"With positive top-line results having been reported for IMerge Phase 3, we now have a charted path toward several potentially significant regulatory and commercial catalysts, which we expect will further enhance the value of imetelstat. As the first step, we are focused on completing and submitting a U.S. New Drug Application (NDA) and a European Marketing Authorization Application for imetelstat in lower risk MDS in 2023," said John A. Scarlett, CEO. "Also in 2023, we will be implementing many of the long-lead time operational items needed to prepare for potential commercial launch of imetelstat in lower risk MDS in the U.S., such as establishing key sales-related systems, engaging a third-party logistics provider, manufacturing sufficient commercial supply of drug for launch and beyond, and hiring deeply experienced commercial talent. On top of our efforts to advance imetelstat toward commercialization in lower risk MDS, we continue to make progress on recruiting and enrolling patients into IMpactMF, our imetelstat Phase 3 trial in relapsed/refractory MF. Reaching a sufficient number of events to enable an interim analysis readout from this trial in 2024 depends on sufficient enrollment, as well as the rate at which actual death events occur during the course of the trial. We expect to have a better view on timing of the interim analysis in the second half of this year. As a result of robust and compelling data from IMerge Phase 3, we believe there will be renewed attention on telomerase inhibition as an oncology approach. Thus, we have positioned our exploratory programs in other hematologic malignancies to provide data over the next several years to add strategic value to the imetelstat franchise."
Published first on TheFly
