FDA approval of first at-home therapy for thyroid eye disease signals new market access.
Context
What happened: The FDA approved Roche's Enspryng (satralizumab) for thyroid eye disease, the only at-home subcutaneous treatment option currently available for the condition.
Key numbers: SatraGO-2 showed a 52.9% proptosis response rate versus 23.4% for placebo, and a 60.7% reduction in double vision versus 25.8%. The disease affects roughly 155 per 100,000 individuals. RHHBY shares were up 0.93% at $57.31.
Why it matters: The approval gives Roche a differentiated at-home option in thyroid eye disease, where Viridian's elegrobart posted positive Phase 3 results in May.