Chimerix reports Q1 EPS (25c), consensus (22c)

“Patients, caregivers and physicians are in desperate need for novel therapies that offer clinical benefit in H3 K27M-mutant diffuse glioma, and we believe that dordaviprone has the potential to be a major therapeutic advance in the treatment of this disease,” said Mike Andriole, Chief Executive Officer of Chimerix. “We remain intensely focused on completion of the ACTION study and will continue to be active and collaborative with regulators to bring dordaviprone to patients in need as soon as possible. In parallel, we are continuously evaluating options to accelerate access to dordaviprone in select markets where accelerated regulatory pathways exist as there are few treatment options for this ultra-rare disease beyond radiation therapy. As an example, our recent interaction with the Therapeutic Goods Administration in Australia is a positive initial step that is aligned to this overall strategy. Having a pivotal Phase 3 study well underway is an important consideration in global regulatory conversations that contemplate accelerated approval, and the ongoing maturation of the ACTION study enables these conversations. Furthermore, we continue to progress our second generation imipridone, ONC206, in Phase 1 dose escalation and are enthusiastic about the differentiated profile and activity seen with this molecule thus far. We expect to pursue novel development opportunities apart from dordaviprone and look forward to describing the future development path of ONC206 by the end of the year,” concluded Mr. Andriole.