AnaptysBio shares rose on October 19, 2026, as the US Food and Drug Administration granted accelerated approval to GSK’s Jemperli for certain adults with locally advanced rectal cancer. The decision expands the partnered drug’s approved use and came four months ahead of the FDA’s target date.
Key Takeaways
- The approval covers adults with stage II or III rectal cancer that is MSI-H or dMMR.
- AnaptysBio’s connection to Jemperli stems from a licensing agreement with TESARO, which GSK later acquired.
- The regulatory decision broadens the drug’s approved use but does not establish a specific revenue gain for AnaptysBio.
Table of Contents
- AnaptysBio shares advance alongside the approval
- Trial results define the evidence behind the new use
- Conclusion
AnaptysBio shares advance alongside the approval
The FDA’s accelerated approval decision covers Jemperli, also known as dostarlimab, for adults with stage II or III locally advanced rectal cancer that is microsatellite instability-high, or MSI-H, or mismatch repair deficient, or dMMR. Eligibility must be determined by an FDA-authorized test for solid tumors.
GSK obtained rights to Jemperli through its $5.1 billion acquisition of TESARO, which had licensed the drug from AnaptysBio. The expanded indication gives GSK another approved setting in which to market the anti-PD-1 therapy.
The share-price increase accompanied the regulatory announcement, but no percentage gain or closing price was provided. The approval also does not, by itself, quantify additional licensing payments or revenue for AnaptysBio.
| Item | Details |
|---|---|
| Recommended dose | 500 mg intravenously every three weeks |
| Treatment duration | Up to nine cycles, stopping earlier for disease progression or unacceptable toxicity |
| Response assessment | Endoscopy, rectal MRI, and CT scans of the chest, abdomen and pelvis |
| Safety warnings | Include immune-mediated adverse reactions, infusion-related reactions and embryo-fetal toxicity |
Trial results define the evidence behind the new use
The FDA evaluated efficacy in AZUR-1, a multicenter, single-arm, open-label trial involving 154 previously untreated patients. The primary efficacy measure was a clinical complete response sustained for 12 months, assessed through independent central review.
Among 116 patients evaluable by independent review, the sustained complete-response rate was 47%, while the objective response rate was 79%. These are different measures: an objective response does not necessarily mean a complete response sustained for a year.
Across all 154 treated patients, 110 received dostarlimab alone without additional treatment or disease progression. Other patients underwent surgery, received additional systemic therapy or radiation, or had other outcomes. The findings therefore should not be read as showing that every patient avoided further treatment.
The FDA also reviewed a separate, investigator-led study of 50 patients. Its 12-month sustained clinical complete-response rate was 93%; those results came from a separate study population and should not be combined with AZUR-1’s figures.
Conclusion
The US decision expands Jemperli’s approved treatment population earlier than scheduled. International regulatory reviews remain ongoing, making those decisions a further development to watch; the FDA approval does not establish their outcomes.
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