Immunovant's IMVT-1402 hits primary endpoint in difficult-to-treat rheumatoid arthritis trial

Immunovant reported on November 9, 2026 that its fiscal second quarter and six-month results came alongside new data from a potentially registrational trial of IMVT-1402 in patients with difficult-to-treat rheumatoid arthritis (D2T RA).

In Period 2 of the trial, a randomized withdrawal design that followed an open-label lead-in, IMVT-1402 600 mg met the primary endpoint of ACR20 response at Week 28, with rates of 92.5% versus 75.6% for placebo (p=0.0139).¹ By contrast, participants randomized to the 300 mg dose did not show a difference from placebo, with 75.0% maintaining an ACR20 response at Week 28 (p=0.9426).¹

Secondary measures moved in the same direction: change in Clinical Disease Activity Index and Simplified Disease Activity Index from Period 2 baseline to Week 28 numerically favored the 600 mg dose over placebo, with least squares mean CDAI changes of -0.3 versus +3.1 and SDAI changes of +0.1 versus +3.5.¹ In exploratory analyses not powered for statistical significance, ACR50 response rates at Week 28 were 80.0% for IMVT-1402 600 mg versus 56.1% for placebo, and ACR70 rates were 52.5% versus 36.6%.¹ On safety, IMVT-1402 was generally well tolerated in Period 2, with no serious adverse events, Grade 3 or higher treatment-emergent adverse events, or discontinuations due to adverse events reported in any arm.¹

The company said FDA discussions are planned for later this year to determine the path forward for the registrational program in D2T RA.¹ Separately, citing the evolving Sjögren's disease landscape and recent field data, Immunovant said it expects it is unlikely to advance IMVT-1402 further in that indication beyond the ongoing, fully enrolled Phase 2 trial.¹ Topline data are still expected in 2027 for potentially registrational trials in Graves' disease and myasthenia gravis, and in 2028 for chronic inflammatory demyelinating polyneuropathy.

On the balance sheet, cash and cash equivalents totaled $722.3 million as of September 30, 2026, which the company said provides runway to the potential commercial launch of IMVT-1402 in Graves' disease under its current operating plan.¹