RHHBY PDUFA Date: Enspryng

Name: Enspryng FDA decision
Start: 2027-01-10
End: 2027-01-10

Page updated October 15, 2026·next FDA decision on the calendar ·Data as of Oct 15, 2026 10:03 PM ET

FDA decision (PDUFA) target Jan 10, 2027 · Roche Holding AG · Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)

Also under FDA review from Roche Holding AG, as a separate application: Enspryng, Oct 15, 2026. One application, one page; this page is the METEOROID application with the Jan 10, 2027 goal date.

Key facts

FDA PDUFA target date2027-01-10

Drug / candidateEnspryng (satralizumab)

IndicationMyelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)

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 2027-01-10 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 Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).