Evaluation of Milvexian Following Recent Acute Coronary Syndrome

“Today's news confirms the complexity of treating ACS and the need to further advance knowledge of the disease. Given that milvexian did not lead to any new safety concerns in this trial, the inhibition of factor XIa continues to be a promising mechanism within the broader thrombotic treatment space that may lead to advances beyond the standard of care for thrombotic diseases.”

“Together with Johnson & Johnson, we remain confident in the potential of milvexian to redefine anticoagulant therapy and provide patients and clinicians a new therapeutic option for reducing thrombosis risks without significantly increasing potential bleeding risks. Our belief in both the SSP and AF studies remains high and is rooted in robust data from large Phase 2 clinical studies conducted in relevant patient populations and on different background treatment. The Librexia SSP and AF studies are distinct from Librexia ACS in several aspects, including patient populations, endpoints, type and duration of background therapy and disease pathology.”

“We view the AF indication as being distinct, with the largest market opportunity, and that trial is evaluating a 100mg BID dose, so it may have less read-through from today's setback. Our model currently includes contribution from milvexian in the secondary stroke prevention and nonvalvular atrial fibrillation settings only, and therefore today's update does not materially change our estimates.”