Athena Chin

Athena Chin inquired about the status of alternative titration schedules for ulixacaltamide, whether additional studies are ongoing, and how prescribers will be educated. She also asked about capital allocation for commercial preparation between ulixacaltamide and relutrigine.

Answer

President and CEO Marcio Souza explained that a proposed label including an alternative titration schedule (staying longer at 20mg) was submitted to the FDA, with no pre-approval studies required. CFO Tim Kelly stated that ulixacaltamide would receive more capital allocation due to its broader market, while relutrigine's initial focus on SCN2A/SCN8A would involve a more targeted effort.

Athena Chin asked about the status of alternative titration schedules for ulixacaltamide, whether additional studies are ongoing, and how prescribers will be educated if these schedules are not included in the label. She also inquired about the capital allocation for commercial preparation between relutrigine and ulixacaltamide.

Answer

CEO Marcio Souza explained that Praxis proposed alternative titration schedules to the FDA, but the final label will depend on the agency's view, noting no pre-approval studies were requested. He emphasized that tolerability issues are not safety concerns and resolve quickly. CFO Tim Kelly stated that ulixacaltamide, serving a broader market, would likely receive more capital allocation for disease awareness and inventory build, while relutrigine's focused initial market would involve strategic groundwork for future indication expansion.

Athena Chin from TD Cowen asked if Compass is pursuing the commissioner's national priority voucher and what their understanding is of the eligibility criteria.

Answer

CEO Kabir Nath confirmed that Compass has submitted an application for the voucher. He explained that they believe they clearly meet three of the five criteria: significant need, public health crisis, and innovative treatment. He also noted their readiness to submit filing package elements, another requirement for the program.