Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for BRIUMVI (ublituximab-xiiy) subcutaneous in Multiple sclerosis. The expected timing is based on the latest available company guidance and may change.
3/3/25- Commence pivotal program based on ENHANCE data. 5/30/25- Presented data update at the 2025 CMSC. 9/8/25- Ph3 trial commenced enrollment. 10/28/25- Enrollment completed. 11/03/25:- Company reiterates advancement of the Ph3 pivotal program of subcutaneous ublituximab; enrollment has been achieved and timing of the Ph3 data readout remains to be determined. 01/27/26:- ENHANCE trial Briumvi biomarker results to be presented at ACTRIMS Forum 2026 poster session. 02/06/26:- ENHANCE multi-protein biomarker results presented at ACTRIMS 2026; Ph3 subcutaneous data timing still undetermined. 02/26/26:- Subcutaneous Ph3 program ~75% enrolled; pivotal topline data expected around Year-End 2026/Q1 2027. 04/15/26:- Ph3 RMS SC Briumvi enrollment complete; topline data still expected YE 2026/Q1 2027. 05/06/26:- Company reiterates SC Ph3 enrollment completion and expects topline data around YE 2026/Q1 2027. 06/03/26:- Ph1 SC PK/PD data positive. Fully enrolled Ph3 SC topline expected late 2026 or early 2027. 06/09/26:- PK bridging studies in MS ongoing; SC dosing in MG Ph2 will be added later. 08/03/26:- SC Ph1 bioavailability exceeded 60%. Ph3 topline expected Year-End 2026/Q1 2027.
Verification
Confirm timing and program details against the company announcement or filing.