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PDUFAApproval decision

WELIREG/Belzutifan (MK-6482) + LENVIMA/Lenvatinib (E7080) (HIF-2α Combo)

Advanced Clear Cell Renal Cell Carcinoma After PD-1/PD-L1 Therapy

MRKMerck & Co
Expected catalystOctober 4, 2026Company guidance: Oct 4, 2026

Catalyst overview

Event details

Drug or asset
WELIREG/Belzutifan (MK-6482) + LENVIMA/Lenvatinib (E7080) (HIF-2α Combo)
Development stage
PDUFA
Event type
Approval decision
Indication
Advanced Clear Cell Renal Cell Carcinoma After PD-1/PD-L1 Therapy
Research signalsHigh management interest

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for WELIREG/Belzutifan (MK-6482) + LENVIMA/Lenvatinib (E7080) (HIF-2α Combo) in Advanced Clear Cell Renal Cell Carcinoma After PD-1/PD-L1 Therapy. The expected timing is based on the latest available company guidance and may change.

Development notes

02/28/26:- LITESPARK-011 Ph3 interim PFS positive; FDA accepted sNDAs; PDUFA October 4, 2026.

Verification

Primary source

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

Open source

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Company

Merck & Co

MRK · NYSE
Industry
Biotechnology
Pipeline assets
96
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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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