AnaptysBio Reports 34% Jemperli Sales Growth, Awaits Key FDA Decision
Event summary
- Jemperli global net sales reached $644 million for the six months ended June 30, 2026, up 34% year-over-year.
- FDA assigned a PDUFA action date of February 2027 for Jemperli in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer, with potential expedited review.
- Litigation with GSK and Tesaro ongoing, with a judgement anticipated in Q4 2026 or Q1 2027.
- AnaptysBio expects to achieve over $390 million in annualized Jemperli royalties by 2029 at GSK’s peak sales guidance of $2.7 billion.
- FDA target action date for Quimilza in generalized pustular psoriasis set for December 12, 2026.
The big picture
AnaptysBio’s strong financial performance is underpinned by Jemperli’s robust commercial growth and strategic regulatory milestones. The company’s focus on managing royalty agreements and navigating litigation highlights the tension between commercial expansion and legal risks. The broader biotech sector is watching closely as AnaptysBio positions itself to capitalize on potential FDA approvals and peak sales projections.
What we're watching
- Regulatory Timing
- Whether the FDA’s expedited review process will accelerate Jemperli’s approval timeline beyond the February 2027 PDUFA date.
- Litigation Impact
- How the outcome of the litigation with GSK and Tesaro could affect AnaptysBio’s control over Jemperli’s financial collaborations.
- Commercial Expansion
- The pace at which Jemperli’s sales growth can be sustained outside the U.S., particularly in key international markets.
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