The company now expects to announce topline data by the end of January 2022. Assuming positive results, the company intends to file a New Drug Application with the US Food and Drug Administration in 2Q22.
Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1 / ALK2 inhibitor for the potential treatment of myelofibrosis.
Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.
Momelotinib is currently under investigation in the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study for symptomatic and anemic myelofibrosis patients.
The study enrolled 195 patients based on a planned 180 patients across 21 countries.
Topline data are anticipated by the end of January 2022, and assuming positive results, the company intends to file an NDA with the FDA in 2Q22.
Sierra Oncology is a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer.
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