Oct 21, 7:05 AM ET
Roivant and its subsidiary Priovant reported that brepocitinib 45 mg met the primary endpoint and all key secondary endpoints in the two identical Phase 3 CLARITY-1 and CLARITY-2 trials in non-infectious uveitis, with 371 patients enrolled. Priovant plans to file a supplemental New Drug Application for NIU in the first half of calendar 2027, which would be the next step toward a possible new treatment for the condition. The filing furnishes the press release under Regulation FD and contains no financial results.
- Primary endpoint (time to treatment failure) met in CLARITY-1 (N=166) and CLARITY-2 (N=204); 371 patients enrolled in total
- Median time to treatment failure was greater than 48 weeks in both studies, versus about 12 weeks on placebo (p<0.0001 in both)
- Pooled, 62% of brepocitinib patients achieved steroid-free quiescence at Week 48, versus 20% on placebo
- Priovant intends to file the sNDA in the first half of calendar 2027; Roivant investor call set for 8:00 a.m. ET on October 21, 2026
Read the filing on SEC.gov ↗
Aug 6, 7:13 AM ET
Roivant reported a net loss of $290.6 million for the quarter ended June 30, 2026, up from $273.9 million a year earlier, on revenue of $1.4 million versus $2.2 million. Net loss per share narrowed to $0.26 from $0.33, and the net loss attributable to Roivant Sciences Ltd. was $189.8 million versus $223.4 million, while R&D and G&A expenses both rose.
- Net loss per common share was $0.26 versus $0.33 a year earlier; non-GAAP net loss was $243.7 million versus $170.1 million.
- R&D expenses rose $49.1 million to $202.0 million; G&A expenses rose $31.5 million to $165.5 million.
- Roivant repurchased 7.3 million common shares for about $208.7 million in the quarter.
- Cash, cash equivalents, restricted cash and marketable securities were $3.9 billion at June 30, 2026, excluding the $950 million Moderna payment received in July 2026.
Read the filing on SEC.gov ↗
May 20, 7:14 AM ET
Roivant reported fourth-quarter net income attributable to the company of $303 million, compared with a loss of $206 million a year earlier, mainly due to a $770.2 million gain on the Moderna litigation settlement. Q4 revenue fell to $2.5 million from $7.6 million, and the full-year net loss attributable to the company widened to $299.8 million from $172.0 million, so the one-time gain does not reflect a steady operating improvement.
- Q4 ended March 31, 2026: net income attributable to Roivant $303.0 million, or $0.28 diluted per share, versus a loss of $206.5 million ($0.29 per share) a year earlier
- Gain on litigation settlement of $770.2 million; Q4 revenue $2.5 million versus $7.6 million
- Full year: loss from continuing operations $397.9 million versus $729.8 million; net loss attributable to Roivant $299.8 million versus $172.0 million
- Cash, cash equivalents and marketable securities of $4.3 billion as of March 31, 2026; Moderna to pay $950 million in July 2026 with an additional $1.3 billion contingent on an appeal
Read the filing on SEC.gov ↗
Apr 2, 7:00 AM ET
Roivant said its Immunovant unit's two Phase 3 studies of batoclimab in thyroid eye disease failed to meet their primary endpoint, and it started a new Phase 2b/3 trial of brepocitinib in lichen planopilaris at Priovant. The filing also gave preliminary cash and marketable securities of about $4.3 billion as of March 31, 2026, and buybacks of about $109.7 million in the quarter, while the fiscal year audit is still ongoing.
- Immunovant's two Phase 3 batoclimab studies in thyroid eye disease each failed to meet the primary endpoint of at least 2mm proptosis responder rate at Week 24; no new safety signals were identified.
- Priovant began a seamless Phase 2b/3 trial of brepocitinib in lichen planopilaris, with first subjects enrolled in March 2026.
- Preliminary cash, cash equivalents and marketable securities were about $4.3 billion as of March 31, 2026.
- Roivant repurchased 3,956,362 common shares for about $109.7 million (excluding fees and commission) in the three months ended March 31, 2026.
Read the filing on SEC.gov ↗
Briefs are written by AI from the filing text (each brief's own page names the model) and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the model's reading of the filing for shareholders, not a price forecast. Not investment advice.