RHHBY PDUFA Date: Enspryng Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Oct 15, 2026 · Roche Holding AG · Thyroid eye disease (TED)
Key facts FDA PDUFA target date 2026-10-15
Drug / candidate Enspryng (satralizumab)
Indication Thyroid eye disease (TED)
Company Roche Holding AG
Market-cap tier Large
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → All October 2026 PDUFA dates → 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).
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