Key Takeaways
- Roivant shares jumped 8% today after brepocitinib met the main goal and every key secondary goal in two Phase 3 trials in non-infectious uveitis.
- The results make uveitis a likely second use for a drug already sold as LISRAYA for dermatomyositis, with a filing planned for the first half of 2027.
- In both trials, median time to treatment failure was more than 48 weeks on brepocitinib, compared with about 12 weeks on placebo.
- Roivant reports results on Nov. 9 and holds an investor day on Dec. 9, the next chances to hear how big it thinks the uveitis opportunity is.
Roivant Sciences (ROIV) stock is up 8% this morning. Its subsidiary Priovant said brepocitinib met the primary endpoint and every key secondary endpoint in CLARITY-1 and CLARITY-2, two identical Phase 3 trials in non-infectious uveitis (NIU).
Dr. Quan Dong Nguyen, a Stanford ophthalmology professor and president of the International Ocular Inflammation Society, called them “phenomenal results.”
What exactly happened
The trials enrolled 371 patients for 48 weeks of once-daily treatment. The headline numbers:
- In both trials, median time to treatment failure was more than 48 weeks on brepocitinib, compared with about 12 weeks on placebo.
- Across the two trials together, 62% of patients on brepocitinib were free of active inflammation and off steroids (steroid-free quiescence) at week 48, compared with 20% on placebo.
- In eyes that started with macular edema, 42% saw it resolve, compared with 4.8% on placebo.
And Priovant got there with “a substantially more aggressive steroid taper than precedent NIU trials.” Only 3% of patients quit over a side effect, and there were no new safety signals.
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A second act for brepocitinib
Brepocitinib is already sold as LISRAYA for adults with dermatomyositis. NIU, one of the leading causes of blindness among working-age people, would be its second indication. Priovant estimates it affects 70,000 to 190,000 US adults and plans to file with the FDA in the first half of 2027.
Analysts already expect revenue to climb from $8.26 million in the year ended March 2026 to $1.53 billion in the year ending March 2029 (though only seven analysts estimate that far out).
Those estimates date from Sept. 22. With the filing still months away, uveitis sales could only show up at the far end of them. Today’s data gives analysts reason to raise those later years.
What the market is paying for
Roivant had $3.84 billion of cash and short-term investments at the end of June, down from $5.39 billion in September 2024.
At this morning’s price, Roivant is worth about $25 billion. Take out the cash, and the market is paying roughly $21 billion for brepocitinib and the rest of the pipeline.
The FDA still has to approve the new indication, and LISRAYA carries a boxed warning.
My take: today’s move adds about $2 billion to Roivant’s value. That looks modest for data this strong, in a disease where patients have, as Nguyen put it, “waited nearly a decade for a new systemic, non-steroid treatment option.”
Of course, we’ll hear more when Roivant reports results on Nov. 9 and at its investor day on Dec. 9.
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