FDA Grants Breakthrough Therapy Designation to Incyte's INCA033989 for Essential Thrombocythemia

Reuters12-07

FDA Grants Breakthrough Therapy Designation to Incyte's INCA033989 for Essential Thrombocythemia

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Incyte Corporation's INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody. This designation is for the treatment of essential thrombocythemia $(ET)$ patients with a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy. The decision was supported by early Phase 1 data showing that INCA033989 was well-tolerated and achieved rapid, durable normalization of platelet counts. Incyte plans to initiate a Phase 3 program evaluating INCA033989 in ET patients with all types of CALR mutations in mid-2026, pending regulatory alignment. Updated safety and efficacy data will be presented at the 2025 ASH Annual Meeting.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Incyte Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20251207536613) on December 07, 2025, and is solely responsible for the information contained therein.

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