Clinical trialsCompany release

Immunovant's IMVT-1402 meets primary endpoint in difficult-to-treat RA trial at 600 mg

🇺🇸 Immunovant, Inc. (IMVT) · Mon 09 Nov 2026

The 600 mg dose beat placebo on ACR20 at Week 28, but 300 mg did not separate; Immunovant also says further Sjögren's development beyond Phase 2 looks unlikely.

Immunovant reported on 9 November 2026 that IMVT-1402 600 mg met the primary endpoint in the randomized-withdrawal period of its potentially registrational trial in difficult-to-treat rheumatoid arthritis (D2T RA). The endpoint was ACR20 response at Week 28.

In that period, 92.5% of patients on the 600 mg dose achieved ACR20, against 75.6% on placebo. The 300 mg dose did not separate from placebo.

The company plans to discuss the registrational path in D2T RA with the US Food and Drug Administration later this year. The source does not detail what the discussions will cover.

Immunovant also said it now considers further development of IMVT-1402 in Sjögren's disease, beyond the ongoing Phase 2 study, to be unlikely.

On finances, the company reported cash of $722.3 million at quarter-end and a net loss of $97.2 million for the quarter ended 30 September 2026.

What it means for your team

  • Only the 600 mg dose showed a separation from placebo, so dose selection will likely be a central question in any FDA discussion on the registrational path.
  • The FDA meeting planned for later this year will determine whether the current trial can support a filing; regulatory teams should watch for the outcome.
  • The reported Sjögren's de-prioritisation narrows the near-term indication portfolio for IMVT-1402 and may matter for competitors' and payers' pipeline planning in autoimmune disease.

Company's press release (SEC filing): Immunovant, Inc. ↗

Article written by VigiEye from the official source (Immunovant, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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