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
Opzelura®, Zynyz, Ruxolitinib, tafasitamab, povorcitinib, Baricitinib, and tafasitamab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Opzelura® (Ruxolitinib) FDA Regulatory Timeline and Events
Opzelura® (Ruxolitinib) is a drug developed by Incyte for the following indication: treatment of mild to moderate atopic dermatitis.
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:
- Opzelura® (Ruxolitinib)
- Announced Date:
- May 7, 2026
- Indication:
- treatment of mild to moderate atopic dermatitis
Announcement
Incyte announced final 24-week data from the Phase 3 TRuE-AD4 study evaluating the efficacy and safety of Opzelura® (ruxolitinib) cream in adults with moderate atopic dermatitis (AD) who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs).
AI Summary
Incyte announced final 24-week results from the Phase 3 TRuE-AD4 study evaluating the efficacy and safety of Opzelura (ruxolitinib) cream in adults with moderate atopic dermatitis who had an inadequate response, intolerance, or contraindication to topical corticosteroids and topical calcineurin inhibitors. The trial assessed an as-needed application regimen over six months in this treatment-challenged population.
Opzelura as-needed was well tolerated through 24 weeks, with few application-site reactions reported (1.7%) and no new safety signals identified during the study period. The most common treatment-emergent adverse events were upper respiratory tract infection (10.6%) and nasopharyngitis (6.3%).
These final safety findings add to the overall trial assessment of efficacy and support a consistent tolerability profile for Opzelura over six months in adults with moderate atopic dermatitis who require alternatives to standard topical therapies. Incyte will use the TRuE-AD4 data to inform ongoing development and clinical use decisions.
Read Announcement- Drug:
- Opzelura® (Ruxolitinib)
- Announced Date:
- October 25, 2025
- Indication:
- treatment of mild to moderate atopic dermatitis
Announcement
Incyte announced new data from the Phase 3b TRuE-AD4 study evaluating the efficacy and safety of Opzelura® (ruxolitinib cream) in adults with moderate atopic dermatitis (AD) who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs).
AI Summary
The Phase 3b TRuE-AD4 study tested Opzelura® (ruxolitinib cream) in adults with moderate atopic dermatitis who did not respond to or could not use topical corticosteroids or calcineurin inhibitors. The trial enrolled 241 participants treated twice daily with either Opzelura or a non-medicated vehicle cream over eight weeks.
By Week 8, 70% of patients using Opzelura achieved at least a 75% improvement in their Eczema Area and Severity Index (EASI75) compared to 18.5% with vehicle. Investigator’s Global Assessment Treatment Success (IGA-TS) was reached by 61.3% versus 13.6%. Itch relief was notable as early as Day 2, and 62.5% of Opzelura users had a four-point itch reduction by Week 8 versus 19.8% with vehicle.
Opzelura was well tolerated, with no serious infections, cardiovascular events, malignancies or blood clots in the controlled period. The most common side effect was application site acne (4.4%). Based on these results, Incyte plans to file a Type II variation application for ruxolitinib cream 1.5% in the European Union by year end.
Read Announcement- Drug:
- Opzelura® (Ruxolitinib)
- Announced Date:
- September 18, 2025
- Indication:
- treatment of mild to moderate atopic dermatitis
Announcement
Incyte y announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura® (ruxolitinib) cream 1.5%, a topical Janus kinase (JAK) inhibitor, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended.
AI Summary
Incyte announced that the FDA has approved Opzelura® (ruxolitinib) cream 1.5%, the first topical Janus kinase (JAK) inhibitor for children with mild to moderate atopic dermatitis (AD). This approval covers short-term and non-continuous chronic use in non-immunocompromised patients aged two years and older whose disease is not well controlled with prescription topical therapies, or when those therapies are not recommended.
The FDA decision was based on data from the pivotal Phase 3 TRuE-AD3 trial, in which Opzelura achieved significantly higher Investigator’s Global Assessment treatment success and EASI 75 response rates compared to vehicle. No new safety signals emerged during the study, and the most common adverse reaction was upper respiratory tract infection. Incyte sees this approval as a milestone that provides a steroid-free, targeted option to help improve symptoms and quality of life for young children and their families managing AD.
Read Announcement
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 4, 2026
- Indication:
- For Advanced Anal Cancer Patients in the United States
Announcement
MacroGenics, Inc. announced that it entered into an expanded royalty purchase agreement with Sagard in exchange for a capped royalty interest on future global net sales of ZYNYZ® (retifanlimab-dlwr). MacroGenics and Sagard entered into the initial ZYNYZ royalty purchase agreement in June 2025.
AI Summary
MacroGenics, Inc. said it entered an expanded royalty purchase agreement with Sagard in exchange for a capped royalty interest on future global net sales of ZYNYZ. The companies first agreed to buy and sell ZYNYZ royalties in June 2025; this amendment gives MacroGenics a $60 million upfront payment and the potential for an additional 2026 sales-based milestone payment of up to $20 million for the sale of its royalty rights.
Under the amended deal, all royalty rights will revert to MacroGenics once Sagard has received either 1.7 times its investment by September 30, 2032, or 2.0 times its investment at any time thereafter. MacroGenics also keeps other economic interests tied to ZYNYZ, including future development, regulatory and commercial milestone payments.
MacroGenics filed more details in a Current Report on Form 8-K with the U.S. Securities and Exchange Commission. ZYNYZ is marketed in the U.S. by Incyte.Read Announcement
- Drug:
- Zynyz
- Announced Date:
- March 6, 2026
- Indication:
- For Advanced Anal Cancer Patients in the United States
Announcement
Incyte announced that the European Commission (EC) has approved Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).
AI Summary
Incyte announced that the European Commission has approved Zynyz (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). This approval makes Zynyz the first systemic treatment option for adults with advanced SCAC in Europe.
The decision is based on data from the Phase 3 POD1UM-303 trial, which showed that adding Zynyz to carboplatin and paclitaxel significantly improved progression-free survival compared with chemotherapy alone in patients who had not received prior systemic therapy.
Zynyz is a PD‑1 immunotherapy, and this approval is the first time a PD‑1 inhibitor has been cleared in Europe in combination with platinum‑based chemotherapy for first‑line SCAC. The EC action expands treatment options for a rare cancer that has seen few advances in recent decades.
Read Announcement- 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.
Read Announcement
Ruxolitinib (Jakafi) FDA Regulatory Events
Ruxolitinib (Jakafi) is a drug developed by Incyte for the following indication: Steroid-refractory chronic Graft-Versus-Host Disease (GVHD).
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 (Jakafi)
- Announced Date:
- May 1, 2026
- Indication:
- Steroid-refractory chronic Graft-Versus-Host Disease (GVHD)
Announcement
Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy.
AI Summary
Incyte announced that the U.S. Food and Drug Administration has approved Jakafi XR™ (ruxolitinib) extended‑release tablets. The approval covers adults with intermediate‑ or high‑risk myelofibrosis (MF); adults with polycythemia vera (PV) who had an inadequate response to or are intolerant of hydroxyurea; and adults and children 12 years and older with steroid‑refractory acute graft‑versus‑host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy. Incyte says Jakafi XR provides a once‑daily option for appropriate patients, expanding treatment choice without changing Jakafi’s established role in practice.
Safety for Jakafi XR is supported by adequate studies of Jakafi in MF, PV, and acute and chronic GVHD. The company notes common adverse reactions were observed in those studies and highlights serious risks such as infections, worsening symptoms if treatment is stopped abruptly, blood clots, and potential increased risk of new cancers. It is not known if Jakafi XR is safe or effective in children for treatment of MF or PV, and patients should discuss benefits and risks with their healthcare provider.
Read Announcement
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:
- April 21, 2026
- Indication:
- In patients with relapsed or refractory follicular lymphoma (FL).
Announcement
Incyte announced that full results from the Phase 3 pivotal study evaluating tafasitamab (Monjuvi®/Minjuvi®) in first-line diffuse large b-cell lymphoma (DLBCL) will be featured as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29 – June 2, 2026, in Chicago.
AI Summary
Incyte announced that full results from the Phase 3 pivotal frontMIND study of tafasitamab (Monjuvi®/Minjuvi®) in first‑line diffuse large B‑cell lymphoma (DLBCL) will be featured as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, held May 29–June 2, 2026. The presentation is listed as Abstract #7000 in the Oral Abstract Session on Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia and is scheduled for May 30, 4:00–7:00 p.m. ET (3:00–6:00 p.m. CDT).
The frontMIND Phase 3 trial evaluated tafasitamab plus lenalidomide with R‑CHOP in patients with newly diagnosed DLBCL. Incyte says the full data support global regulatory submissions and could influence first‑line treatment options. The oral presentation will give clinicians and researchers a chance to see the detailed safety and efficacy findings and discuss their implications for patient care and future regulatory steps.
Read Announcement- 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.
Read Announcement
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 28, 2026
- Indication:
- AK1 inhibitor
Announcement
Incyte announced 54-week data evaluating the safety and efficacy of povorcitinib (INCB54707), an oral small-molecule highly-selective JAK1 inhibitor, from the pivotal Phase 3 STOP-HS clinical trial program in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS).
AI Summary
Incyte reported 54-week data from the pivotal Phase 3 STOP-HS program evaluating povorcitinib (INCB54707), an oral, highly selective JAK1 inhibitor, in adults (≥18 years) with moderate to severe hidradenitis suppurativa (HS). The analysis focused on safety and efficacy through one year of treatment.
After Week 12, participants entered a 42-week extension: those on 45 mg or 75 mg continued the same dose, and placebo patients were reassigned 1:1 to 45 mg or 75 mg. Across both STOP-HS studies, durable and clinically meaningful responses were seen through Week 54, with up to 71.4% achieving HiSCR50, up to 57% achieving HiSCR75, and up to 29% achieving HiSCR100.
By Week 54, many participants also reported meaningful quality-of-life gains: skin pain improvements (40.5–46.8%), less fatigue (49.0–58.0%), better skin condition–related QoL (59.4–64.7%), and improved HS-specific QoL (33.7–40.2%). Safety and tolerability were evaluated through Week 54.
Read Announcement- Drug:
- povorcitinib
- Announced Date:
- September 17, 2025
- Indication:
- AK1 inhibitor
Announcement
Incyte announced new 24-week interim data evaluating the safety and efficacy of povorcitinib (INCB54707), an oral small-molecule highly-selective JAK1 inhibitor, from the pivotal Phase 3 STOP-HS clinical trial program in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS).
AI Summary
Incyte announced new 24-week interim results from its pivotal Phase 3 STOP-HS1 and STOP-HS2 trials of povorcitinib (INCB54707), an oral JAK1 inhibitor, in adults with moderate to severe hidradenitis suppurativa (HS). The data are slated to support regulatory filings in Europe in 2025 and the U.S. in early 2026.
Across both studies, povorcitinib 45 mg and 75 mg once daily delivered clinically meaningful, statistically significant improvements through Week 24. Nearly 60% of efficacy-evaluable patients achieved HiSCR50 (≥50% reduction in abscess and nodule count). Higher response thresholds were also met: HiSCR75 by 31.0%–40.3%, HiSCR90 by 13.8%–27.7% and HiSCR100 by 9.2%–21.3% of treated patients.
Patients reported faster relief of skin pain, with benefits seen by Week 3 and maintained through Week 24. By the end of the study period, 62%–70% of patients experienced mild or no pain.
The safety profile remained consistent with earlier findings. Both doses were well tolerated, with no major cardiovascular events or deaths reported over 24 weeks.
Read Announcement- Drug:
- povorcitinib
- Announced Date:
- September 10, 2025
- Indication:
- AK1 inhibitor
Announcement
Incyte announced that it will present new data from its dermatology portfolio at the European Association of Dermatology and Venerology (EADV) 2025 Congress, held from September 17 – 20, in Paris.
AI Summary
Incyte announced it will present new dermatology data at the European Association of Dermatology and Venerology (EADV) 2025 Congress, Sept. 17–20 in Paris. Highlights include a late-breaking oral presentation of 24-week results from the Phase 3 STOP-HS trial of povorcitinib, an oral JAK1 inhibitor, in patients with moderate-to-severe hidradenitis suppurativa (HS). Additional presentations will cover safety and efficacy of ruxolitinib cream in prurigo nodularis, atopic dermatitis and vitiligo.
Pablo J. Cagnoni, M.D., said these data reinforce the potential of povorcitinib and ruxolitinib cream to provide new treatment options for challenging immune-mediated skin conditions. Incyte’s program at EADV features several late-breaking and poster sessions, showcasing progress across its dermatology portfolio and its commitment to patients with unmet needs.
Attendees can review numerous abstracts detailing Incyte’s ongoing research and see how these therapies may shape future standards of care in HS, atopic dermatitis, vitiligo and prurigo nodularis.
Read Announcement- 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.
Read Announcement
Baricitinib FDA Regulatory Events
Baricitinib is a drug developed by Incyte for the following indication: Moderate to severe Atopic Dermatitis (AD).
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:
- Baricitinib
- Announced Date:
- February 27, 2026
- Indication:
- Moderate to severe Atopic Dermatitis (AD)
Announcement
Eli Lilly and Company and Incyte announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Olumiant (baricitinib) for the treatment of adolescents (ages 12 to <18) with severe alopecia areata (AA).
AI Summary
Eli Lilly and Incyte said the European Medicines Agency’s CHMP has issued a positive opinion for Olumiant (baricitinib) to treat adolescents ages 12 to under 18 with severe alopecia areata (AA). The recommendation is based on Phase 3 BRAVE‑AA‑PEDS results showing 42% of treated patients achieved 80% or more scalp hair coverage at 36 weeks. Many participants also experienced eyebrow and eyelash regrowth, and treatment produced near‑complete scalp regrowth for a substantial share of patients.
BRAVE‑AA‑PEDS is the first and largest trial designed specifically for children and adolescents with severe AA, a disease that can have serious social and emotional effects. The safety profile in adolescents was consistent with that seen in pediatric trials for other conditions. The CHMP opinion is now referred to the European Commission for a final decision, expected within about one to two months, potentially expanding treatment options for young people with severe AA.
Read Announcement- Drug:
- Baricitinib
- Announced Date:
- October 24, 2025
- Indication:
- Moderate to severe Atopic Dermatitis (AD)
Announcement
New results from Eli Lilly and Company ) showed once-daily, oral baricitinib 4 mg helped the majority of adolescent patients (ages 12 to <18) with severe alopecia areata (AA) achieve successful hair regrowth on the scalp, eyebrows and eyelashes at one year.
AI Summary
The BRAVE-AA-PEDS trial is the first and largest study specifically designed for adolescents (ages 12 to <18) with severe alopecia areata. At the start, participants had an average of 89% scalp hair loss and many had minimal or no eyebrow and eyelash hair.
After one year of once-daily, oral baricitinib 4 mg, 71% of adolescents with severe disease achieved successful scalp hair regrowth (≥80% coverage), and 41.2% reached near-complete regrowth (≥90% coverage). Significant eyebrow improvements were seen in 64.8% of patients, with 63.3% achieving meaningful eyelash regrowth. Hair coverage continued to improve throughout the 52-week study.
The safety profile in adolescents was consistent with adult data, with common side effects including acne and upper respiratory infections. Lilly plans to submit the BRAVE-AA-PEDS results to global regulators for a possible label update for baricitinib (Olumiant).
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Tafasitamab FDA Regulatory Events
Tafasitamab is a drug developed by Incyte for the following indication: in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.
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
- Announced Date:
- January 5, 2026
- Indication:
- in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.
Announcement
Incyte announced positive topline results from the pivotal Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®/Minjuvi®), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared to R-CHOP alone as a first-line treatment for adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL) with an International Prognostic Index (IPI) score of three to five (3-5) for patients >60 years of age, or age-adjusted IPI (aaIPI) of two to three (2-3) for patients ≤60 years of age.
AI Summary
Incyte announced positive topline results from the pivotal Phase 3 frontMIND trial testing tafasitamab — a humanized Fc‑modified CD19 monoclonal antibody — with lenalidomide added to R‑CHOP versus R‑CHOP alone as first‑line treatment for adults with newly diagnosed diffuse large B‑cell lymphoma (DLBCL) at higher risk (IPI 3–5 for patients over 60, aaIPI 2–3 for patients 60 or younger). The randomized, double‑blind, placebo‑controlled global study enrolled about 900 patients.
The trial met its primary endpoint of investigator‑assessed progression‑free survival per Lugano 2014 criteria (HR 0.75; 95% CI 0.59–0.96; p=0.019) and also met the key secondary endpoint of event‑free survival. No new safety signals were observed. Incyte said the combination could offer a more effective option and increase the chance of cure for high‑risk newly diagnosed patients.
Based on these results, Incyte plans to file a supplemental Biologics License Application (sBLA) for tafasitamab plus lenalidomide with R‑CHOP in first‑line DLBCL in the first half of 2026, and will submit frontMIND data for presentation at an upcoming scientific meeting.
Read Announcement- Drug:
- tafasitamab
- Announced Date:
- November 17, 2025
- Indication:
- in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.
Announcement
Incyte announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.
AI Summary
Incyte announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of Minjuvi® (tafasitamab) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL) Grade 1–3a after at least one systemic therapy. The opinion is under review by the European Commission. If approved, the regimen would offer an important CD19- and CD20-dual-targeted immunotherapy option in Europe for second-line treatment.
The CHMP opinion was based on the Phase 3 inMIND trial of 548 FL patients, which showed improved progression-free survival: median PFS 22.4 months with Minjuvi plus lenalidomide and rituximab versus 13.9 months with placebo plus lenalidomide and rituximab (HR 0.43; P<0.0001). Safety was described as manageable; common adverse events included infections, diarrhea, rash and fatigue. The therapy could address a key unmet need for patients who relapse after initial treatment.
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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:
- December 22, 2025
- Indication:
- Metastatic squamous cell carcinoma of the anal canal
Announcement
Incyte Biosciences Japan G.K announced the Japan Ministry of Health, Labour and Welfare (MHLW) approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC)..
AI Summary
Incyte Biosciences Japan G.K. announced that Japan’s Ministry of Health, Labour and Welfare approved Zynyz® (retifanlimab) combined with carboplatin and paclitaxel as a first-line treatment for adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) who have not received prior systemic chemotherapy. This marks the first regulatory approval of Zynyz in Japan and provides a new treatment option for a rare, serious cancer.
The approval was based on the Phase 3 POD1UM-303/InterAACT2 trial, published in The Lancet, which showed a statistically significant 37% reduction in the risk of disease progression or death (P=0.0006). Median progression-free survival was 9.3 months with retifanlimab plus chemotherapy versus 7.4 months with placebo plus chemotherapy.
No new safety concerns were identified overall, but 47% of patients on the combination experienced serious adverse reactions. The most frequent serious events (≥2%) were sepsis, pulmonary embolism, diarrhea and vomiting. In Japan, SCAC represents about 16–24% of anal canal cancers.
Read Announcement- 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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INCA33890 FDA Regulatory Events
INCA33890 is a drug developed by Incyte for the following indication: treatment in microsatellite stable (MSS) colorectal cancer.
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:
- INCA33890
- Announced Date:
- October 19, 2025
- Indication:
- treatment in microsatellite stable (MSS) colorectal cancer
Announcement
Incyte announced the first clinical data evaluating its TGFβR2×PD-1 bispecific antibody (INCA33890) for patients with microsatellite stable (MSS) colorectal cancer; and its potent, selective and orally bioavailable KRAS G12D inhibitor (INCB161734) for patients with KRAS G12D mutations, specifically pancreatic ductal adenocarcinoma (PDAC).
AI Summary
Incyte presented early Phase 1 data on INCA33890, a TGFβR2×PD-1 bispecific antibody, in patients with microsatellite stable (MSS) colorectal cancer. Among 105 heavily pretreated patients, 15.2% achieved an objective response with a median therapy duration of 7.3 months. The safety profile was manageable, with fatigue (13.8%), itching (8.8%) and infusion-related reactions (8.4%) as the most common side effects. Deep tumor responses were seen in both liver-metastasis and non-metastasis groups.
Incyte plans to start a registrational program for INCA33890 in MSS colorectal cancer in 2026 and is testing it in combination with standard therapies.
They also reported on INCB161734, a potent, selective, oral KRAS G12D inhibitor for pancreatic ductal adenocarcinoma. In 54 patients at 600 mg and 1,200 mg daily, objective response rates were 20% and 34%, with disease control rates of 64% and 86%. No dose-limiting toxicities emerged, and most side effects (nausea, diarrhea, vomiting, fatigue) were mild. These maturing data support further clinical development and upcoming regulatory discussions.
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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:
- September 28, 2025
- Indication:
- Atopic dermatitis (AD), a type of eczema
Announcement
China Medical System Holdings Limited ("CMS") is pleased to announce that its subsidiaries, Dermavon Holdings Limited ("Dermavon", an innovative pharmaceutical company specialized in skin health which is applying for a separate listing on the Main Board of The Stock Exchange of Hong Kong Limited, please refer to the announcement published by CMS on 22 April 2025 for details) together with its subsidiaries, obtained positive results from the phase 3 clinical trial (the "Trial") of ruxolitinib cream (the "Product") in patients with mild to moderate atopic dermatitis (AD) in China.
AI Summary
China Medical System Holdings Limited (CMS) reports that Dermavon Holdings Limited and its subsidiaries achieved positive results in a phase 3 trial of ruxolitinib cream for mild to moderate atopic dermatitis in China. The randomized, double-blind, placebo-controlled study enrolled 192 patients across multiple centers, led by Shanghai Dermatology Hospital.
At week 8, 63.0% of patients using ruxolitinib cream reached an Investigator’s Global Assessment score of 0 or 1 with at least two grades of improvement, compared with 9.2% for placebo (P<0.001). For the key secondary endpoint, 78.0% of treated patients achieved a 75% improvement in the Eczema Area and Severity Index score, versus 15.4% for placebo (P<0.001).
The cream was generally safe and well tolerated, with mostly mild or moderate treatment-emergent adverse events and no discontinuations due to safety issues. CMS is advancing the new drug application for ruxolitinib cream in China.
Dermavon is applying for a separate listing on the Main Board of the Hong Kong Stock Exchange; see CMS’s 22 April 2025 announcement for details.
Read Announcement- 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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Niktimvo FDA Regulatory 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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Tafasitamab + (Lenalidomide and Rituximab) FDA Regulatory 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.
Read Announcement
MRGPRX2 FDA Regulatory 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.
Read Announcement
