Seeking Alpha

Incyte’s First-in-Class mutCALR-Targeted Monoclonal Antibody, INCA033989, Granted Breakthrough Therapy Designation by U.S. FDA

The Company plans to initiate a Phase 3 program evaluating INCA033989 in essential thrombocythemia (ET) patients with all types of CALR mutations in mid-2026, following alignment with regulators ...
Seeking Alpha

QIAGEN and Incyte Announce Precision Medicine Collaboration to Develop Companion Diagnostics for Patients With Mutant CALR-expressing Myeloproliferative Neoplasms (MPNs)

QIAGEN to create a multimodal panel using next-generation sequencing (NGS) technology for detecting clinically relevant gene alterations in hematological malignancies Companion diagnostic to identify ...
Nasdaq

Positive Late-Breaking Data for Incyte’s First-in-Class mutCALR-targeted therapy INCA033989 in Essential Thrombocythemia Presented at EHA2025

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced the first clinical data from two studies evaluating the safety, tolerability and efficacy of INCA033989, a novel, first in ...
Nasdaq

Incyte's Rare Blood Cancer Therapy Gets FDA's Breakthrough Status

Incyte INCY announced that the FDA has granted the Breakthrough Therapy designation to its investigational, first-in-class, mutCALR-targeted monoclonal antibody, INCA033989, to treat patients with ...
Monthly Prescribing Reference

FDA Grants Breakthrough Status to Novel Antibody for Essential Thrombocythemia

Preliminary findings from 51 evaluable ET patients showed treatment with INCA033989 monotherapy demonstrated rapid and durable normalization of platelet counts. The Food and Drug Administration (FDA) ...
The American Journal of Managed Care

Painting a More Distinct Clinical Picture of MPN-U

MPN-U patients exhibit lower platelet counts and higher venous thrombosis rates compared to ET, with thrombosis often occurring at atypical sites. Genetic analysis shows JAK2 mutations are more common ...
Morningstar

Incyte’s First-in-Class mutCALR-Targeted Monoclonal Antibody, INCA033989, Granted Breakthrough Therapy Designation by U.S. FDA

CALR mutations are the second most common oncogenic driver mutation and are observed in 25% of patients with ET. A 52-bp deletion, also known as a Type 1 mutation, occurs in 55% of patients with a ...