FDA Approves Jemperli in Rectal Cancer Months Ahead of PDUFA Date
ANAB has more than doubled off its 52-week low of $20.177.
Summary
The FDA approved Jemperli (dostarlimab) as the first and only immunotherapy for adults with stage II/III MSI-H/dMMR locally advanced rectal cancer, well ahead of the February 2027 PDUFA date thanks to Priority Review and a National Priority Voucher. AnaptysBio discovered the drug and holds a royalty interest under its 2014 license to Tesaro, now part of GSK — it does not commercialize the product itself, so the value here is the royalty stream, not a product launch. The approval rests on AZUR-1, which showed 68% (98/144) of evaluable patients achieving a 12-month clinical complete response by investigator assessment, with 47% (54/116) by independent central review as data mature. This follows the September 28 report that AZUR-1 met its primary endpoint; the approval converts that clinical readout into a commercial label and a durable royalty base. Full AZUR-1 interim data land as a late-breaking abstract at ESMO on October 25, 2026, which will be the next hard datapoint on the independent-review response rate.
At the time of this announcement, ANAB was trading at $49.23 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.5B. The 52-week trading range was $20.18 to $72.36. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.