INCA033989 Clinical Trial Results and Safety - INCA033989 demonstrated a favorable safety profile in ET patients, with only 1 out of 49 patients discontinuing therapy due to treatment-emergent adverse events [101, 135] - INCA033989 led to rapid and sustained normalization of platelet counts in previously treated ET patients [105, 135] - Hematologic responses were achieved early and sustained, with 86% of patients receiving ≥400 mg achieving a response [113, 115] - A reduction in peripheral blood mutCALR VAF was observed in 89% (34/38) of evaluable patients, correlating with hematologic responses [119, 120, 135] - Biomarker analysis supports a reduction in mutCALR stem/progenitor cells and megakaryocytes in patients achieving a hematologic response [121, 127, 135] INCA033989 Mechanism and Preclinical Data - INCA033989 is a high-affinity mutant CALR selective monoclonal antibody that selectively inhibits constitutive JAK/STAT signaling induced by mutCALR [94] - INCA033989 directly inhibits mutCALR+ CD34+ HSPCs and megakaryocytes, without affecting non-mutated, healthy cells [94] - In a mutCALR conditional knock-in mouse model of established MPN, INCA033989 treatment led to platelet normalization, reversal of anemia, and elimination of megakaryocyte hyperplasia in the bone marrow [90, 94] Essential Thrombocythemia (ET) and Unmet Needs - CALR mutations account for 25% of Essential Thrombocythemia cases [19] - Current ET treatments aim to reduce disease-associated risks but do not impact the natural history [26] - There is an unmet need for disease-modifying therapies in ET [25, 43] Future Development Plans - A registrational trial in ET is planned to be initiated by early 2026 [137]

Incyte (INCY) Update / Briefing June 15, 2025 06:00 AM ET Speaker0 UNIDENTIFIED in person here in the room. And a big thank you to all of you and specifically to our presenters today for the time and the energy you are putting behind this project. So the data we'll be speaking about September. The data that was presented today is the first clinical data presented with this product. And in fact, I was thinking of the ASH preclinical presentation that was a plenary session like two years ago, two point years ...

Summary of Incyte (INCY) FY Conference Call - June 09, 2025 Company Overview - **Company**: Incyte Corporation (INCY) - **Focus**: Oncology and other therapeutic areas with a strong emphasis on drug development and commercialization Key Points Commercial Portfolio and Revenue Growth - Incyte has expanded its commercial portfolio beyond Jakafi, with expected revenues of €650 million from ObsElura and over €400 million from oncology assets in 2025, totaling over $1 billion from products outside Jakafi this year [1][2] - Four product launches are anticipated, contributing an additional $1 billion by 2029, indicating a strong growth trajectory [2] Pipeline Developments - The company is in a pivotal year with four Phase III programs, with three readouts completed and one pending [3] - The POVO program for hidradenitis suppurativa (HS) is highlighted as significant, with positive Phase III data expected to drive future growth [3][4] Mutant KALAR Program Insights - Initial Phase I data for the mutant KALAR program shows good tolerability, with only one out of 40 patients discontinuing treatment [6][7] - The program aims to normalize platelet counts and reduce the malignant clone in patients with essential thrombocythemia (ET) [8][9] Jakafi Performance - Jakafi reported a strong Q1 with 24% year-over-year growth, driven by demand, net price adjustments, and reduced destocking [21] - The company raised its 2025 guidance to approximately 7% year-over-year growth at the midpoint, with future growth expected to be demand-driven [21][22] Opselura Sales Trajectory - Opselura is projected to generate $650 million in revenue for 2025, reflecting a 28% year-over-year growth, with contributions from both the U.S. and Europe [26] - The potential approval for pediatric atopic dermatitis (AD) is seen as a significant opportunity, targeting around 2 million children in the U.S. [28][32] POVO Commercial Strategy - Despite initial data falling short of expectations, Incyte emphasizes the positive outcomes from two Phase III trials for POVO, particularly in pain improvement for HS patients [38][39] - The company anticipates a substantial commercial opportunity with approximately 30,000 patients ready for POVO at launch [42] Pipeline Diversification - Incyte's pipeline includes a variety of therapeutic modalities, including bispecifics, traditional biologics, and small molecules, which helps mitigate risks across different therapeutic areas [46] Capital Allocation Strategy - The company prioritizes its internal pipeline and is unlikely to pursue major deals in the near term, focusing instead on early-stage technologies and near-commercial assets that can enhance revenue without significantly increasing R&D costs [54][56] Additional Insights - Compliance issues in vitiligo treatment have been addressed through educational initiatives to improve patient adherence to therapy [33][34] - The company is optimistic about the potential of its pipeline to redefine treatment approaches for various malignancies, particularly in myeloproliferative neoplasms [48][49] This summary encapsulates the key discussions and insights from Incyte's FY conference call, highlighting the company's growth strategies, pipeline developments, and market opportunities.