AnaptysBio reports Jemperli royalties up 34% as FDA decision looms
AnaptysBio has reported collaboration revenue of $53 million for the six months ended 30 June 2026, driven by a 34% year-on-year increase in royalties from Jemperli, the anti-PD-1 antibody dostarlimab marketed by GSK. Global net sales of the drug reached $644 million (approximately £480 million) across the same period, with $331 million attributed to the second quarter alone, representing 26% growth on the prior-year quarter.
The San Diego-based company operates primarily as a royalty management vehicle following its April 2026 separation from First Tracks Biotherapeutics. AnaptysBio holds financial collaboration agreements with GSK on Jemperli and with Vanda on imsidolimab (Quimilza), a biologic targeting the interleukin-36 receptor in rare inflammatory skin disease. The company's chief executive, Daniel Faga, said it expects further ex-US sales acceleration for Jemperli and anticipates FDA approval of both products within the next six months.
Regulatory pipeline
The most closely watched near-term catalyst is the FDA's PDUFA action date of February 2027 for Jemperli as a monotherapy in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer. This follows positive interim results from the pivotal AZUR-1 Phase 2 trial, announced in July 2026, in which the drug met its primary objective by demonstrating a clinical complete response rate sustained for at least 12 months with no detectable cancer. AnaptysBio holds an FDA Commissioner's National Priority Voucher received in November 2025, which could bring forward the review timetable ahead of the February date.
GSK is scheduled to present the first AZUR-1 results as a late-breaking abstract at the ESMO Congress in Madrid on 25 October 2026. Two further trials are progressing: AZUR-2, a Phase 3 study of dostarlimab in resectable dMMR/MSI-H colon cancer with data expected in 2028, and JADE, a Phase 3 in locally advanced head and neck squamous cell carcinoma with a similar data readout window. A decision on Quimilza in generalised pustular psoriasis carries a separate PDUFA date of 12 December 2026.
Litigation and financial position
AnaptysBio is pursuing litigation against GSK and its Tesaro subsidiary in the Delaware Chancery Court, seeking reversion of Jemperli rights as a remedy. The trial concluded in July 2026; a post-trial hearing is scheduled for 20 October 2026, with a judgement anticipated in Q4 2026 or Q1 2027. The outcome carries material consequences: reversion of rights would fundamentally alter AnaptysBio's commercial profile and its royalty obligations to Sagard, which had accrued approximately $301 million through Q2 2026 against a total non-recourse debt monetisation arrangement that the company expects to pay down by the second half of 2027.
The wider PD-1/PD-L1 checkpoint inhibitor market remains intensely competitive, with Merck's pembrolizumab (Keytruda) and Bristol Myers Squibb's nivolumab (Opdivo) holding entrenched positions across multiple indications. Dostarlimab's focus on mismatch-repair-deficient tumour types, where response rates to checkpoint blockade are particularly strong, represents a defensible positioning strategy in indications where the biomarker-selected population can support differentiated labelling. The AZUR-1 data in rectal cancer, if confirmed in the full dataset at ESMO, could consolidate that positioning meaningfully.
Net income from continuing operations was $177 million for the second quarter, largely reflecting a $181 million income tax benefit from the release of a valuation allowance on deferred tax assets following the separation. Cash and investments stood at $164 million as of 30 June 2026.