Incyte(US:INCY) Businesswire·2026-03-28 19:00Core Insights - Incyte announced positive 54-week data for povorcitinib, a JAK1 inhibitor, in treating moderate to severe hidradenitis suppurativa (HS) at the 2026 AAD Annual Meeting, highlighting its potential as a first oral treatment option for HS [1][11]. Group 1: Clinical Efficacy - The 54-week results from the STOP-HS program showed that up to 71.4% of patients achieved HiSCR50, with 57% achieving HiSCR75 and 29% achieving HiSCR100, indicating substantial and durable clinical efficacy [4][6]. - Clinically meaningful improvements in quality-of-life measures, including skin pain and fatigue, were observed at Week 54, with 40.5-46.8% of participants reporting improvements in skin pain and 49.0-58.0% in fatigue [8][9]. - Full resolution of inflammatory lesions was achieved in up to 20% of patients, with consistent reductions in abscesses, inflammatory nodules, and draining tunnels across both doses [7][4]. Group 2: Safety Profile - The overall safety profile of povorcitinib through 54 weeks was consistent with previously reported data, with treatment-emergent adverse events (TEAEs) occurring in 76.2% to 83.4% of patients, primarily mild or moderate [9][10]. - Serious TEAEs were low, ranging from 3.7% to 6.4%, and grade >3 TEAEs were reported at 5.4% to 8.0%, indicating a manageable safety profile [9][10]. - Rates of adverse events of special interest, including serious infections and malignancies, were low (<2.3%), supporting the safety of povorcitinib [10]. Group 3: Regulatory and Market Implications - The STOP-HS data support the submission of a New Drug Application (NDA) and Marketing Authorization Application (MAA) for povorcitinib, which are currently under review by the U.S. FDA and European Medicines Agency [11][18]. - Incyte aims to advance regulatory applications in the U.S. and Europe, indicating a strategic focus on expanding its market presence in the treatment of HS [3][11].