Akash Tiwari's questions to Alkermes Plc (ALKS) leadership • Q4 2024
Question
Amy Li, on behalf of Akash Tiwari, asked about Alkermes's confidence in ALKS 2680's ability to differentiate on safety from competitors in NT1 and what the FDA requires for Phase II dose exploration before moving to Phase III.
Answer
CEO Richard Pops declined to comment on competitor programs but highlighted the rigorous design of Alkermes's Phase II studies (80 patients, multi-week, parallel design) to fully characterize the drug's profile. He stated the program is already differentiated by its dosing flexibility and that the orexin class has generally shown profound efficacy with mild, transient side effects.