Roche (OTCQX:RHHBY) shares closed ~4% higher in Europe on Monday as the maker of Ocrevus multiple sclerosis therapy announced two Phase 3 trial successes for fenebrutinib, its new experimental drug for the central nervous system (CNS) disorder.
The Swiss drugmaker said fenebrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, reached the primary endpoint in FENhance 2, the first of two Phase 3 trials similarly designed to evaluate fenebrutinib in patients with relapsing MS.
Additionally, the company announced that fenebrutinib, an oral, central nervous system (CNS)-penetrant, was found to be non-inferior to Ocrevus (ocrelizumab) in its Phase 3 FENtrepid pivotal study, which tested it against the non-oral medication.
The experimental therapy indicated a safety profile in line with its prior studies, according to Roche (OTCQX:RHHBF), which, however, said that further analysis of safety data is currently underway. TG Therapeutics (TGTX), the developer of the FDA-approved MS therapy Briumvi, fell ~7% after the readout.
Roche (OTCQX:RHHBY) expects to report data from FENhance 1, its second RMS Phase 3 trial for fenebrutinib, by H1 2026.