Pharma BD Deal Intelligence

Janssen (Cilag GmbH International, J&J) / argenx SE

2018 · Licensing/Option · $1.8B · Terminated

Janssen's $300M upfront bet on argenx's cusatuzumab looked like strong platform validation in 2018, but the collaboration collapsed in June 2021 when Janssen discontinued it as venetoclax+azacitidine reshaped the AML standard of care, sending rights back to argenx, which spun the asset into OncoVerity in 2022.

Outcome grade pending — assessed 5 years post-close.

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The coverage arc

Dec 04, 2018 PharmaTimes Bullish

PharmaTimes covered Janssen's $300M upfront plus $200M JJDC equity stake at EUR 100.02/share, characterizing the structure as a strong validation of argenx's…

Jun 07, 2021 BioSpace Neutral

BioSpace noted argenx regained worldwide rights to cusatuzumab after Janssen termination, with argenx evaluating partnering or in-house development paths…

Jun 07, 2021 FierceBiotech Bearish

FierceBiotech reported J&J culled the $1.6B argenx collaboration in June 2021, citing the 'evolving standard of care' in AML—a tacit reference to…

Source summaries from our enrichment pipeline; follow links for originals.

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argenx and Janssen (Cilag) entered exclusive global collaboration and license for cusatuzumab (ARGX-110), an anti-CD70 antibody, in December 2018. Janssen paid $300M upfront, JJDC bought $200M in newly issued argenx shares (4.68% stake at EUR 100.02/share), with up to $1.3B in development, regulatory and sales milestones plus tiered double-digit royalties ex-US and 50/50 US co-promotion economics. Lead indication AML/MDS in elderly patients unfit for chemotherapy. The collaboration was terminated in June 2021 when Cilag/Janssen discontinued the agreement following review of all cusatuzumab data and the evolving AML standard of care (venetoclax+azacitidine), returning worldwide rights to argenx. Rather than developing cusatuzumab in-house, argenx co-created OncoVerity, Inc. in 2022 with the University of Colorado Anschutz Medical Campus and UCHealth as an asset-centric spin-off, then granted OncoVerity an exclusive license to cusatuzumab in 2023 and provided funding (with additional participation in a 2024 financing round). As of 2024-2025 OncoVerity is the program sponsor: the Phase 2 OV-AML-1231 trial (NCT06384261) of cusatuzumab plus venetoclax and azacitidine versus venetoclax+azacitidine in newly diagnosed AML unfit for intensive therapy began July 2024 (active, not recruiting; estimated primary completion January 2027).

Key facts

Disease & market context

Acute Myeloid Leukemia (AML)

22K US cases/yr

Disease Overview

Acute myeloid leukemia is an aggressive hematologic malignancy of myeloid progenitor cells, with a median diagnosis age of 68 and rapidly fatal course if untreated. Older and unfit patients—the majority of incident cases—face dismal outcomes, with 5-year survival of just 5% in those over 70. Standard induction chemotherapy ('7+3') is intolerable for many elderly patients, leaving a major unmet need for effective, lower-intensity regimens.

Competitive Landscape

At deal signing in December 2018, the unfit-AML standard of care was hypomethylating-agent monotherapy (azacitidine/Vidaza or decitabine), with median OS under 10 months. The competitive landscape was about to shift dramatically: AbbVie/Genentech's Venclexta (venetoclax, BCL-2 inhibitor) plus azacitidine received FDA accelerated approval November 2018 and full approval in October 2020 based on VIALE-A showing 14.7-month median OS, reshaping the unfit-AML market and effectively setting a new bar for any new entrant. Cusatuzumab (anti-CD70) was positioned as an add-on to azacitidine targeting leukemic stem cells, with Phase 1 data showing CR in 50% of evaluable patients. Other competitive assets included Astellas's Xospata (gilteritinib, FLT3) approved 2018, Daiichi Sankyo/Servier's Tibsovo (ivosidenib, IDH1) and Idhifa (enasidenib, IDH2), and BMS/Celgene's Onureg (oral azacitidine maintenance). The deal mattered because Janssen was making a $300M upfront bet on a novel mechanism (anti-CD70 leukemic stem-cell targeting) at the moment venetoclax was rewriting the unfit-AML treatment paradigm. Janssen terminated in June 2021 citing 'evolving standard of care'—a tacit admission venetoclax+aza had moved the goalposts.

Deal timeline

Related deals — scored

DealYearValueOutcome
Janssen (Cilag GmbH International, J&J) / argenx SE (this deal)2018$1.8B
Amgen Inc. / Micromet Inc.2012$1.2B88
Servier / Shire plc (Oncology Business)2018$2.4B88
AstraZeneca PLC / Alexion Pharmaceuticals Inc.2020$39.0B86
Swedish Orphan Biovitrum AB / Biovitrum2001$493M84
Otsuka Pharmaceutical Co. Ltd. / Astex Pharmaceuticals2013$886M79
AbbVie Inc. / Pharmacyclics Inc.2015$21.0B79

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