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Full analysis, sources & comparables →AL amyloidosis has an estimated US incidence of 8.9-10 cases per million per year (approximately 3,000-4,500 new cases annually) and a prevalence of roughly…
CAEL-101 demonstrated favorable safety and tolerability and provided supportive evidence of organ response when added to standard of care plasma cell-directed…
Efficacy and Safety of Anselamimab in Immunoglobulin Light Chain Amyloidosis: Results From the Randomized CARES Trials. The program did not meet its primary…
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AstraZeneca's Alexion exercised its option to acquire all remaining equity in Caelum Biosciences (Oct 2021) for $150M upfront plus up to $350M in regulatory/commercial milestones (~$500M total), building on Alexion's January 2019 stake-plus-option. The lead asset, CAEL-101 (now anselamimab), is a potentially first-in-class fibril-reactive monoclonal antibody designed to clear amyloid deposits in AL amyloidosis. The thesis hinged on the pivotal CARES Phase III programme (CARES-1/-2, >400 patients in Mayo Stage IIIa/IIIb cardiac AL). CARES MISSED its primary endpoint in the overall population (March 2025). Updated full results presented at ASCO 2026 (29 May 2026) and published in JCO showed a prespecified kappa light-chain subgroup (n=72) with nominally significant, clinically meaningful benefit: all-cause mortality reduced 62% (HR 0.38) and cardiovascular hospitalizations reduced 71% (IRR 0.29), with mortality reductions of 75% in Mayo IIIa and 48% in Mayo IIIb. AstraZeneca has repositioned the program to the kappa subset and is pursuing regulatory submissions for kappa AL amyloidosis in the EU and Japan; a US FDA submission is not currently listed in its pipeline. The broad-population failure puts most of the $350M contingent milestones at risk, while the narrowed kappa path preserves partial first-in-class optionality.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| AstraZeneca PLC / Caelum Biosciences (this deal) | 2021 | $500M | — |
| AstraZeneca PLC / Daiichi Sankyo Company, Limited | 2019 | $6.9B | 100 |
| AstraZeneca PLC / KuDOS Pharmaceuticals Limited | 2005 | $210M | 98 |
| AstraZeneca PLC / Alexion Pharmaceuticals Inc. | 2020 | $39.0B | 86 |
| AstraZeneca PLC / Acerta Pharma | 2015 | $4.0B | 86 |
| AstraZeneca PLC / Amgen Inc. | 2020 | $2.3B | 84 |
| AstraZeneca PLC / MedImmune Inc. | 2007 | $15.6B | 82 |
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