroscience
Reunion Neuroscience is a private, Toronto-based clinical-stage biopharmaceutical company focused on short-duration, serotonergic psychedelic therapies for postpartum depression, adjustment disorder, and anxiety. Spun out of Field Trip Health in 2022, the company raised a $103M Series A in May 2024 (co-led by Novo Holdings and MPM BioImpact) and went private under CEO Greg Mayes. Its lead asset RE104 (luvesilocin) — a subcutaneous prodrug of 4-OH-DiPT, a psilocybin-like 5-HT2A agonist with shorter duration than psilocybin — met the primary endpoint of its RECONNECT Phase 2 trial for PPD (Aug 2025) and received FDA Breakthrough Therapy Designation on February 23, 2026. A single pivotal Phase 3 trial is planned for 2026.
Development Programmes
4RE104 (luvesilocin)
PsilocybinRE104 (luvesilocin) is a subcutaneously administered prodrug of 4-OH-DiPT (a serotonin 2A agonist) producing a ~4-hour psilocybin-like psychedelic experience. Lead indication: postpartum depression (PPD). RECONNECT Phase 2 (NCT06342310, n=84): positive topline August 2025 — statistically significant MADRS reduction of 23.0 pts at Day 7 (p=0.0094). FDA Breakthrough Therapy Designation granted February 2026. Phase 3 RECONNECT Phase 3 planned 2026 following successful EOP2 meeting (December 2025).
Programme Tracker
Peripartum
Forecast
Phase III started - Approval eventual: 50%
Phase 3 single pivotal trial planned for 2026 initiation. FDA indicated one Phase 3 trial + BTD support is sufficient for potential NDA registration in PPD.
Milestones
Phase II started
CompletedActual: Jul 23, 2024
First patient dosed in RECONNECT Phase 2 (NCT06342310, 38 US sites, 84 patients)
Why it matters: Initiates the pivotal Phase 2 in an under-served indication (PPD affects ~1 in 7 women post-birth)
Watch next: Enrollment completion and topline results
Phase II topline
CompletedActual: Aug 18, 2025
RECONNECT Phase 2 topline results: statistically significant primary endpoint met — MADRS reduction 23.0 pts at Day 7 (30 mg arm) vs 17.2 pts (1.5 mg control; p=0.0094). Effects observed at Day 1, maintained through Day 28. No serious adverse events.
Why it matters: Clear proof-of-concept in PPD — a significant unmet need; rapid onset (Day 1) differentiates RE104 from standard antidepressants which take weeks
Watch next: EOP2 meeting with FDA and Phase 3 launch
Phase III started
PlannedLikely: Q3 2026
Phase 3 single pivotal trial planned for 2026; FDA indicated one additional Phase 3 trial is sufficient for potential NDA registration following positive EOP2 meeting (December 2025)
Why it matters: Single pivotal trial path minimises risk and cost; if successful, this could be the first psychedelic medicine approved for PPD
Watch next: Phase 3 ClinicalTrials.gov registration and first patient dosing
Regulatory review accepted
CompletedActual: Feb 23, 2026
FDA granted Breakthrough Therapy Designation to luvesilocin (RE104) for PPD
Why it matters: BTD accelerates development and provides intensive FDA guidance; validates luvesilocin's profile in PPD and strengthens Phase 3 design
Watch next: Phase 3 initiation (2026)
Recorded Events
Feb 23, 2026: Regulatory review accepted
Aug 18, 2025: Phase II topline
Jul 23, 2024: Phase II started
Evidence Links
trial-registry - ClinicalTrials.gov - Verified
Press release - Reunion Neuroscience - Jan 12, 2026 - Verified
RE104 (luvesilocin)
PsilocybinRE104 (luvesilocin) for adjustment disorder (AjD) in adults with cancer and other serious medical illnesses. Phase 2 REKINDLE study (NCT07002034): single SC dose, randomised double-blind, primary endpoint MADRS change at Day 14. Announced at ADAA 2025 conference. Enrollment initiation expected Q3 2025.
Programme Tracker
Palliative & End-of-Life Distress
REKINDLE Phase 2 (NCT07002034) enrolling; enrollment initiation targeted Q3 2025
Milestones
Phase II started
CompletedActual: Apr 7, 2025
REKINDLE Phase 2 (NCT07002034) presented at ADAA 2025; study evaluates RE104 in adjustment disorder in cancer and other serious illness
Why it matters: AjD in cancer patients is an under-served and sympathetic regulatory indication with precedent for expedited review
Watch next: Enrollment milestone and topline data
Recorded Events
Apr 7, 2025: Phase II started
Evidence Links
trial-registry - ClinicalTrials.gov - Verified
RE104 (luvesilocin)
PsilocybinRE104 (luvesilocin) for generalised anxiety disorder (GAD). Phase 2 RECLAIM study expected to commence Q1 2026. No NCT number yet registered as of April 2026.
Programme Tracker
Anxiety Disorders
RECLAIM Phase 2 expected Q1 2026 initiation per company's January 2026 programme update
Milestones
Phase II started
PlannedLikely: Q1 2026
RECLAIM Phase 2 in GAD planned; announced as an anticipated 2026 milestone in January 2026 programme update
Why it matters: GAD is a large indication; positive signal here combined with PPD Phase 3 data would significantly broaden RE104's commercial potential
Watch next: ClinicalTrials.gov registration and first patient dosing
RE245
RE245 is a non-psychedelic, orally bioavailable serotonin 2A (5-HT2A) agonist neuroplastogen designed for chronic treatment paradigms. Structurally related to classic psychedelics but engineered to deliver 5-HT2A-mediated neuroplasticity without hallucination or cardiotoxicity. IND-enabling studies planned 2025; IND application targeted 2026.
Programme Tracker
Depressive Disorders
IND-enabling studies planned for 2025; IND application targeted 2026
Milestones
Discovery completed
CompletedActual: Jan 6, 2025
RE245 preclinical programme disclosed publicly; non-psychedelic 5-HT2A agonist for chronic oral dosing paradigm
Why it matters: Non-psychedelic profile could address a much larger patient population who cannot or will not access supervised psychedelic therapy
Watch next: IND-enabling study completion and IND submission
Recorded Events
Jan 6, 2025: Discovery completed
Quick Facts
- Type
- Private Biotech
- Founded
- 2020
- Lead Stage
- Phase III
- HQ
- Toronto, Ontario, Canada, Canada
- Website
- Visit