INCA033989 SubQ / Incyte, Halozyme - LARVOL DELTA

A Phase 1 study evaluating INCA033989 as a subcutaneous (SC) administration in mutCALR positive patients was initiated in the second quarter of 2026. (Businesswire)

Trial status • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm

Halozyme Announces Global Collaboration and License Agreement with Incyte to Support the Development of Subcutaneous Formulations of INCA033989 Using its ENHANZE Technology (PRNewswire) - "Under the terms of the agreement, Halozyme will receive an upfront payment from Incyte and is eligible to receive additional payments upon achievement of agreed upon milestones. In addition, Halozyme is eligible to receive royalties on net sales of commercialized medicines using ENHANZE. Under the collaboration, Incyte also has the option to nominate up to two additional targets for use with ENHANZE."

CALR • Licensing / partnership • Myeloproliferative Neoplasm

Key Business Updates (Incyte Press Release) - "The Company is on track to initiate a Phase 3 registrational study evaluating INCA033989 in mutCALR positive patients with essential thrombocythemia (ET) who are resistant or intolerant to at least one prior cytoreductive therapy in mid-2026 following a successful end-of-phase meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026; Updated data from the ongoing Phase 1 trial in second-line ET and myelofibrosis (MF) patients are anticipated in mid-2026. Data from the cohort evaluating INCA033989 and INCA033989 in combination with ruxolitinib in treatment naïve MF patients are anticipated in the second half of 2026....The Company plans to initiate a Phase 1 study evaluating INCA033989 as a SC administration in mutCALR positive patients mid-year 2026."

CALR • New P1 trial • New P3 trial • P1 data • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm