Incyte (NASDAQ:INCY) executives outlined the company’s near-term launch priorities and mid-stage pipeline plans during a presentation at the Barclays conference, emphasizing a strategy to sustain growth ahead of the loss of exclusivity for Jakafi in 2029.
Chief Executive Officer Bill Meury said the company views its business across three therapeutic areas: hematology, an emerging solid tumor oncology franchise, and immunology. Hematology remains “the central identity of the company,” while solid tumors “started to declare itself in 2025” with programs that have since moved into frontline phase III studies. In immunology, Incyte’s franchise is currently anchored by the topical JAK inhibitor Opzelura, with the company expecting an approval for povorcitinib “at least by the end of 2026, early 2027.”
Growth plan beyond Jakafi
He described the company in two parts: a “core business, ex-Jakafi” and the pipeline. The core business generated about $1.2 billion in 2025 and was up 50% year over year, according to Meury. He said Incyte expects that business could grow at a 15% to 20% five-year CAGR and approach $3 billion to $4 billion by 2030, though he noted growth is not linear.
Meury highlighted four product launches over the next 12 to 18 months as important drivers for the core business:
- Jakafi XR
- A frontline DLBCL opportunity for Monjuvi (tafasitamab), following study results the company has released
- An Opzelura moderate atopic dermatitis indication in Europe
- Povorcitinib
On business development, Meury said it would be used “as a multiplier” to extend or strengthen the core business, rather than to fill a revenue gap.
INCB0989 (mCALR antibody) and phase III plans
Discussing myeloproliferative neoplasms (MPNs), Meury and Head of R&D Pablo Cagnoni reviewed data presented at the end of 2025 at ASH for INCB0989, a monoclonal antibody targeting mutant calreticulin (mCALR), in both myelofibrosis (MF) and essential thrombocythemia (ET).
Meury said the phase I program helped address key “threshold questions” and pointed to a “very high complete hematological response” in ET along with an impact on variant allele frequency (VAF). In MF, he cited spleen volume reduction, symptom relief, and anemia response, characterizing the profile as “frontline efficacy in a second-line setting.” He contrasted this with what he described as a common “trade-off” with JAK inhibitors in MF, where dose increases may improve symptoms but worsen anemia.
Cagnoni said Incyte has already begun discussions with the FDA and is finalizing the protocol for a second-line ET phase III study, with an intent to start at least two phase III studies this year. Key design items under discussion include:
- Population: “All comers,” including type 1, type 2, and non-type 1/type 2 patients
- Dosing strategy: Reflecting observed dose-response differences, including that type 1 patients appear to respond at lower doses
- Primary endpoint: A version of complete hematologic response
- Timing and additional measures: Potentially accelerating the readout from the traditional 52 weeks and incorporating VAF “in some manner” as an endpoint for clinical validation
Cagnoni said the company expected to finalize those elements by the end of the month and provide full study design details on the next earnings call in the second half of April. In MF, he said Incyte intends to start a second-line study in the second half of the year and is pushing to start a first-line MF study “very late this year or the next year.”
He also noted a subcutaneous formulation of INCB0989 is set to enter the clinic “this month” in healthy volunteers, with a plan to move to patients as soon as possible. By the second half of the year, the company expects to have both the formulation and a subcutaneous device, which it aims to incorporate into pivotal trials.
Anemia response as a potential differentiator in MF
Meury and Cagnoni emphasized the anemia response observed with INCB0989 in MF. Meury described anemia as a negative prognostic indicator in MF and said INCB0989 appears not only to avoid anemia but to restore normal bone marrow function and red blood cell production.
Cagnoni said more than 50% of patients showed meaningful improvements in anemia, describing increases of more than 1.5 to 2 grams in hemoglobin over time. He said analyses comparing patients with or without a prior Jakafi washout suggested the anemia benefit was not simply due to discontinuing Jakafi, and he pointed to bone marrow findings showing a shift toward normal red cell production.
Other pipeline updates: JAK2 V617F, DLBCL, immunology, and solid tumors
On INCB160058, Incyte’s JAK2 V617F inhibitor program, Meury said the mechanism is strong but acknowledged challenges with a narrow therapeutic window and formulation issues related to solubility. He said the company introduced a solid dispersion formulation in the current quarter and expects data by year-end, adding he is “cautiously optimistic” healthy volunteer data will support exposures needed to see clinical activity. He also cited internal backup molecules and an option agreement with Prelude for access to its V617F inhibitor programs.
In frontline diffuse large B-cell lymphoma (DLBCL), Meury said the goal remains cure but that 40% of patients still do not achieve it. He said Incyte has seen a “strong efficacy signal” in progression-free survival and a manageable safety profile, with more subgroup data expected in 2026. He described Monjuvi’s potential role as an add-on or intensification strategy in the community setting and said Incyte plans to submit to regulators in the first half of 2026, with a possible approval “at the end of 2026, early 2027.”
In immunology, executives discussed povorcitinib in prurigo nodularis (PN), hidradenitis suppurativa (HS), and vitiligo. Meury said he does not view treatment options as an “either/or” fight, but argued there is a gap for an oral anti-inflammatory in these conditions, noting there is no FDA-approved oral treatment in PN. Cagnoni highlighted speed of itch improvement with povorcitinib, citing two-thirds of the effect by about two weeks and a median time to a four-point or greater itch improvement of 19 days at higher doses, which he contrasted with what he described as slower itch relief with Dupixent.
For vitiligo, Meury said Opzelura has penetrated a significant portion of diagnosed and treated patients with body surface area (BSA) involvement under 5%, while an oral option would be more practical above 5% BSA. He said Incyte believes having a “topical to oral backbone” could be an advantage if phase III data are convincing.
In solid tumors, Cagnoni discussed the company’s TGFβR2xPD-1 bispecific program in microsatellite-stable (MSS) colorectal cancer. He said the phase I program included 100 patients and showed an approximate 15% response rate in third- and fourth-line disease, including responses in patients with liver metastases, in contrast to published PD-1 inhibitor monotherapy response rates of zero in MSS colorectal cancer. He said a phase III study in combination with FOLFOX/bevacizumab has started accruing, and Incyte expects to provide a data update on the chemotherapy combination around mid-year.
On Incyte’s KRAS G12D inhibitor in pancreatic cancer, Cagnoni said the company has shown it can combine the agent with Gem/Nab and FOLFIRINOX in first-line settings and is initiating a phase III trial in first-line pancreatic cancer. He said an update on combination data is expected in the second half of the year, along with plans for potential expansion into additional indications and combinations.
About Incyte (NASDAQ:INCY)
Incyte Corporation is a Wilmington, Delaware–based biopharmaceutical company focused on the discovery, development and commercialization of novel therapies in oncology and inflammation. Since its founding in 2002, Incyte has grown from a small research organization into a global enterprise, advancing a portfolio of internally developed and partnered assets. The company’s research and development efforts center on small-molecule drugs and biologics that modulate critical signaling pathways implicated in cancer, autoimmune disorders and rare diseases.
The company’s flagship product is Jakafi® (ruxolitinib), a Janus kinase (JAK) inhibitor approved for the treatment of myelofibrosis and polycythemia vera.
