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Form 8-K · Current Report · Filed 2026-08-27

Roivant Sciences Announces FDA Approval of LISRAYA for Dermatomyositis

Roivant Sciences Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved LISRAYA (brepocitinib) for the treatment of adults with dermatomyositis, a rare systemic autoimmune disease. LISRAYA is a once-daily pill that targets key immune pathways implicated in dermatomyositis pathogenesis. The approval follows the landmark Phase 3 VALOR trial, which demonstrated robust efficacy and substantial steroid-sparing benefits. LISRAYA is now available in the U.S., with eligible patients able to pay as little as $0 per month through the LISRAYA My Compass Support program.

Filer
Roivant Sciences Ltd ROIV · NASDAQ
Filed
Accession
0001140361-26-034735
CIK
0001635088
Signal
High impactHealthcare

Items reported

Item events

Reported Item

Regulatory Approval New Major Contract

Market reaction

Close before filing

$36.75

Next session

-5.6%

Since filing

-5.7%

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 Sciences Reports Q1 2026 Financial Results and Business Update+5.0%
Roivant Sciences Announces $2.25 Billion Settlement with Moderna and Reports Q4 2026 Financial Results+9.5%
Roivant Announces New Phase 2b/3 Trial for Brepocitinib in Lichen Planopilaris and Reports Phase 3 Results for Batoclimab in Thyroid Eye Disease+0.1%
Roivant Sciences Ltd. Resolves Patent Litigation with Moderna-3.0%
Roivant Announces $2.25 Billion Settlement with Moderna and New Share Repurchase Program+5.1%

Insider tape

Within 45 days of this filing, ROIV insiders reported 28 Form 4 transactions — net selling of $39.6M.

Full ROIV insider history →

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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