After a year, Incyte’s oral HS drug showed durable gains in Phase 3 Up to 57% of patients hit HiSCR75 and 29% reached HiSCR100 at Week 54, with safety in line with prior data as U.S. and EU reviews continue.

#INCY Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting

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Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting Incyte (Nasdaq:INCY) announced it will present late-breaking 54-week data for povorcitinib in hidradenitis suppurativa from the Phase 3 STOP-HS1 and STOP-HS2 trials at the AAD Annual Meeting, March 27–31, 2026, in Denver. Multiple ePosters will feature ruxolitinib cream across atopic dermatitis and vitiligo.The company said the 54-week results provide longer-term evidence on safety and efficacy and reinforce growth potential for its Inflammation and Autoimmunity franchise. Presentations include a late-breaking oral session on March 28, 2026.

#INCY Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting

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Incyte Announces the European Commission Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC) Incyte today announced that the European Commission has approved Zynyz ® in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal. “The EC approval of Zynyz marks an important step forward for patients with advanced SCAC, a...

#INCY Incyte Announces the European Commission Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)

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Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata Lilly has also submitted Olumiant in the U.S. for approval to treat severe AA in adolescents, with a decision expected in the second half of 2026. INDIANAPOLIS, Feb. 27, 2026/ PRNewswire/-- Eli Lilly and Company and Incyte announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Olumiant...

#LLY #INCY Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata

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Incyte Announces Positive Topline Results from Pivotal Study of Tafasitamab (Monjuvi®/Minjuvi®) as a First-line Treatment for Diffuse Large B-Cell Lymphoma Incyte (NASDAQ:INCY) reported positive topline results from the pivotal Phase 3 frontMIND trial of tafasitamab (Monjuvi/Minjuvi) plus lenalidomide with R-CHOP versus R-CHOP alone as first-line treatment for newly diagnosed diffuse large B-cell lymphoma (DLBCL).The trial met its primary endpoint of progression-free survival (PFS) by investigator assessment (Hazard Ratio 0.75 [0.59,0.96]; p=0.019) and met the key secondary endpoint of event-free survival (EFS). No new safety signals were observed. Incyte plans to file a sBLA in H1 2026 and will submit frontMIND data for presentation at an upcoming scientific meeting.

#INCY Incyte Announces Positive Topline Results from Pivotal Study of Tafasitamab (Monjuvi®/Minjuvi®) as a First-line Treatment for Diffuse Large B-Cell Lymphoma

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Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Rituximab and Lenalidomide for the Treatment of Relapsed or Refractory Follicular Lymphoma Incyte (NASDAQ:INCY) announced Japan MHLW approval of Minjuvi (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL) on December 22, 2025.The approval is based on the Phase 3 inMIND trial (654 patients) where the Minjuvi combination achieved a median progression-free survival (PFS) of 22.4 months vs 13.9 months for control, hazard ratio 0.43 (p<0.0001). Independent Review Committee assessments showed median PFS not reached in the Minjuvi arm versus 16.0 months in placebo. Common adverse reactions included respiratory infections, diarrhea and fatigue. This is Minjuvi's first regulatory approval in Japan.

#INCY Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Rituximab and Lenalidomide for the Treatment of Relapsed or Refractory Follicular Lymphoma

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Incyte Japan Announces Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Anal Cancer Incyte (NASDAQ: INCY) announced that Japan Ministry of Health, Labour and Welfare approved Zynyz® (retifanlimab) plus carboplatin and paclitaxel for first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC) on December 22, 2025.The approval is based on Phase 3 POD1UM-303/InterAACT2 results showing a 37% reduction in risk of progression or death (P=0.0006) and median progression-free survival of 9.3 months vs 7.4 months for placebo plus chemotherapy. No new safety concerns were identified; serious adverse reactions occurred in 47% of patients receiving Zynyz combination. This is Zynyz’s first approval in Japan and follows the FDA approval in May 2025; an EMA Type II variation MAA is pending for advanced SCAC.

#INCY Incyte Japan Announces Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Anal Cancer

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Incyte Announces New Positive Data for INCA033989, its First-In-Class mutCALR-Targeted Monoclonal Antibody, in Patients with Myelofibrosis Presented at ASH 2025 Incyte (NASDAQ:INCY) reported Phase 1 data for INCA033989, a mutCALR-targeted monoclonal antibody, showing rapid spleen-volume and symptom reductions and anemia improvements in myelofibrosis (data cut-off Sept 25, 2025). As monotherapy (n=36 evaluable at Week 24) SVR25 was 41.7% and SVR35 33.3%; higher responses were seen in JAK‑naïve patients. Anemia response occurred in 56% (14/25) with 40% major responses. Most patients showed reductions in mutCALR VAF and bone marrow mutCALR+ progenitors. No dose‑limiting toxicities; MTD not reached. Registrational program planned for 2026.

#INCY Incyte Announces New Positive Data for INCA033989, its First-In-Class mutCALR-Targeted Monoclonal Antibody, in Patients with Myelofibrosis Presented at ASH 2025

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Incyte’s First-in-Class mutCALR-Targeted Monoclonal Antibody, INCA033989, Granted Breakthrough Therapy Designation by U.S. FDA Incyte today announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to INCA033989, a first-in-class mutant calreticulin- targeted monoclonal antibody, for the treatment of patients with essential thrombocythemia harboring a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive...

#INCY Incyte’s First-in-Class mutCALR-Targeted Monoclonal Antibody, INCA033989, Granted Breakthrough Therapy Designation by U.S. FDA

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Incyte Announces Positive CHMP Opinion for Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma (FL) Pending the European Commission decision, Minjuvi ® in combination with rituximab and lenalidomide will represent an important new therapeutic option from second line for patients with follicular lymphoma in Europe In Western countries, relapsed or refractory FL affects 2-4 out of every 100,000 people 1 The positive Committee for Medicinal Products...

#INCY Incyte Announces Positive CHMP Opinion for Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma (FL)

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Incyte Announces More than 50 Abstracts Accepted for Presentation at the 2025 ASH Annual Meeting Incyte today announced that data from key programs in its oncology portfolio will be presented in both oral and poster sessions at the 2025 American Society of Hematology Annual Meeting, to be held December 6– 9, 2025, in Orlando. "This year’ s Incyte presentations highlight the potential of our portfolio to transform the treatment of blood cancers,...

#INCY Incyte Announces More than 50 Abstracts Accepted for Presentation at the 2025 ASH Annual Meeting

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Incyte Reports Third Quarter 2025 Financial Results and Provides Business Updates Incyte (Nasdaq:INCY) reported third-quarter 2025 results with $1.37 billion total revenues, up 20% YoY, and $1.15 billion net product revenues, up 19% YoY. Jakafi net product revenue was $791 million (+7% YoY) and Opzelura net product revenue was $188 million (+35% YoY). The company raised full‑year 2025 net product revenue guidance to $4.23–$4.32 billion and raised Jakafi guidance to $3.050–$3.075 billion while maintaining Opzelura guidance of $630–$670 million. GAAP diluted EPS was $2.11 for the quarter and cash plus marketable securities totaled $2.9 billion as of September 30, 2025.Business updates include regulatory filings and anticipated data readouts for ruxolitinib XR, INCA033989, INCA33890, INCB161734 and multiple late‑stage studies; some programs were paused as part of pipeline prioritization.

#INCY Incyte Reports Third Quarter 2025 Financial Results and Provides Business Updates

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Incyte and Enable Injections Announce Strategic Partnership for enFuse® On-Body Delivery System Incyte (NASDAQ:INCY) and Enable Injections announced a strategic partnership on October 27, 2025 to develop and commercialize Incyte’s investigational mutCALR monoclonal antibody (INCA033989) using Enable’s enFuse® On-Body Delivery System.Under the agreement Incyte obtains a worldwide, exclusive license to use enFuse with INCA033989 in essential thrombocythemia (ET) and myelofibrosis (MF), with potential expansion to other assets and indications. Financial terms include an upfront technology access fee, potential R&D and commercial milestones, and a transfer price for clinical and commercial supply of enFuse devices. enFuse is designed to deliver large-volume subcutaneous doses and enable flexible site-of-care, including at-home self-administration.

#INCY Incyte and Enable Injections Announce Strategic Partnership for enFuse® On-Body Delivery System

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Incyte Announces New Data from Phase 3b TRuE-AD4 Trial of Opzelura® (Ruxolitinib Cream) in Adults with Moderate Atopic Dermatitis These data will be presented during the Systemic and New Therapies for Atopic Dermatitis session on Sunday, October 26 at 10:55 a.m. AEDT at the 15th Georg Rajka International Symposium on Atopic Dermatitis, held from October 24– 26, 2025, in Melbourne. “The TRuE-AD4 data further reinforce the safety and efficacy profile of Opzelura and its ability to control...

#INCY Incyte Announces New Data from Phase 3b TRuE-AD4 Trial of Opzelura® (Ruxolitinib Cream) in Adults with Moderate Atopic Dermatitis

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Lilly's baricitinib delivered near-complete scalp hair regrowth at one year for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS trial This trial is the first and largest study specifically designed to evaluate children and adolescents with severe alopecia areata, a population often underrepresented in clinical trials. New data show 71% of adolescents with severe disease treated with baricitinib 4 mg achieved successful scalp hair regrowth at one year, with continuous improvements...

#LLY #INCY Lilly's baricitinib delivered near-complete scalp hair regrowth at one year for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS trial

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Incyte Announces Phase 1 Results for its TGFβR2×PD-1 Bispecific Antibody in Advanced Colorectal Cancer and KRAS G12D Inhibitor in Advanced Pancreatic Ductal Adenocarcinoma Incyte announced the first clinical data evaluating its TGFβR2× PD-1 bispecific antibody for patients with microsatellite stable colorectal cancer; and its potent, selective and orally bioavailable KRAS G12D inhibitor for patients with KRAS G12D mutations, specifically pancreatic ductal adenocarcinoma. The data were featured in two oral sessions at...

#INCY Incyte Announces Phase 1 Results for its TGFβR2×PD-1 Bispecific Antibody in Advanced Colorectal Cancer and KRAS G12D Inhibitor in Advanced Pancreatic Ductal Adenocarcinoma

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Data from Incyte’s TGFβR2×PD-1 Bispecific Antibody and KRAS G12D Inhibitor to be Presented at the European Society of Medical Oncology (ESMO) Congress 2025 Incyte (Nasdaq:INCY) announced that Phase 1 proof-of-concept data for two investigational therapies—INCA33890 (TGFβR2×PD-1 bispecific) and INCB161734 (oral KRAS G12D inhibitor)—will be presented as oral presentations at the ESMO Congress 2025 in Berlin.INCA33890 is scheduled for a mini oral session on October 17, 2025, 8:00–9:30 a.m. ET (Abstract #1522). INCB161734 is scheduled for a proffered paper session on October 19, 2025, 8:45–10:20 a.m. ET (Abstract #916O). An in-person analyst and investor event discussing these data will be held on October 19, 2025, 1:30–3:00 p.m. ET, with a webcast available via Incyte’s Events and Presentations page and replay for 30 days.

#INCY Data from Incyte’s TGFβR2×PD-1 Bispecific Antibody and KRAS G12D Inhibitor to be Presented at the European Society of Medical Oncology (ESMO) Congress 2025

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Incyte Corporation (NASDAQ:INCY) Overview: Strategic Leadership and Market Performance

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Incyte Announces Additional FDA Approval of Opzelura® (Ruxolitinib) Cream in Children Ages 2-11 with Atopic Dermatitis Incyte (NASDAQ:INCY) has received FDA approval for Opzelura® (ruxolitinib) cream 1.5% to treat mild to moderate atopic dermatitis in non-immunocompromised children aged 2-11 years. This marks Opzelura's third FDA approval, making it the first topical JAK inhibitor approved for pediatric atopic dermatitis in the U.S.The approval is based on the Phase 3 TRuE-AD3 trial, which demonstrated significant efficacy in achieving Investigator's Global Assessment-treatment success and 75% improvement in the Eczema Area and Severity Index. The treatment showed a consistent safety profile with no new concerns identified. This expansion addresses an estimated 2-3 million patients aged 2-11 in the U.S. affected by atopic dermatitis.

#INCY Incyte Announces Additional FDA Approval of Opzelura® (Ruxolitinib) Cream in Children Ages 2-11 with Atopic Dermatitis

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Incyte Earnings Report: Revenue Surges 16% to $1.2B, Two New Drug Approvals Boost Growth Outlook Jakafi sales reach $764M (+8%), Opzelura grows 35% to $164M. FDA approves Zynyz and Monjuvi for new indications. See full pipeline updates.

#INCY Incyte Reports 2025 Second Quarter Financial Results and Provides Updates on Key Clinical Programs

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Update on FDA Review of Ruxolitinib Cream (Opzelura®) for Children Ages 2-11 with Atopic Dermatitis Incyte (INCY) announced that the FDA has extended the review period for ruxolitinib cream (Opzelura) for treating atopic dermatitis in children aged 2-11 years. The PDUFA date is pushed back by 3 months to September 19, 2025, allowing FDA to review additional CMC data for the 0.75% strength formulation. The sNDA submission was supported by Phase 3 TRuE-AD3 study results, which met its primary endpoint with significantly more patients achieving IGA-TS compared to vehicle control. The study also met its secondary endpoint with patients showing EASI75 improvement at Week 8. The safety profile remained consistent with previous data, showing only mild application site pain in 2.7% of treated patients, with no serious adverse events reported.

#INCY Update on FDA Review of Ruxolitinib Cream (Opzelura®) for Children Ages 2-11 with Atopic Dermatitis

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Incyte Announces FDA Approval of Monjuvi® (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma The FDA has approved Incyte's Monjuvi (tafasitamab-cxix) in combination with rituximab and lenalidomide for treating adult patients with relapsed or refractory follicular lymphoma (FL). This marks Monjuvi's second FDA approval, following its 2020 approval for DLBCL treatment. The Phase 3 inMIND trial demonstrated significant improvement in progression-free survival, with patients receiving Monjuvi achieving 22.4 months median PFS compared to 13.9 months in the control arm. The trial showed 27.5% of Monjuvi patients experienced events versus 47.6% in the control group. This approval represents the first FDA-approved CD19- and CD20-targeted immunotherapy combination for FL patients. The safety profile showed serious adverse reactions in 33% of patients, with respiratory tract infections and decreased neutrophils among the most common side effects.

#INCY Incyte Announces FDA Approval of Monjuvi® (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma

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Positive Late-Breaking Data for Incyte’s First-in-Class mutCALR-targeted therapy INCA033989 in Essential Thrombocythemia Presented at EHA2025 Incyte announced groundbreaking clinical data for INCA033989, their first-in-class mutCALR-targeted monoclonal antibody therapy for essential thrombocythemia (ET). The late-breaking data presented at EHA2025 showed remarkable efficacy, with 86% of patients receiving doses ≥400mg achieving complete or partial hematologic response, and 82% reaching complete response. The drug demonstrated disease-modifying potential by selectively targeting and reducing mutCALR cells while promoting healthy blood cell production. In the study of 49 patients, 89% showed reduced mutCALR variant allele frequency. Safety profile was favorable with no dose-limiting toxicities, and 98% of patients maintained treatment. Most common side effects were mild, including fatigue (26.5%) and upper respiratory infections (20.4%). The company plans to initiate Phase 3 trials by early 2026 following regulatory discussions.

#INCY Positive Late-Breaking Data for Incyte’s First-in-Class mutCALR-targeted therapy INCA033989 in Essential Thrombocythemia Presented at EHA2025

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Phase 3 Data for Incyte’s Retifanlimab (Zynyz®) in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Published in The Lancet Incyte (INCY) announced the publication of Phase 3 POD1UM-303/InterAACT 2 trial results for Zynyz® (retifanlimab-dlwr) in The Lancet. The trial demonstrated significant benefits when combining retifanlimab with carboplatin-paclitaxel chemotherapy for treating advanced squamous cell carcinoma of the anal canal (SCAC). The study showed a 37% reduction in progression/death risk, with median progression-free survival of 9.3 months versus 7.4 months in the placebo group. Overall response rate improved to 55.8% with retifanlimab versus 44.2% with placebo. In May 2025, the FDA approved Zynyz® both in combination with chemotherapy for first-line treatment and as a single agent for advanced SCAC patients. Applications are under review by EMA and PMDA.

#INCY Phase 3 Data for Incyte’s Retifanlimab (Zynyz®) in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Published in The Lancet

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Specialised Therapeutics Expands Partnership with Incyte to Include Two Additional Therapies for Hard-to-Treat Conditions Specialised Therapeutics (ST) has expanded its partnership with Incyte to distribute two additional oncology therapies - axatilimab (Niktimvo) and retifanlimab (Zynyz) - in Australia, New Zealand, and Singapore. These medicines join the existing portfolio of Minjuvi and Pemazyre. Axatilimab, approved by FDA in August 2024, treats chronic graft-versus-host disease in patients who've had at least two prior treatments. Retifanlimab is approved for treating squamous cell carcinoma of the anal canal and Merkel cell carcinoma, with Australia having the highest MCC incidence globally. Under the agreement, Incyte will handle development and manufacturing, while ST will manage regulatory affairs, distribution, and local marketing. ST plans to submit both drugs for regulatory and reimbursement approval in 2025.

#INCY Specialised Therapeutics Expands Partnership with Incyte to Include Two Additional Therapies for Hard-to-Treat Conditions

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Incyte Announces Multiple Presentations, Including New Late-Breaking Data for its mutCALR-Directed Monoclonal Antibody (INCA033989), Accepted for Presentation at EHA 2025 Incyte (INCY) announced multiple presentations at the 2025 European Hematology Association Congress in Milan, featuring late-breaking data for INCA033989, their novel mutCALR-directed monoclonal antibody for essential thrombocythemia (ET). The presentations include data from their hematology/oncology portfolio, with a key focus on INCA033989's potential as a disease-modifying treatment for myeloproliferative neoplasms. The congress will feature presentations on various programs including INCA035784, ruxolitinib, tafasitamab, axatilimab, INCB057643, and ponatinib. Incyte will host an analyst and investor event on June 15, 2025, from 6:00-7:30 a.m. EDT to discuss the mutCALR data.

#INCY Incyte Announces Multiple Presentations, Including New Late-Breaking Data for its mutCALR-Directed Monoclonal Antibody (INCA033989), Accepted for Presentation at EHA 2025

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