Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Roluperidone (5-HT2A antagonist) in Schizophrenia. The expected timing is based on the latest available company guidance and may change.
5/10/23- Accepted NDA, PDUFA on February 26, 2024. 2/27/24- Received CRL. 5/13/25- Ongoing interaction w/ FDA to address queries raised in the CRL. 11/05/25:- Completed $80M private placement with added warrant funding tied to Ph3 primary endpoint success. Aligned with FDA on confirmatory Ph3 trial; timing for trial start and NDA resubmission remains TBA. 01/26/26:- Plans confirmatory Ph3 roluperidone trial start in 2026 using FDA-aligned protocol focused on negative schizophrenia symptoms. 03/11/26:- Confirmatory Ph3 trial initiation expected Q2 2026; 12-week primary endpoint data expected 2H 2027. 03/25/26:- Open label safety trial showed no significant issues with olanzapine. Confirmatory Ph3 enrolling; topline data expected H2 2027. 03/31/26:- First patient screened in MIN-101C19 confirmatory Ph3. Topline 12-week efficacy data expected H2 2027. 05/05/26:- MIN-101C19 confirmatory Ph3 enrolling; SIRS 2026 open-label data showed no safety concerns; topline remains H2 2027. 08/07/26:- C19 Ph3 is ongoing. Phase A data are due H2 2027 and Phase B data H2 2028.
Verification
Confirm timing and program details against the company announcement or filing.