Roivant Sciences (ROIV): Reframing NIU $4.1B opportunity and DM launch supports a $9.7B brepo franchise

研报英文原文证据摘录

Roivant Sciences (ROIV): Reframing NIU $4.1B opportunity and DM launch supports a $9.7B brepo franchise

Goldman Sachs Roivant Sciences (ROIV)

expectations, positioning the drug as a potential first-in-class standard of care for a

disease with no approved therapies.

n Safety profile across the program: The breadth of this development experience

also generates a substantial safety database that de-risks the chronic-use profile

required for NIU. Across the VALOR (DM), BEACON (CS), and broader Ph2 programs,

brepo has been generally well-tolerated, with most adverse events

mild-to-moderate and no unexpected safety signals beyond those anticipated for a

dual TYK2/JAK1 inhibitor. Importantly, no unexpected signals around major adverse

cardiovascular events, thromboembolism, or malignancy have been identified to

date, though these remain class-relevant considerations. While the boxed warnings

associated with JAK inhibitors (e.g., serious infections, thrombosis) will continue to

require vigilance, the consistency of findings across trials and indications provides

confidence that brepo’s benefit-risk profile is compatible with the sustained dosing

required for NIU.

NEPTUNE Ph2 NIU study results

Brepo’s Ph2 NIU data provide strong early validation, with the 45 mg dose showing

steroid-sparing disease control and dose-dependent efficacy across key ocular

endpoints. The Ph2 NEPTUNE trial (NCT05523765) evaluated oral once-daily brepo in

26 patients with active non-anterior NIU, including intermediate, posterior, and

panuveitis, across two doses: 45 mg and 15 mg over 24 weeks. Patients received an

initial high-dose corticosteroid regimen followed by a rapid taper, which we view as

clinically important given that steroid-sparing is central to the NIU treatment paradigm