Reports of Eli Lilly meeting with French Treasury officials sparked concern about regulatory hurdles. However, analysts believe France's foreign investment screening is routine and unlikely to block a deal for Abivax, pointing to government support for prior biomedical acquisitions like AstraZeneca's purchase of Amolyt.
Abivax's drug has a novel, not fully understood mechanism (miR-124). However, analysts believe strong clinical data across thousands of patients can trump this ambiguity for doctors and regulators, citing historical precedents like Revlimid for drugs that gained approval despite unclear biological pathways.
Analysts and Abivax's CEO believe the upcoming maintenance trial for its drug Obafazimod has a very high probability of success. This confidence is based on the historical rarity of drugs succeeding in the initial 'induction' phase but then failing in the longer 'maintenance' phase for ulcerative colitis.
A theoretical cardiac safety risk for Abivax's drug was first highlighted by competitor AbbVie at an investor conference. Analysts believe this risk is unlikely based on existing clinical data, suggesting such concerns can be a competitive tactic to cast doubt on a rival's asset rather than a significant clinical signal.
Analysts largely overlooked Abivax before its major data success because it was a European company with a recent US listing, its drug was repurposed from an initial indication in HIV, and investor attention in the IBD space was focused on other high-profile mechanisms like TL1A and S1Ps.
Despite a pivotal data readout pending, an acquisition of Abivax could happen beforehand. Historical deals like Merck's acquisition of Prometheus and Pfizer's of Arena show that large pharma companies are willing to 'roll the dice' and pay a premium for pre-data assets when their conviction in the science is high.
Crohn's disease is a higher bar for drug approval than ulcerative colitis, often due to fibrotic strictures. Abivax has presented preclinical data suggesting its drug has anti-fibrotic properties. This is a key differentiator, as therapies that fail in Crohn's often lack this effect, providing a mechanistic rationale for potential success.