Incyte

5 approvals or clearances and 0 recalls recorded by the FDA for this company and its listed subsidiaries.

Approvals and clearances

• Sep 25AtebriozDrug approval · New drug application approved. Active ingredient: Zilurgisertib
• May 18ZynyzDrug approval · New use approved (efficacy supplement). Active ingredient: Retifanlimab-Dlwr
• May 1Jakafi XRDrug approval · New drug application approved. Active ingredient: Ruxolitinib Phosphate
• Mar 30ZynyzDrug approval · New use approved (efficacy supplement). Active ingredient: Retifanlimab-Dlwr
• Dec 17ZynyzDrug approval · New use approved (efficacy supplement). Active ingredient: Retifanlimab-Dlwr

From openFDA: Drugs@FDA (new applications and new uses), device 510(k) and PMA decisions, and FDA enforcement reports. Class I recalls are the most serious, Class III the least. Most recalls are started by the company itself. Labeling and manufacturing changes are not listed.

17 certified in FY2026 Q3, vs 21 a year earlier. 17 positions in total, median offered wage $150K a year.

Labor condition applications for H-1B workers certified by the Department of Labor, counted by decision date (FY2026 Q3: Apr 1, 2026 to Jun 30, 2026, the latest quarter published). A certified application is a step before a visa petition, not a hire or a visa, and one application can cover several positions. Matched by employer ID number or name.

• Felix J. Baker

  Schedule 13D: may seek to influence the company · filed May 11, 2026 · 31.2M shares

  15.6%

• BlackRock, Inc.

  Schedule 13G: passive · filed Oct 17, 2025 · 15.2M shares

  7.8%

• Vanguard Capital Management

  Schedule 13G: passive · filed Apr 30, 2026 · 12.6M shares

  6.32%

• Dodge & Cox

  Schedule 13G: passive · filed May 14, 2026 · 12.3M shares

  6.2%

• STATE STREET CORPORATION

  Schedule 13G: passive · filed Nov 10, 2025 · 9.68M shares

  5%

Anyone owning more than 5% must file within days. Structured filings exist since December 2024, so older stakes that were never amended may be missing.

23 active phase 3 trials and 17 active phase 2 trials led by this company, mostly in chronic graft-versus-host-disease, nonsegmental vitiligo, hidradenitis suppurativa (hs). The ones with the nearest registered primary completion date still ahead:

• Oct 2026Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)Phase 3Active, not recruitingHidradenitis Suppurativa
• Oct 2026Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)Phase 3Active, not recruitingHidradenitis Suppurativa
• Oct 2026A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)Phase 3Active, not recruitingPrurigo Nodularis
• Oct 2026A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)Phase 3Active, not recruitingPrurigo Nodularis
• Nov 2026Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)Phase 2Active, not recruitingB-Cell Malignancies
• Nov 2026A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe AsthmaPhase 2Active, not recruitingModerate to Severe Asthma

11 trials have a registered primary completion date that has already passed. That usually means the data are being analysed, or the entry has not been updated.

Source: ClinicalTrials.gov, studies whose lead sponsor is the company or a listed subsidiary. “Primary completion” is the sponsor's own registry date for the last main data collection. It is not an approval date, it says nothing about the result, and it is often revised.