GLOBAL RESEARCH ARCHIVE
Abivax (AO) | Buy | Management remains highly confident ahead of end-June catalyst
Research evidence excerpt
Abivax (AO) | Buy | Management remains highly confident ahead of end-June catalyst
dollar UC franchise and discussed a potential USD4-6bn peak sales opportunity in UC in the US alone.
Management reiterated that no financing transaction is expected in the coming weeks and highlighted that financing and
partnering discussions cannot be conducted simultaneously under French market regulations. With discussions with potential
pharmaceutical partners expected over the coming weeks, we continue to believe that strategic optionality remains intact and
may ultimately be reinforced by the strength of the Phase III data.
End-June safety update now the key catalyst
One of the most important takeaways from the call relates to the upcoming Part 2 safety dataset, expected by the end of June.
Originally expected in mid-July, the company decided to accelerate the release of Part 2 data following the recent market
reaction.
The update will include approximately 600 additional patients, including c.400 exposed to 50mg, significantly expanding the
safety database. Management believes these data should help provide a more definitive assessment of the apparent malignancy
imbalance observed in the maintenance study.
Beyond the topline safety data, the company also intends to provide additional context around individual cases, exposure-
adjusted incidence rates, competitive benchmarks, regulatory considerations and feedback from former FDA experts currently
advising the company.
Management pushes back against cancer concerns
The company repeatedly emphasised that it does not view the current observations as a true treatment-related cancer signal. In
particular, management highlighted that one of the three reported non-NMSC malignancies, colonic dysplasia, is not considered
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