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Incyte's Rare Blood Cancer Therapy Gets FDA's Breakthrough Status
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Key Takeaways
Incyte earned FDA Breakthrough status for INCA033989 to treat essential thrombocythemia patients.
Early phase I data showed strong platelet normalization and tolerability across tested doses.
Updated results also showed meaningful benefits in CALR-mutant myelofibrosis, alone or with Jakafi.
Incyte (INCY - Free Report) announced that the FDA has granted the Breakthrough Therapy designation to its investigational, first-in-class, mutCALR-targeted monoclonal antibody, INCA033989, to treat patients with essential thrombocythemia (ET).
The intended patient population includes those harboring a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy.
Benefits of the FDA’s Breakthrough Therapy Designation Grant
The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when early clinical evidence suggests the drug may significantly improve over existing treatments on one or more important clinical measures. Drugs with this designation receive more intensive guidance and organizational support from senior FDA managers.
The FDA’s decision was based on early phase I data for INCA033989 in ET patients with a Type 1 CALR mutation available at the time of submission. Per the preliminary results, presented at the 2025 European Hematology Association Congress, the candidate was well tolerated and showed rapid and sustained normalization of platelet counts across tested doses, with stronger responses observed at higher dose levels across both mutation subtypes.
ET is a chronic myeloproliferative neoplasm (MPN), a form of rare blood cancer, marked by sustained overproduction of platelets in the bone marrow. CALR mutations are the second most common disease-driving alteration, seen in about 25% of ET patients. Among these, the 52-bp Type 1 CALR deletion, present in roughly 55% of CALR-mutant cases, is linked to the highest risk of progression to myelofibrosis (MF) among all ET patients.
In the past year, shares of Incyte have rallied 42.2% compared with the industry’s 9.3% growth.
Image Source: Zacks Investment Research
In a separate press release, Incyte announced updated results from the dose escalation portion of two phase I studies of INCA033989 for mutCALR-expressing MPN patients who have progressed to MF. The data was presented at the 2025 American Society of Hematology conference. Per the data readout, INCA033989 delivered rapid and meaningful clinical benefits in patients with CALR-mutant MF, both as monotherapy and in combination with Jakafi (ruxolitinib).
Treatment resulted in robust spleen volume reductions, broad symptom improvement, and notable anemia responses, including in JAK inhibitor–naïve patients and those resistant or intolerant to prior JAK therapy. Notably, most patients also demonstrated reductions in mutCALR variant allele frequency, alongside exploratory bone marrow findings consistent with disease-modifying activity. The antibody was well tolerated across a wide dose range, with no dose-limiting toxicities or maximum tolerated dose reached, reinforcing its favorable safety profile.
Incyte’s Jakafi is an FDA-approved JAK1/JAK2 inhibitor indicated for adults with polycythemia vera who are resistant or intolerant to hydroxyurea, and for intermediate- or high-risk MF, including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF in adults. It is also approved for treating steroid-refractory acute graft-versus-host disease (GVHD) and chronic GVHD after failure of prior systemic therapies in adult and pediatric patients aged 12 and older.
INCY’s Next Steps in Developing This Blood Cancer Therapy
Looking ahead, Incyte aims to initiate a registrational phase III program for INCA033989 in mid-2026, evaluating the therapy in patients with both Type 1 and non–Type 1 CALR mutations, who are resistant or intolerant to at least one cytoreductive therapy, expanding its potential reach across the ET population.
This step will follow regulatory alignment anticipated in the first half of next year, marking a key milestone in the program’s clinical development roadmap.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.83 to $2.87. EPS estimates for 2026 have moved up from $2.48 to $2.88 during the same period. CRMD stock has gained 13% in the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $7.28 to $7.54 for 2025. During the same time, EPS estimates for 2026 have improved from $7.78 to $8.15. In the past year, shares of ANIP have rallied 40.9%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, EPS estimates for 2026 have increased from 9 cents to 41 cents. In the past year, shares of ARQT have surged 148%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.
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Incyte's Rare Blood Cancer Therapy Gets FDA's Breakthrough Status
Key Takeaways
Incyte (INCY - Free Report) announced that the FDA has granted the Breakthrough Therapy designation to its investigational, first-in-class, mutCALR-targeted monoclonal antibody, INCA033989, to treat patients with essential thrombocythemia (ET).
The intended patient population includes those harboring a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy.
Benefits of the FDA’s Breakthrough Therapy Designation Grant
The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when early clinical evidence suggests the drug may significantly improve over existing treatments on one or more important clinical measures. Drugs with this designation receive more intensive guidance and organizational support from senior FDA managers.
The FDA’s decision was based on early phase I data for INCA033989 in ET patients with a Type 1 CALR mutation available at the time of submission. Per the preliminary results, presented at the 2025 European Hematology Association Congress, the candidate was well tolerated and showed rapid and sustained normalization of platelet counts across tested doses, with stronger responses observed at higher dose levels across both mutation subtypes.
ET is a chronic myeloproliferative neoplasm (MPN), a form of rare blood cancer, marked by sustained overproduction of platelets in the bone marrow. CALR mutations are the second most common disease-driving alteration, seen in about 25% of ET patients. Among these, the 52-bp Type 1 CALR deletion, present in roughly 55% of CALR-mutant cases, is linked to the highest risk of progression to myelofibrosis (MF) among all ET patients.
In the past year, shares of Incyte have rallied 42.2% compared with the industry’s 9.3% growth.
Image Source: Zacks Investment Research
In a separate press release, Incyte announced updated results from the dose escalation portion of two phase I studies of INCA033989 for mutCALR-expressing MPN patients who have progressed to MF. The data was presented at the 2025 American Society of Hematology conference. Per the data readout, INCA033989 delivered rapid and meaningful clinical benefits in patients with CALR-mutant MF, both as monotherapy and in combination with Jakafi (ruxolitinib).
Treatment resulted in robust spleen volume reductions, broad symptom improvement, and notable anemia responses, including in JAK inhibitor–naïve patients and those resistant or intolerant to prior JAK therapy. Notably, most patients also demonstrated reductions in mutCALR variant allele frequency, alongside exploratory bone marrow findings consistent with disease-modifying activity. The antibody was well tolerated across a wide dose range, with no dose-limiting toxicities or maximum tolerated dose reached, reinforcing its favorable safety profile.
Incyte’s Jakafi is an FDA-approved JAK1/JAK2 inhibitor indicated for adults with polycythemia vera who are resistant or intolerant to hydroxyurea, and for intermediate- or high-risk MF, including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF in adults. It is also approved for treating steroid-refractory acute graft-versus-host disease (GVHD) and chronic GVHD after failure of prior systemic therapies in adult and pediatric patients aged 12 and older.
INCY’s Next Steps in Developing This Blood Cancer Therapy
Looking ahead, Incyte aims to initiate a registrational phase III program for INCA033989 in mid-2026, evaluating the therapy in patients with both Type 1 and non–Type 1 CALR mutations, who are resistant or intolerant to at least one cytoreductive therapy, expanding its potential reach across the ET population.
This step will follow regulatory alignment anticipated in the first half of next year, marking a key milestone in the program’s clinical development roadmap.
Incyte Corporation Price and Consensus
Incyte Corporation price-consensus-chart | Incyte Corporation Quote
INCY’s Zacks Rank and Stocks to Consider
Incyte currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector include CorMedix (CRMD - Free Report) , Arcutis Biotherapeutics (ARQT - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While CRMD and ANIP sport a Zacks Rank #1 (Strong Buy) each, ARQT carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.83 to $2.87. EPS estimates for 2026 have moved up from $2.48 to $2.88 during the same period. CRMD stock has gained 13% in the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $7.28 to $7.54 for 2025. During the same time, EPS estimates for 2026 have improved from $7.78 to $8.15. In the past year, shares of ANIP have rallied 40.9%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, EPS estimates for 2026 have increased from 9 cents to 41 cents. In the past year, shares of ARQT have surged 148%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.