Incyte Corporation (NASDAQ:INCY) Q1 2024 Earnings Call Transcript April 30, 2024 Incyte Corporation misses on earnings expectations. Reported EPS is $0.746 EPS, expectations were $0.88. INCY isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here). Operator: Hello and welcome to Incyte First […]
Five years after Gilead Sciences Inc. gave up on momelotinib in the wake of two phase III failures in myelofibrosis, the JAK1/2 and ACVR1 inhibitor has found its way to the market in the hands of GSK plc. Branded Ojjaara, the drug gained U.S. FDA approval for use in intermediate- or high-risk myelofibrosis patients with anemia regardless of prior administration with JAK inhibitors such as Jakafi (ruxolitinib, Incyte Corp.). The approval came a day before the Sept. 16 PDUFA date, which had been extended by three months in June to allow the agency to review recently submitted data. A rare blood cancer characterized by dysregulated JAK-signal transducer and resulting in splenomegaly and progressive anemia, myelofibrosis affects roughly 25,000 people in the U.S.
Enrollment to the phase 3 MANIFEST-2 trial, which is examining the safety and efficacy of pelabresib plus ruxolitinib vs ruxolitinib alone in patients with JAK inhibitor–naïve myelofibrosis, has completed and topline findings are anticipated by the end of 2023.