Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
Enspryng (satralizumab) is a Roche Holding AG program in thyroid eye disease (TED). Its PDUFA date is Oct 15, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: Thyroid eye disease (TED). Sponsor: Roche Holding AG (RHHBY). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is Enspryng (satralizumab)'s next FDA decision or readout?
Enspryng (satralizumab)'s PDUFA date is Oct 15, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at Enspryng (satralizumab)'s most recent FDA decision?
No FDA decision for Enspryng (satralizumab) is in our archive yet.
What is Enspryng (satralizumab) used for?
In our records Enspryng (satralizumab) is under review or in development for Thyroid eye disease (TED).
Who makes Enspryng (satralizumab)?
Roche Holding AG (RHHBY).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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