RHHBY PDUFA Date: Enspryng

Name: Enspryng FDA decision
Start: 2026-10-15
End: 2026-10-15

Page updated October 10, 2026·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET

FDA decision (PDUFA) target Oct 15, 2026 · Roche Holding AG · Thyroid eye disease (TED)

The sBLA is supported by SatraGO-1 and SatraGO-2. Per Genentech, in SatraGO-2 53% of patients on Enspryng achieved a proptosis response at week 24 versus 23% on placebo, meeting statistical significance; in SatraGO-1 the figures were 49% versus 31%, which did not meet statistical significance. (Genentech, June 29, 2026)

Key facts

FDA PDUFA target date2026-10-15

Drug / candidateEnspryng (satralizumab)

IndicationThyroid eye disease (TED)

CompanyRoche Holding AG

Market-cap tierLarge

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FAQ

When is the RHHBY PDUFA date?

The FDA PDUFA target date for RHHBY (Roche Holding AG) is 2026-10-15 for Enspryng (satralizumab). Dates are company/FDA-sourced and can slip. Verify against primary filings.

What is RHHBY's drug Enspryng?

Enspryng (satralizumab) is Roche Holding AG's candidate under FDA review for Thyroid eye disease (TED).