Merck Licenses SciBrunch Drug, Expands Welireg Kidney Indication, and Withdraws Lung Cancer Filing

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[MRK](/stocks/MRK) licensed SciBrunch's preclinical oral KRAS G12D drug SPR2015 for $400 million upfront and up to $1.73 billion in milestones, taking a $400 million third-quarter charge. The FDA approved Welireg with Lenvima for a third indication in advanced kidney cancer, while Merck and Daiichi Sankyo withdrew an accelerated-approval filing for ifinatamab deruxtecan in lung cancer but continue the Phase III program.

Merck (MRK) signed a global licensing deal with China's SciBrunch worth up to $2.13 billion. Merck pays $400 million upfront and up to $1.73 billion in milestones for SPR2015, an oral drug targeting KRAS G12D, a mutation common in pancreatic, colorectal and lung cancers. The asset is early: SPR2015 is in preclinical development and has not yet entered human testing. The deal will produce a pre-tax charge of $400 million, or about 13 cents per share, in Merck's third-quarter 2026 results, and it is part of Merck's push to broaden its cancer pipeline ahead of Keytruda patent expirations later this decade.

On the regulatory front, the FDA expanded the label of Merck's oral drug Welireg (belzutifan) to a third indication: in combination with Eisai's Lenvima for adults with advanced clear cell renal cell carcinoma following a PD-1/PD-L1 inhibitor . The approval rests on the Phase III LITESPARK-011 study, which met its progression-free survival endpoint with a 26% reduction in the risk of progression or death but did not meet its overall survival endpoint. Welireg generated $470 million in sales in the first half of 2026, up 57% year over year.

The setback of the day came in lung cancer. Merck and partner Daiichi Sankyo voluntarily withdrew their FDA filing seeking accelerated approval for ifinatamab deruxtecan in extensive-stage small cell lung cancer after the FDA indicated that available data, including the Phase II IDeate-Lung01 study, did not satisfy accelerated-approval requirements . The program continues: enrollment in the Phase III IDeate-Lung02 study is nearing completion, and those data could support a future filing. It is the second candidate under the companies' 2023 antibody-drug conjugate agreement to have a filing withdrawn.

What to watch: IDeate-Lung02 results as the path back to a lung cancer filing, Welireg's uptake in the new kidney cancer setting given the missed survival endpoint, and when SPR2015 enters the clinic. Merck shares are up 41% year to date against 13% for the industry.

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