This section highlights FDA-related milestones and regulatory updates for drugs developed by Incyte (INCY).
Over the past two years, Incyte has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MRGPRX2, Niktimvo, povorcitinib, Retifanlimab, ruxolitinib, tafasitamab, and Tafasitamab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
MRGPRX2 - FDA Regulatory Timeline and Events
MRGPRX2 is a drug developed by Incyte for the following indication: In chronic spontaneous urticaria.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MRGPRX2
- Announced Date:
- November 18, 2024
- Indication:
- In chronic spontaneous urticaria
Announcement
Incyte announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU).
AI Summary
Incyte announced it will pause enrollment in its ongoing Phase 2 study of MRGPRX2 (INCB000262) for patients with chronic spontaneous urticaria. This decision comes after certain in vivo preclinical toxicology findings were observed. The company has shared these findings with the FDA and plans to work closely with the agency to decide on the next steps. Enrollment in the other INCB000262 proof-of-concept studies is already complete, and the clinical data collected will help guide the future development of the drug as well as potential backup molecules.
Incyte remains committed to patient safety and the rigorous assessment of its therapies. The company is focused on ensuring that its clinical developments meet the highest safety standards before proceeding further in the program.
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Niktimvo - FDA Regulatory Timeline and Events
Niktimvo is a drug developed by Incyte for the following indication: In Chronic Graft-Versus-Host Disease.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Niktimvo
- Announced Date:
- January 15, 2025
- Indication:
- In Chronic Graft-Versus-Host Disease
Announcement
Incyte and Syndax Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr) in 9 mg and 22 mg vial sizes.
AI Summary
Incyte and Syndax Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Niktimvo™ (axatilimab-csfr) in 9 mg and 22 mg vial sizes. This new treatment is approved for chronic graft-versus-host disease (GVHD) in adult and pediatric patients weighing at least 40 kg who have not responded to at least two prior systemic therapies. Niktimvo is the first and only approved treatment that targets the colony stimulating factor-1 receptor (CSF-1R) to help reduce the inflammation and fibrosis that drive the disease. The approval was supported by positive clinical data from the AGAVE-201 trial, which demonstrated durable responses in various patient subgroups. The companies expect orders to begin in early February, marking a significant step forward in addressing the unmet medical needs of chronic GVHD patients.
Read Announcement- Drug:
- Niktimvo
- Announced Date:
- September 18, 2024
- Indication:
- In Chronic Graft-Versus-Host Disease
Announcement
Incyte and Syndax Pharmaceuticals announced that results from the pivotal Phase 2 AGAVE-201 trial of Niktimvo™ (axatilimab-csfr), an anti-CSF-1R antibody, in adult and pediatric patients with recurrent/refractory active chronic graft-versus-host disease (GVHD) who had received at least two prior lines of systemic therapy were published in The New England Journal of Medicine.1
AI Summary
Incyte and Syndax Pharmaceuticals announced that the pivotal Phase 2 AGAVE-201 trial results for Niktimvo™ (axatilimab-csfr) have been published in The New England Journal of Medicine. This study tested Niktimvo, an anti-CSF-1R antibody, in adult and pediatric patients with recurrent or refractory chronic graft-versus-host disease (GVHD) who had already received at least two prior systemic therapies. A total of 241 patients from 121 sites in 16 countries participated in the trial. Notably, 74% of patients in the 0.3 mg/kg every two weeks group reached a complete or partial response within the first six months of treatment. The data suggest that Niktimvo can target the key disease mechanisms in chronic GVHD, offering rapid and durable responses for patients who have few other treatment options.
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povorcitinib - FDA Regulatory Timeline and Events
povorcitinib is a drug developed by Incyte for the following indication: AK1 inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- povorcitinib
- Announced Date:
- March 17, 2025
- Indication:
- AK1 inhibitor
Announcement
Incyte announced positive topline results from its pivotal Phase 3 STOP-HS clinical trial program evaluating the safety and efficacy of povorcitinib (INCB054707), an oral small-molecule JAK1 inhibitor, in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS).
AI Summary
Incyte announced positive topline results from its pivotal Phase 3 STOP-HS clinical trial program evaluating povorcitinib, an oral JAK1 inhibitor, for treating moderate to severe hidradenitis suppurativa (HS) in adults. In two key studies, STOP-HS1 and STOP-HS2, both the 45 mg and 75 mg doses met the primary endpoint, with a significantly higher number of patients achieving at least a 50% reduction in abscess and inflammatory nodule count compared to placebo. Additionally, patients experienced a rapid onset of response with noticeable reductions in skin pain and flare-ups. The safety profile of povorcitinib was favorable, with no new safety concerns observed. These promising results support Incyte’s planned regulatory submission for povorcitinib worldwide, offering a potential new oral treatment option for adults suffering from the chronic and challenging condition of HS.
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Retifanlimab - FDA Regulatory Timeline and Events
Retifanlimab is a drug developed by Incyte for the following indication: Metastatic squamous cell carcinoma of the anal canal.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Retifanlimab
- Announced Date:
- June 12, 2025
- Indication:
- Metastatic squamous cell carcinoma of the anal canal
Announcement
Incyte announced that primary results from the Phase 3 POD1UM-303/InterAACT 2 trial of retifanlimab (Zynyz®), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) in adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal cancer (SCAC) who have not been previously treated with systemic chemotherapy, were published in The Lancet.1
AI Summary
Incyte announced that the Phase 3 POD1UM-303/InterAACT 2 trial results were published in The Lancet. The trial evaluated retifanlimab (Zynyz®), a humanized monoclonal antibody that targets PD-1, combined with platinum-based chemotherapy (carboplatin and paclitaxel) in adult patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) who had not received prior systemic chemotherapy. The study met its primary endpoint, showing a significant 37% reduction in the risk of disease progression or death compared to the control group. In addition, patients receiving the combination treatment enjoyed improved progression-free survival and a six-month difference in overall survival at the interim analysis. These promising results offer hope for a patient population that previously had limited treatment options for advanced SCAC.
Read Announcement- Drug:
- Retifanlimab
- Announced Date:
- December 7, 2024
- Indication:
- Metastatic squamous cell carcinoma of the anal canal
Announcement
Incyte announced results from the Phase 3 POD1UM-304 trial of retifanlimab (Zynyz®), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with platinum-based chemotherapy for the treatment of adults with previously untreated non-squamous and squamous metastatic non-small cell lung cancer (NSCLC) not harboring a driver mutation.
AI Summary
Incyte announced positive results from its Phase 3 POD1UM-304 trial, which evaluated retifanlimab (Zynyz®) combined with platinum-based chemotherapy in adults with previously untreated non-squamous and squamous metastatic non-small cell lung cancer (NSCLC) without a driver mutation. The trial achieved its primary endpoint by significantly improving overall survival; patients receiving the retifanlimab and chemotherapy combination had a median overall survival of 18.1 months compared to 13.4 months for those receiving placebo and chemotherapy. Key secondary endpoints were also met, with improvements in progression-free survival and overall response rate. These strong results support Incyte’s plan to file a supplemental Biologics License Application with the FDA in 2025, adding promising evidence that retifanlimab could become an important treatment option for hard-to-treat NSCLC.
Read Announcement- Drug:
- Retifanlimab
- Announced Date:
- September 14, 2024
- Indication:
- Metastatic squamous cell carcinoma of the anal canal
Announcement
Incyte announced results from the Phase 3 POD1UM-303/InterAACT2 trial of retifanlimab (Zynyz®), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with platinum-based chemotherapy (carboplatin–paclitaxel) for the treatment of adults with inoperable locally recurrent or metastatic squamous cell anal carcinoma (SCAC).
AI Summary
Incyte announced promising results from its Phase 3 POD1UM-303/InterAACT2 trial evaluating retifanlimab (Zynyz®), a humanized monoclonal antibody that targets programmed death receptor-1 (PD-1). The trial examined the use of retifanlimab in combination with platinum-based chemotherapy—specifically carboplatin and paclitaxel—for treating adults with inoperable, locally recurrent, or metastatic squamous cell anal carcinoma (SCAC). These findings indicate that the immunotherapy plus chemotherapy combination may offer improved disease control and a new treatment option for patients with this aggressive cancer.
The data from the study support further development of retifanlimab as part of SCAC treatment, potentially filling a crucial gap for patients who have limited options. The results add to the growing evidence that combining immunotherapy with standard chemotherapy could enhance outcomes in difficult-to-treat malignancies.
Read Announcement- Drug:
- Retifanlimab
- Announced Date:
- September 14, 2024
- Indication:
- Metastatic squamous cell carcinoma of the anal canal
Announcement
Incyte Late-breaking data presented at the European Society for Medical Oncology (ESMO) Congress 2024 support the planned U.S. filing of a supplemental Biologics License Application (sBLA) for retifanlimab in SCAC by year-end 2024
AI Summary
Incyte presented late-breaking data at the European Society for Medical Oncology (ESMO) Congress 2024 that supports its plan to file a supplemental Biologics License Application (sBLA) in the United States for retifanlimab in SCAC by year-end 2024. The data add compelling evidence of the drug’s potential benefits as a treatment option for this indication, reinforcing Incyte’s commitment to advancing therapies for cancers with limited treatment options.
The promising findings showcased at ESMO underscore the strength of Incyte’s clinical research program and provide important momentum toward regulatory milestones. With this encouraging data, Incyte is poised to move forward with its planned registration pathway, reflecting its dedication to addressing unmet medical needs in oncology and offering hope to patients with SCAC.
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ruxolitinib cream - FDA Regulatory Timeline and Events
ruxolitinib cream is a drug developed by Incyte for the following indication: Atopic dermatitis (AD), a type of eczema.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ruxolitinib cream
- Announced Date:
- June 20, 2025
- Indication:
- Atopic dermatitis (AD), a type of eczema
Announcement
Incyte announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura®), a topical Janus kinase (JAK) inhibitor, for the treatment of children 2-11 years old with mild to moderate atopic dermatitis (AD).
AI Summary
Incyte announced that the FDA has extended the review period for its supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura®). This extension applies to the cream’s evaluation as a treatment for children ages 2 to 11 with mild to moderate atopic dermatitis (AD). The FDA has moved the Prescription Drug User Fee Act (PDUFA) action date to September 19, 2025, providing extra time to review additional chemistry, manufacturing, and controls (CMC) data for the 0.75% formulation.
This extra review time will help ensure that all aspects of the cream’s production and quality are thoroughly assessed. Incyte remains optimistic that this non-steroidal, topical treatment could become a valuable option for managing AD in young patients, helping address an important medical need for children suffering from this chronic skin condition.
Read Announcement- Drug:
- ruxolitinib cream
- Announced Date:
- June 15, 2025
- Indication:
- Atopic dermatitis (AD), a type of eczema
Announcement
Incyte announced the first clinical data from two studies evaluating the safety, tolerability and efficacy of INCA033989, a novel, first in class, Incyte-discovered, targeted monoclonal antibody in patients with mutant calreticulin (mutCALR)-expressing myeloproliferative neoplasms (MPNs).
AI Summary
Incyte announced the first clinical data on INCA033989, a novel, first-in-class monoclonal antibody that targets mutant calreticulin (mutCALR) cells in patients with myeloproliferative neoplasms. The studies focused on high-risk essential thrombocythemia patients who had resistance or intolerance to prior treatments. Results showed that at doses of 400 mg and above, 86% of patients achieved a complete or partial hematologic response, with 82% reaching a complete response. Additionally, 89% of the evaluated patients experienced a reduction in the mutCALR variant allele frequency, which correlated with improved blood counts. The data also revealed that INCA033989 selectively targets and eliminates cancer-causing cells while sparing healthy cells and restoring normal blood cell production. No dose-limiting toxicities were reported, and most patients remained on treatment, suggesting a favorable safety profile.
Read Announcement- Drug:
- ruxolitinib cream
- Announced Date:
- March 8, 2025
- Indication:
- Atopic dermatitis (AD), a type of eczema
Announcement
Incyte announced results from its pivotal Phase 3 TRuE-PN clinical trial program –TRuE-PN1 and TRuE-PN2 studies – evaluating the safety and efficacy of twice-daily ruxolitinib cream 1.5% (Opzelura®), a topical JAK1/2 inhibitor, in adult patients (≥18 years) with prurigo nodularis (PN).
AI Summary
Incyte announced positive results from its pivotal Phase 3 TRuE-PN clinical trial program, which includes the TRuE-PN1 and TRuE-PN2 studies, assessing the safety and efficacy of twice-daily ruxolitinib cream 1.5% (Opzelura®) in adults with prurigo nodularis (PN). In the TRuE-PN1 study, the cream met all primary and key secondary endpoints. Significantly more PN patients experienced a marked reduction in itch and improvements in skin lesions compared to the vehicle control, with benefits noted as early as Day 7. Although the TRuE-PN2 study showed a positive trend on key secondary endpoints, its primary endpoint did not reach statistical significance due to a high placebo response. These promising results support further discussions with regulatory authorities and may lead to a much-needed new topical treatment option for patients with PN.
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tafasitamab (Monjuvi®) - FDA Regulatory Timeline and Events
tafasitamab (Monjuvi®) is a drug developed by Incyte for the following indication: In patients with relapsed or refractory follicular lymphoma (FL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- tafasitamab (Monjuvi®)
- Announced Date:
- December 10, 2024
- Indication:
- In patients with relapsed or refractory follicular lymphoma (FL).
Announcement
Incyte announced additional results from the pivotal Phase 3 inMIND trial evaluating treatment with tafasitamab (Monjuvi®), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL).
AI Summary
Incyte announced additional results from the pivotal Phase 3 inMIND trial, which evaluated tafasitamab (Monjuvi®) combined with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL). The trial met its primary endpoint by showing a statistically significant improvement in progression-free survival (PFS). Patients receiving tafasitamab achieved a median PFS of 22.4 months compared to 13.9 months for those in the control group—a 57% reduction in the risk of progression, relapse, or death. The benefit was confirmed by both investigator assessment and an independent review committee, with consistent results observed across various patient subgroups. These positive findings, presented at the 2024 ASH Annual Meeting, support plans to file a supplemental Biologics License Application (sBLA) in the U.S. by the end of 2024, offering new hope for FL patients.
Read Announcement- Drug:
- tafasitamab (Monjuvi®)
- Announced Date:
- August 16, 2024
- Indication:
- In patients with relapsed or refractory follicular lymphoma (FL).
Announcement
Incyte Corporation released topline results from the pivotal Phase 3 inMIND trial evaluating the efficacy and safety of Monjuvi (tafasitamab) and lenalidomide as an add-on to rituximab compared with lenalidomide alone as an add-on to rituximab in patients with relapsed or refractory follicular lymphoma or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL).
AI Summary
Incyte Corporation has announced positive topline results from its pivotal Phase 3 inMIND trial, which evaluated the efficacy and safety of Monjuvi® (tafasitamab) combined with lenalidomide and rituximab versus lenalidomide and rituximab alone. The trial involved patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma. Notably, the study met its primary endpoint for progression-free survival, demonstrating that adding Monjuvi to the treatment regimen may significantly improve patient outcomes. In addition, the trial met key secondary endpoints, including improved response rates, with no new safety concerns identified during the study. Based on these promising results, Incyte expects to file a supplemental Biologics License Application by the end of the year. This development could represent an important new treatment option for patients who experience relapse after prior therapies.
Read Announcement- Drug:
- tafasitamab (Monjuvi®)
- Announced Date:
- August 15, 2024
- Indication:
- In patients with relapsed or refractory follicular lymphoma (FL).
Announcement
Incyte announces positive topline results from the pivotal Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, or placebo in combination with lenalidomide and rituximab compared to lenalidomide and rituximab alone in patients with relapsed or refractory follicular lymphoma (FL).
AI Summary
Incyte announced positive topline results from its Phase 3 inMIND trial. The study evaluated tafasitamab (Monjuvi®) in combination with lenalidomide and rituximab versus lenalidomide and rituximab alone in patients with relapsed or refractory follicular lymphoma (FL). The trial met its primary endpoint of progression-free survival (PFS) by investigator assessment in FL patients. It also met key secondary endpoints, including PFS in the overall study population, and PET-complete response rate in the FDG-avid FL subgroup. The PFS results from a blinded independent review were consistent with investigator assessments, and no new safety concerns were observed with tafasitamab. Based on these promising outcomes, Incyte expects to file a supplemental Biologics License Application for tafasitamab in treatment of FL patients by the end of the year.
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Tafasitamab + (Lenalidomide and Rituximab) - FDA Regulatory Timeline and Events
Tafasitamab + (Lenalidomide and Rituximab) is a drug developed by Incyte for the following indication: Relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tafasitamab + (Lenalidomide and Rituximab)
- Announced Date:
- November 25, 2024
- Indication:
- Relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL)
Announcement
Incyte announced that the Company will present new data from across its oncology portfolio at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego.
AI Summary
Incyte announced that it will present new oncology data at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego. The company’s portfolio will be highlighted through twenty presentations, which include late-breaking, oral, and poster sessions, covering data from several of its medicines. A key highlight is the late-breaking oral presentation on tafasitamab from the Phase 3 inMIND study. This study focuses on tafasitamab’s use in relapsed or refractory follicular lymphoma, offering promising insight into treatment options for patients with limited alternatives.
These presentations underscore Incyte’s commitment to advancing cancer treatment through rigorous clinical research. The data will be shared during dedicated sessions at the conference and discussed further during a virtual analyst and investor event on December 12, 2024. This approach reinforces the company’s innovative strategies in oncology care.
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Zynyz - FDA Regulatory Timeline and Events
Zynyz is a drug developed by Incyte for the following indication: For Advanced Anal Cancer Patients in the United States.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Zynyz
- Announced Date:
- May 15, 2025
- Indication:
- For Advanced Anal Cancer Patients in the United States
Announcement
Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz® (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
AI Summary
Incyte announced that the U.S. FDA has approved Zynyz® (retifanlimab-dlwr), a humanized monoclonal antibody targeting PD-1, in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). This approval marks the first time a PD-1 inhibitor has been approved for this challenging type of anal cancer, offering a new treatment option for patients who previously had few alternatives. Clinical trial results showed that the combination significantly improved progression-free and overall survival, with a notable reduction in the risk of disease progression. This new therapy gives hope to patients battling advanced anal cancer and represents a major advancement in treatment options for this rare disease.
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