Roivant Sciences Ltd. ROIV
Roivant Sciences Ltd. (Nasdaq: ROIV) is an immunology/inflammation drug developer. Its lead program, brepocitinib, is in Phase 3 for dermatomyositis. Its next catalyst on record is IMVT-1402 (CLE): Phase 2 data (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: IMVT-1402 (CLE) — Phase 2 data (H2 2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| brepocitinib | dermatomyositis (NDA under FDA review) | small molecule | Phase 3 |
| brepocitinib | non-infectious uveitis (Phase 3 CLARITY) | small molecule | Phase 3 |
| brepocitinib | cutaneous sarcoidosis (Phase 3) | small molecule | Phase 3 |
| IMVT-1402 | Graves' disease, myasthenia gravis, CIDP, Sjogren's, others | antibody | Phase 3 |
| brepocitinib | lichen planopilaris (Phase 2b/3) | small molecule | Phase 2 |
| IMVT-1402 | cutaneous lupus erythematosus (Phase 2) | antibody | Phase 2 |
| mosliciguat | pulmonary hypertension associated with ILD (Phase 2) | small molecule | Phase 2 |
Recent results and decisions
- Oct 21, 2026met CLARITY-1 met its primary endpoint of time to treatment failure: HR 0.27 (95% CI 0.17-0.43), week-48 failure 35.4% vs 78.7% on placebo, p<0.0001; all key secondaries significant.
Brepocitinib 45 mg once-daily achieved statistically significant benefit compared to placebo on the primary and all key secondary endpoints for each of CLARITY-1 and CLARITY-2, the two identical Phase 3 trials comprising the CLARITY program in NIU
Filing - Sep 8, 2026met Phase 2 PHocus met its primary endpoint with a placebo-adjusted PVR reduction of 56.3% at Week 16 (p<0.0001); 6MWD +35.2 m and NT-proBNP -53.2% also significant.
The PHocus study met its primary endpoint, demonstrating a clinically meaningful and statistically significant placebo-adjusted reduction in PVR of -56.3% (-51.3% mosliciguat vs. +6.6% placebo, p<0.0001) at Week 16.
Filing - Sep 8, 2026started Phase 3 PHrontier study of mosliciguat in PH-ILD has been initiated with enrollment underway (about 375 patients planned).
Phase 3 PHrontier study of mosliciguat in patients with PH-ILD has been initiated, with enrollment underway
Filing
4 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 immunology/inflammation companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.