INCYTE (INCY) Company Report

Incyte’s INCA033989, an antibody targeting mutant CALR in MPNs, showed no dose-limiting toxicities or maximum tolerated dose as monotherapy and in combination with ruxolitinib, earning Breakthrough Therapy Designation in type 1 ET.
Monotherapy in relapsed/refractory MF achieved 42% SVR25 and 33% SVR35 at week 24 (best: 48% SVR25, 31% SVR35), TSS50 of 39% at week 24 (60% in JAK-naive), and 56% anemia responses.
Combination with ruxolitinib in suboptimal responders yielded best SVR25 65%, SVR35 47% (week 24: 50% SVR25, 25% SVR35) and TSS50 33% at week 24, with stable hemoglobin and minimal additional toxicity.
Translational analyses demonstrated rapid reduction of mutant CALR clone burden and restoration of wild-type hematopoiesis, supporting potential disease-modifying effects.
Planned trials include phase III second-line ET in mid-2026 and second-line MF in H2 2026, with a first-line MF pivotal informed by ongoing 2026 data and development of a subcutaneous formulation.

1 day ago

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Incyte outlines 989 data and development plans at ASH 2025

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Product Launch

New Projects/Investments

FDA grants Breakthrough Therapy Designation for type 1 CALR-mutant essential thrombocythemia (ET); Incyte is finalizing dose selection and discussing a pivotal phase III trial design with the FDA .
Phase 1 monotherapy in relapsed/refractory myelofibrosis (52 patients) showed no dose-limiting toxicities or MTD reached; 42% achieved ≥25% spleen volume reduction (SVR25) and 33% achieved ≥35% (SVR35) at Week 24, with 93% reporting symptom improvement and a 56% anemia response rate.
Combination with ruxolitinib in 20 suboptimal responders yielded 50% SVR25 and 25% SVR35 at Week 24, with 81% experiencing symptom improvement and stable hemoglobin; one patient achieved a major anemia response.
Next steps: launch a Phase III trial in second-line ET by mid-2026 and a second-line myelofibrosis study in H2 2026 using IV dosing; a first-line MF pivotal trial will be informed by data in late 2026. A subcutaneous formulation via the EnFuse device will enter the clinic in early 2026 .

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Incyte updates 989 program with positive MF data and FDA breakthrough ET designation

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In relapsed/refractory myelofibrosis, monotherapy 989 achieved 42% SVR25 and 33% SVR35 at week 24, 39% TSS50 symptom improvement, 56% anemia response, and showed mutant CALR VAF reductions, with an acceptable safety profile and no dose-limiting toxicities.
Adding 989 to ruxolitinib in suboptimal responders resulted in 50% SVR25 and 25% SVR35 at week 24, 33% TSS50, stable hemoglobin, and 85%+ of patients remained on therapy, affirming combination tolerability and efficacy.
Incyte received Breakthrough Therapy Designation for mutant CALR type 1 essential thrombocythemia and plans a Phase III ET trial by mid-2026, a second-line myelofibrosis study in H2 2026, and a first-line MF pivotal trial informed by ongoing data expected in 2026.
A subcutaneous 989 formulation via the EnFuse device is slated to enter the clinic in early 2026, with the goal of integrating subQ dosing into pivotal studies as soon as feasible.

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Incyte receives FDA Breakthrough Therapy designation for rare blood cancer treatment

INCY

FDA granted Breakthrough Therapy designation to Incyte’s investigational antibody INCA033989 for essential thrombocythemia patients with a Type 1 CALR mutation unresponsive to standard treatments.
INCA033989 demonstrated in Phase 1 trials significant reductions in spleen size and symptoms, improvements in anemia, and no dose-limiting toxicities.
The antibody is being evaluated both as monotherapy and in combination with ruxolitinib in patients resistant or intolerant to JAK inhibitors.
Incyte’s strong financial position underpins a robust oncology and dermatology pipeline, including its partnered drug Jakafi with Novartis.

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Morningstar

Incyte details pipeline priorities at HealthCONx

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Product Launch

New Projects/Investments

Incyte is transitioning from its core Jakafi franchise to a diversified Heme-Onc and I&I portfolio, advancing seven priority programs including CALR-targeting antibody 989, JAK2 V617F inhibitors, three solid tumor assets (G12D, TGF-β/PD-1, CDK2), povorcitinib (NDA planned Q1 2026) and the recently launched Niktimvo for GVHD.
Antibody 989 shows a 55% anemia improvement rate (15% major, 40% minor) alongside spleen shrinkage and symptom relief in myelofibrosis, supporting proposed co-primary endpoints of spleen reduction and anemia in phase 3 design.
The JAK2 V617F small-molecule program is being reformulated to address exposure issues; Incyte also secured an option on Prelude’s compound with a different binding pocket to diversify its therapeutic approach.
Commercially, Jakafi XR is expected to launch mid-2026 with a 15–20% conversion rate (preserving ~$750 million in revenue), and Niktimvo is annualizing north of $200 million by Q4 2025.

5 days ago

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Incyte details pipeline priorities and Jakafi XR plan at Evercore ISI HealthCONx

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Product Launch

Incyte is transitioning from Jakafi to a broader heme-oncology and immunology portfolio to drive durable growth and cash flow beyond 2029.
The pipeline includes seven priority programs, notably 989 for CALR-mutated myelofibrosis, a JAK2 V617F inhibitor, three solid tumor candidates (G12D, TGF-β/PD-1, CDK2), and the I&I asset povorcitinib.
Early data for 989 show 55% anemia improvement in MF patients (15% major, 40% minor), supporting a potential phase III design with spleen shrinkage and anemia as co-primary endpoints.
A once-daily Jakafi XR is expected to launch mid-2026, with a target 20% patient switch to preserve roughly $750 million of Jakafi revenue through 2029.
Niktimvo is on track for a strong fourth quarter, annualizing north of $200 million, and retains activity post-Jakafi, with combination studies planned.

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Incyte outlines post-Jakafi growth strategy and pipeline at Citi Global Healthcare Conference

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Post-2029 growth: Incyte aims for a 15–20% five-year CAGR, with a core business (ex-Jakafi) projected to match Jakafi’s size by 2029, supported by 3–5 products each with >$1 B potential and >30% operating margins.
Jakafi XR launch: Planned for mid-2026, targeting 15–30% IR-to-XR conversion (≈20%) to preserve ~$0.75 B in Jakafi sales through LOE in 2029.
Pipeline expansion: Advancing seven late-stage assets, including 989 (mutant CalR antibody) entering Phase III in 2026 for ET/MF; oncology programs (KRAS G12D in pancreatic, TGFβR2/PD-1 bispecific in colorectal, CDK2 inhibitor in ovarian); and oral JAK inhibitors in I&I for HS, prurigo nodularis, and vitiligo.
Opzelura growth: FY25 sales of ~$650 M, projected 10% CAGR to 2030 (2× base), driven by U.S. penetration, new HS/PN indications, and EU moderate AD approval targeted mid-2026.
HS program povorcitinib: EU submission is in with U.S. filing planned early 2026; targeting > $1 B across HS, PN, and vitiligo based on strong HiSCR and rapid pain relief data.

6 days ago

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Incyte outlines FY 2025 growth strategy and pipeline updates at Citi Conference

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Product Launch

Guidance Update

New Projects/Investments

Transitioning from Jakafi to a diversified Hem/Onc and I&I portfolio, targeting 15–20% five-year CAGR post-2029 with 3–5 products each > $1 bn and > 30% operating margin.
Launching Jakafi XR mid-2026, aiming to convert ~20% of IR patients and preserve ≈ $750 m of Jakafi sales through 2029.
Advancing seven late-stage assets, led by 989 (mutant CalR antibody) showing rapid platelet normalization in ET and spleen/symptom responses in MF; Phase III trials in ET and MF to start in 2026.
Building I&I franchise: Opzelura reached $650 m in FY 2025 sales with a 10% CAGR to 2030 and EU moderate AD submission in; povorcitinib U.S. filing early 2026 targeting HS, PN, and vitiligo with > $1 bn combined opportunity.
Expanding solid tumor portfolio with pivotal trials in platinum-resistant ovarian (CDK2 inhibitor), KRAS G12D pancreatic (combos with Gem/Nab and FOLFIRINOX), and bispecific TGFβR2–PD1 in MSS colorectal—each moving into Phase III in 2026.

6 days ago

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Incyte outlines post-Jakafi growth and pipeline strategy

INCY

Product Launch

New Projects/Investments

Incyte plans to transition beyond Jakafi LOE by launching a once-daily XR formulation in mid-2026, targeting conversion of 15–30% of IR patients to preserve ~$750 million of sales through 2029.
The company’s core business (ex-Jakafi) plus seven late-stage pipeline assets aims for a 15–20% five-year CAGR post-2029; CalR antibody 989 will enter Phase III in 2026 with potential to replace Jakafi in ET and MF.
Opzelura achieved $650 million in FY 2025 sales and is projected to grow at 10% CAGR to 2030; EU approval for moderate AD is expected mid-2026, with a current 60/40 AD-Vitiligo revenue split.
Tropovo (povorcitinib) has filed in the EU and plans a U.S. submission in early 2026 for HS, PN, and Vitiligo, targeting over $1 billion in peak sales and offering rapid pain relief and high HiSCR rates.
In solid tumors, Incyte will initiate first-line pancreatic cancer trials with its KRAS G12D inhibitor in early 2026, advance a TGFβR2×PD-1 bispecific showing 15% response in MSS CRC, and progress a CDK2 inhibitor into Phase III for ovarian cancer maintenance.

6 days ago

Transcript

Incyte outlines post-Jakafi growth strategy and pipeline updates

INCY

Guidance Update

New Projects/Investments

CEO Bill Meury plans to transition Incyte from a Jakafi-centric company to a high-growth hem-onc and INI franchise, targeting five Phase III studies in 2026 across hematology, solid tumors, and INI ahead of Jakafi’s 2029 LOE.
The mCALR inhibitor 989 showed robust Phase I data in essential thrombocythemia (normalizing platelets) and myelofibrosis (≥30% SVR35, VAF reduction); pivotal second-line ET trials start in 2026, with second-line MF studies to follow.
In solid tumors, Incyte’s PD-1/TGF-β bispecific achieved ~15% response in late-line MSS colorectal cancer; it will advance with chemotherapy and bevacizumab into first-line trials, alongside a KRAS G12D inhibitor moving into first-line pancreatic cancer studies in 2026.
Incyte acquired Prelude’s JAK2 V617F pseudokinase inhibitors as external backups, aiming for comprehensive MPN coverage by early next decade (addressing CALR in 25–35% and V617F in remaining patients).
The JAK inhibitor povorcitinib is on track for a Q1 2026 NDA submission in hidradenitis suppurativa, with Phase III programs in prurigo nodularis and vitiligo and a potential early 2027 launch.

Nov 18, 2025, 11:00 AM

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