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Form 8-K · Current Report · Filed 2025-09-17

Roivant Announces Positive Phase 3 Results for Brepocitinib in Dermatomyositis

Roivant Sciences Ltd. announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM). The study demonstrated clinically meaningful and statistically significant improvement over placebo on the primary endpoint and all nine key secondary endpoints, including measurements of skin disease, muscle disease, steroid-sparing effect, and rapidity of onset. The positive results will support an NDA filing for brepocitinib in DM planned for the first half of 2026. Roivant also posted a presentation on its investor relations website and hosted a conference call to discuss the results.

Filer
Roivant Sciences Ltd ROIV · NASDAQ
Filed
Accession
0001140361-25-035190
CIK
0001635088
Signal
Low impactHealthcare

Items reported

Item 7.01

Regulation FD Disclosure

Regulation FD Disclosure
Item 8.01

Other Events

Corporate Update

Market reaction

Close before filing

$14.18

Next session

+6.4%

Since filing

+144.3%

Latest close

$34.64

What happened, not what will happen — closing prices around the filing date.

Precedent

Previous filings from ROIV reporting the same item, with the next session's move:

Roivant Announces Six-Month Remission Data for Graves' Disease Therapy+1.5%
Roivant Sciences Ltd. Announces New $500 Million Share Repurchase Program+0.5%
Immunovant Leadership Changes and New IMVT-1402 Indications Announced+2.7%
Roivant Announces Positive Results for Batoclimab in MG and CIDP Studies+2.4%
Roivant Sciences Announces Topline Results from Phase 2 RESOLVE-Lung Study of Namilumab-3.0%

About Roivant Sciences Ltd

Roivant Sciences Ltd is a biopharmaceutical company focused on developing and commercializing innovative therapies through a unique model that emphasizes rapid and efficient drug delivery. As a platform company, Roivant Sciences incubates subsidiaries known as 'Vants,' each concentrating on a specific therapeutic area. This model allows Roivant to prioritize development of pharmaceuticals in critical areas, including neurology, oncology, immunology, and others. Roivant’s approach facilitates agility in drug development, enabling each Vant to operate semi-autonomously to accelerate research and commercialization efforts. By leveraging technology and data analytics, Roivant enhances drug discovery processes and optimizes clinical trials. In the pharmaceutical industry, Roivant Sciences represents a forward-thinking entity that addresses unmet medical needs by transforming the traditional paradigms of drug development. Its initiatives have substantial implications for healthcare, potentially altering treatment landscapes and improving patient outcomes globally. Founded in 2014 and headquartered in New York City, Roivant is a notable example of innovation-driven pharmaceutical enterprise in the financial market.

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