Immunovant Narrows Loss After IMVT-1402 RA Result

The Tip Desk · November 9, 2026 · 3 min read

The clinical-stage immunology company posted a $97.2 million net loss, or $0.47 a share, for the quarter ended September 30, 2026, as IMVT-1402 600 mg met its Week 28 ACR20 endpoint in difficult-to-treat rheumatoid arthritis.

Immunovant (IMVT), a clinical-stage immunology company and majority-owned subsidiary of Roivant, reported a net loss of $97.2 million, or $0.47 a share, for the three months ended September 30, 2026, compared with a $153.2 million loss, or $0.75 a share, in the prior quarter. Non-GAAP net loss was $84.0 million.

The quarter’s defining clinical update was Period 2 of the potentially registrational trial of IMVT-1402 in patients with difficult-to-treat rheumatoid arthritis. After an open-label lead-in in which 170 participants received IMVT-1402 600 mg for 16 weeks, 117 participants who met ACR20 criteria at Weeks 14 and 16 were randomized to IMVT-1402 600 mg (n=40), IMVT-1402 300 mg (n=36), or placebo (n=41). IMVT-1402 600 mg met the primary endpoint of ACR20 response at Week 28, with 92.5% versus 75.6% on placebo (p=0.0139). Participants on IMVT-1402 300 mg did not show a difference from placebo, with 75.0% maintaining an ACR20 response (p=0.9426).

Secondary endpoints numerically favored the 600 mg dose. Least-squares mean CDAI changes from Period 2 baseline to Week 28 were −0.3 for IMVT-1402 600 mg and +3.1 for placebo (p=0.1096); SDAI changes were +0.1 versus +3.5 (p=0.1299). In exploratory analyses, ACR50 response at Week 28 was 80.0% for IMVT-1402 600 mg versus 56.1% for placebo, and ACR70 was 52.5% versus 36.6%; the trial was not powered for those measures. The company said IMVT-1402 was generally well tolerated in Period 2, with no serious adverse events, Grade 3 or higher treatment-emergent adverse events, or adverse events leading to discontinuation in any arm. FDA discussions are planned for later this year to determine the path forward for the registrational program in D2T RA.

Research and development expenses were $85.0 million for the three months ended September 30, 2026, compared with $114.2 million a year earlier. The company said the decrease was primarily due to the wind-down of batoclimab clinical trials and lower costs from IMVT-1402 activities, driven by the timing of contract manufacturing costs. Non-GAAP R&D expenses were $78.5 million. General and administrative expenses were $19.1 million, which the company attributed primarily to higher investments in pre-commercial activities; non-GAAP G&A was $12.4 million.

Cash and cash equivalents totaled $722.3 million as of September 30, 2026, down from $797.8 million at June 30, 2026. The company said that balance provides runway to the potential commercial launch of IMVT-1402 in Graves’ disease, based on its current operating plan. Common shares outstanding were 206,785,540.

Immunovant said it is unlikely to advance IMVT-1402 further in Sjögren’s disease beyond the ongoing, fully enrolled Phase 2 trial, citing the evolving SjD landscape and recent data in the field. That marked a shift from the prior quarter’s statement that all IMVT-1402 timelines, including SjD, remained on track. All other clinical development timelines remain on track. The company expects topline data across potentially registrational trials of IMVT-1402 in Graves’ disease and myasthenia gravis in calendar year 2027, and topline data for the potentially registrational trial in chronic inflammatory demyelinating polyneuropathy in calendar year 2028.