01—Abstract
Summary
Summary of the 8-K filed September 17, 2025. Cited figures are marked; the original filing is the authoritative source.
Roivant Sciences Ltd. (ROIV) furnished an 8-K on September 17, 2025 announcing positive results from the Phase 3 VALOR study of brepocitinib in dermatomyositis (DM), conducted at its subsidiary Priovant Therapeutics.
On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 versus 31.2 for placebo (p=0.0006). The company states the result is the first positive outcome for a 52-week placebo-controlled trial in DM and the first positive registrational trial for a targeted therapy in DM. Brepocitinib 30 mg also showed statistically significant improvement over placebo on all nine key secondary endpoints, and the 15 mg and 30 mg arms showed a consistent dose response.
The filing reports that 62%a of brepocitinib 30 mg patients on background steroids reached a steroid dose of 2.5 mg/day or less by the end of the study, versus 34% on placebo, and 42% came off steroids altogether versus 23% on placebo. Adverse events of special interest, including malignancy, cardiovascular events and thromboembolic events, did not occur more frequently on 30 mg than on placebo. Priovant plans to file a New Drug Application (NDA) in the first half of 2026.
Roivant also posted a presentation for an 8:00 a.m. EDT investor call on September 17, 2025, and attached it as Exhibit 99.2. The presentation notes an upcoming Roivant investor day on December 11, 2025, and ties the DM readout to a planned FDA filing in 1H 2026.
02—Key points
Key Highlights
- Primary endpoint: week 52 mean TIS of 46.5 for brepocitinib 30 mg vs. 31.2 for placebo (p=0.0006)
- All nine key secondary endpoints met statistical significance vs. placebo, per the press release
- Steroid reduction: 62% of 30 mg patients on background steroids reached 2.5 mg/day or less vs. 34% on placebo; 42% came off steroids vs. 23% on placebo
- Response depth: more than two-thirds achieved TIS≥40 (moderate response) and nearly half achieved TIS≥60 (major response)
- Safety consistent with prior brepocitinib trials; AESIs did not occur more often on 30 mg than placebo
- NDA filing for brepocitinib in dermatomyositis planned for the first half of 2026
- Roivant describes VALOR as the 12th consecutive positive Phase 3 study for the company
03—Questions
Frequently Asked Questions
What did the VALOR study measure and what were the primary results?
VALOR was a 52-week, randomized (1:1:1) placebo-controlled Phase 3 study of 241 adults with dermatomyositis. The primary endpoint was the week 52 difference in mean Total Improvement Score (TIS). Brepocitinib 30 mg scored 46.5 versus 31.2 for placebo (p=0.0006).
What is the regulatory timeline for brepocitinib in dermatomyositis?
Priovant plans to file a New Drug Application (NDA) for brepocitinib in dermatomyositis in the first half of 2026. The filing states that the product candidate is investigational and subject to regulatory approval.
How did the safety profile compare between brepocitinib and placebo?
The company said the safety profile was consistent with previous brepocitinib trials. Adverse events of special interest, including malignancy, cardiovascular events and thromboembolic events, did not occur more frequently in the 30 mg arm than in the placebo arm. The presentation reports zero deaths in all arms.
How does this result relate to Roivant's ownership of Priovant?
The investor presentation states that Roivant owned 74% of Priovant as of June 30, 2025 (65% on a fully diluted basis), with Pfizer owning 25%. Priovant holds commercial rights to brepocitinib in the US and Japan.
04—Continue