Australian biotech CSL Limited (OTCQX:CSLLY) fell ~4% on Monday, marking its biggest intraday loss in more than four months after its Phase 3 AEGIS-II trial, one of its key clinical programs, failed.
The global trial was designed to evaluate serum protein CSL112 against a placebo to reduce the risk of major adverse cardiovascular events such as stroke in patients after a heart attack (acute myocardial infarction).
AEGIS-II didn’t meet the main efficacy goal of MACE reduction at 90 days, CSL Limited (OTCQX:CMXHF) said, adding that there were no safety or tolerability issues. In the wake of the setback, the company has no plans for near-term regulatory submissions.
“AEGIS-II is the most ambitious study in our company’s history, and we are proud of the quality of the study we delivered and the enhanced capabilities we developed to do so,” CSL’s (OTCQX:CSLLY) R&D head, Bill Mezzanotte, remarked.