WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced updated clinical data from two Phase 1 studies evaluating the safety, tolerability and efficacy of INCA033989, a first-in-class mutant calreticulin (mutCALR)- targeted monoclonal antibody, as a treatment for patients with mutCALR-expressing myeloproliferative neoplasms (MPNs). These data, which are featured in oral presentations at the 2025 American Society of Hematology (ASH) Annual Meeting in Orlando (Session 634, Publication #1024; S ...

Core Insights - Incyte Corporation (NASDAQ:INCY) is a biopharmaceutical company focused on proprietary therapeutics development and commercialization [1][5] - Morgan Stanley has set a price target of $92 for Incyte, indicating a potential decline from the current stock price of $96.47, reflecting a -4.63% difference [1][5] - First Trust Advisors LP has reduced its holdings in Incyte by 1.6%, selling 12,101 shares, which aligns with Morgan Stanley's cautious outlook [2][5] Investor Actions - Cetera Investment Advisers increased its stake in Incyte by 10.2%, now holding 14,644 shares valued at $887,000, indicating a positive perspective on the company [3] - Vanguard Group Inc. expanded its stake by 2.1%, owning 19,997,823 shares, reflecting differing investor sentiments regarding Incyte's potential [3] Stock Performance - The current stock price of Incyte is $96.29, marking a 6.08% decrease with a $6.24 drop, and fluctuated between $96 and $100.43 today [4] - Over the past year, Incyte's stock reached a high of $109.28 and a low of $53.56, with a market capitalization of approximately $18.9 billion and a trading volume of 814,496 shares [4]

Core Insights - Incyte (INCY) has received FDA Breakthrough Therapy designation for its investigational monoclonal antibody INCA033989, aimed at treating essential thrombocythemia (ET) patients with Type 1 CALR mutations who are resistant or intolerant to at least one cytoreductive therapy [1][6][10] Group 1: FDA Breakthrough Therapy Designation - The FDA's Breakthrough Therapy designation accelerates the development and review of drugs for serious conditions, granted when early clinical evidence indicates significant improvement over existing treatments [2] - This designation provides enhanced guidance and support from senior FDA managers [2] Group 2: Clinical Data and Efficacy - Early phase I data for INCA033989 showed it was well tolerated and resulted in rapid and sustained normalization of platelet counts, with stronger responses at higher doses [3][6] - The treatment demonstrated robust clinical benefits in CALR-mutant myelofibrosis, both as a standalone therapy and in combination with Jakafi [7][8] Group 3: Patient Population and Disease Context - Essential thrombocythemia (ET) is a chronic myeloproliferative neoplasm characterized by excessive platelet production, with CALR mutations present in about 25% of ET patients [4] - The Type 1 CALR deletion is linked to a higher risk of progression to myelofibrosis among ET patients [4] Group 4: Future Development Plans - Incyte plans to initiate a registrational phase III program for INCA033989 in mid-2026, targeting both Type 1 and non-Type 1 CALR mutation patients [10][12]

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh. ...

Core Insights - The presentation is focused on data from the company's program referred to as 989, which is significant for its implications in treating patients with essential thrombocythemia (ET) and myelofibrosis (MF) [1] Group 1: Presentation Context - The presentation was delayed due to adherence to ASH guidelines and the availability of speakers who were presenting scientific data at the meeting [1] - The session is expected to last approximately 45 minutes, during which the company will review data related to the 989 program [1] Group 2: Data Significance - Some of the data being discussed was previously presented in June at the AHA conference, indicating ongoing research and development efforts [1] - The company emphasizes the importance of the translational data and its relevance to the treatment of MF, highlighting the potential impact of their research [1]

stocks they discuss. We make no representations or warranties regarding the advisability of investing in any particular securities or utilizing any specific investment strategies. Information is subject to change without notice. For information on use of our services, please see our Terms of Use. *Real-time prices by Nasdaq Last Sale. Real-time quote and/or trade prices are not sourced from all markets. Ownership data provided by LSEG and Estimate data provided by FactSet. IBD, IBD Digital, IBD Live, IBD We ...

Incyte Update Summary Company Overview - **Company**: Incyte Corporation - **Ticker**: NasdaqGS: INCY - **Event**: Update/Briefing on December 07, 2025 Industry Focus - **Industry**: Myeloproliferative Neoplasms (MPNs) - **Key Conditions**: Essential Thrombocythemia (ET), Myelofibrosis (MF) Core Points and Arguments 1. **Significance of INCA033989**: The company believes that INCA033989 has the potential to redefine the standard of care for patients with MPNs, aiming for not just symptomatic improvement but true disease eradication [2][5][32] 2. **Clinical Data Presentation**: Data presented includes results from the 989 program, focusing on its efficacy in patients with ET and MF, with emphasis on the ability to normalize hematopoiesis [1][2][3] 3. **Breakthrough Therapy Designation**: INCA033989 received Breakthrough Therapy Designation from the FDA for patients with essential thrombocythemia, indicating the potential for accelerated approval [6] 4. **Patient Demographics**: The majority of patients in the studies had CALR mutations, which are present in approximately 35% of MF patients [4][57] 5. **Efficacy Results**: - In the monotherapy cohort, 42% achieved SVR25 and 33% achieved SVR35 at week 24 [22][59] - 93% of patients experienced symptom improvement, with 60% achieving TSS50 [24][60] - Anemia responses were observed in 56% of patients, with 40% achieving a major response [61] 6. **Safety Profile**: INCA033989 was reported to be well tolerated, with no dose-limiting toxicities and a high retention rate of 86.5% in the study [19][31][58] 7. **Future Trials**: Plans to initiate a phase three trial for second-line ET and a second-line MF study in the second half of 2026, focusing on the IV administration of INCA033989 [63][64] Additional Important Content 1. **Mutant CALR Targeting**: The therapy specifically targets mutant CALR, which is a significant driver in MPNs, and aims to reduce the burden of the disease effectively [34][56] 2. **Molecular Characterization**: The presentation included detailed molecular characterization of patients, highlighting the complexity of mutations and their implications for treatment [33][40] 3. **Patient Engagement**: There is a noted increase in CALR mutant patients seeking treatment, indicating a growing awareness and interest in targeted therapies [70] 4. **Long-term Goals**: Incyte aims to develop targeted therapies for all patients with MPNs by the end of the decade, indicating a commitment to addressing unmet medical needs [5][57] This summary encapsulates the key points from the Incyte update, focusing on the company's advancements in treating myeloproliferative neoplasms, particularly through the development of INCA033989.

Core Viewpoint - Incyte's monoclonal antibody, INCA033989, has received Breakthrough Therapy Designation from the U.S. FDA, indicating its potential to significantly improve treatment for patients with certain conditions [1] Group 1: Product Development - INCA033989 is a first-in-class mutCALR-targeted monoclonal antibody, highlighting its innovative approach in targeting specific mutations [1] - The Breakthrough Therapy Designation is a recognition by the FDA that suggests the drug may offer substantial benefits over existing therapies [1] Group 2: Regulatory Impact - The designation may expedite the development and review process for INCA033989, potentially leading to faster market access for patients [1] - This regulatory milestone reflects the company's commitment to advancing treatment options in the oncology space [1]

Core Insights - Incyte announced new clinical data from two Phase 1 studies on INCA033989, a first-in-class monoclonal antibody targeting mutant calreticulin (mutCALR) for patients with myeloproliferative neoplasms (MPNs) [1][2] - The studies evaluated INCA033989 as a monotherapy and in combination with ruxolitinib for patients with myelofibrosis (MF) who are resistant or intolerant to JAK inhibitors [1][2] - Preliminary results showed promising efficacy and safety profiles, with plans for a registrational program in 2026 [2][8] Study Results - In the monotherapy arm, 41.7% of evaluable MF patients achieved a spleen volume reduction of 25% (SVR25) and 33.3% achieved a 35% reduction (SVR35) at Week 24 [5] - Among patients not previously treated with JAK inhibitors, 71.4% achieved SVR25 and 57.1% achieved SVR35 [5] - In the combination therapy arm, 81.3% of patients experienced symptom improvement, with 33.3% achieving a 50% reduction in total symptom score (TSS50) [5] Safety and Tolerability - INCA033989 was well-tolerated, with no dose-limiting toxicities reported in both monotherapy and combination therapy arms [4][6] - The most common treatment-emergent adverse events (TEAEs) were anemia, fatigue, and thrombocytopenia, primarily Grade 1 [13] - Only two patients discontinued treatment due to TEAEs, indicating a favorable safety profile [13] Future Plans - Incyte plans to initiate a registrational program for INCA033989 in MF in 2026, building on the positive results observed [2][8] - The drug is also being evaluated for essential thrombocythemia (ET), with Breakthrough Therapy designation granted by the FDA for patients with Type 1 CALR mutations [8][11] Industry Context - Myelofibrosis (MF) is considered one of the most aggressive types of MPNs, characterized by bone marrow fibrosis and debilitating symptoms [7] - The development of targeted therapies like INCA033989 represents a significant advancement in the treatment landscape for MPNs, particularly for patients who are resistant or intolerant to existing therapies [10][11]

Group 1 - Incyte Corporation (INCY) has a market capitalization of approximately $20 billion, indicating its significant size in the market [1] - The company is not widely recognized among the general public, suggesting potential for growth and increased visibility [1] - Oakoff Investments provides a range of investment services, including a fundamentals-based portfolio and insights from institutional investors, which may benefit investors interested in INCY [1] Group 2 - The article does not provide specific financial performance metrics or projections for Incyte Corporation [2][3]