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Home/Stocks/RHHBY/Catalyst
PDUFAApproval decision

Enspryng/Satralizumab (IL-6 Receptor Inhibitor)

Thyroid Eye Disease

RHHBYRoche Holding
Expected catalystOctober 15, 2026Company guidance: Oct 15, 2026

Catalyst overview

Event details

Drug or asset
Enspryng/Satralizumab (IL-6 Receptor Inhibitor)
Development stage
PDUFA
Event type
Approval decision
Indication
Thyroid Eye Disease

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for Enspryng/Satralizumab (IL-6 Receptor Inhibitor) in Thyroid Eye Disease. The expected timing is based on the latest available company guidance and may change.

Development notes

06/14/26:- FDA accepted priority sBLA for TED; decision expected October 15, 2026. 07/23/26:- Priority review for thyroid eye disease was reiterated; FDA decision will occur October 15, 2026.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

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Company

Roche Holding

RHHBY · OTC Markets OTCQX
Industry
Biotechnology
Pipeline assets
61
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Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
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