Incyte’s First-in-Class mutCALR-Targeted Monoclonal Antibody, INCA033989, Granted Breakthrough Therapy Designation by U.S. FDA
Incyte Corporation (INCY)
Last incyte corporation earnings: 2/13 07:00 am
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Source: Business Wire
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 regulatorsUpdated safety and efficacy data for INCA033989 in ET, and new data in myelofibrosis (MF), will be presented at the upcoming 2025 ASH Annual Meeting WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody, for the treatment of patients with essential thrombocythemia (ET) harboring a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy.ET is a chronic myeloproliferative neoplasm (MPN) characterized by persistently elevated platelet counts due to abnormal blood cell production in the bone marrow. CALR mutations are the second most common oncogenic driver muta
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INCY
Earnings
- 10/28/25 - Beat
INCY
Sec Filings
- 12/22/25 - Form 4
- 12/19/25 - Form 144
- 12/19/25 - Form 144
- INCY's page on the SEC website