NVS - TG Therapeutics falls as Roche succeeds in Phase 3 trial for multiple sclerosis therapy

2023-07-13 09:29:04 ET

TG Therapeutics ( NASDAQ: TGTX ), the developer of FDA-approved multiple sclerosis therapy Briumvi, lost ~10% pre-market Thursday after Genentech, a unit of Roche ( OTCQX:RHHBY ) ( OTCQX:RHHBF ), said Thursday that its product Ocrevus reached its main goals in a Phase 3 trial.

The Phase 3 OCARINA II trial was designed to evaluate Ocrevus, also known as ocrelizumab, as a twice-a-year 10-minute subcutaneous ( SC ) injection against OCREVUS given by intravenous infusion (IV).

In January, TG Therapeutics ( TGTX ) launched Briumvi for adults with relapsing forms of multiple sclerosis (RMS) as a one- hour infusion after initial dosing.

236 patients with RMS, or primary progressive multiple sclerosis, took part in the OCARINA II trial. Ocrevus subcutaneous formulation was developed using Halozyme's ( HALO ) Enhanze Drug Delivery Technology.

According to its topline data, OCARINA II reached the primary and secondary endpoints, indicating a comparable efficacy profile between the subcutaneous formulation and the IV formulation on brain lesions over 12 weeks.

The safety profile between the two forms of therapy was also comparable, Genentech said. In the U.S., Novartis ( NVS ) also markets its anti-CD20 monoclonal antibody Kesimpta for multiple sclerosis.

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