Analyst Writes Incyte's Opzelura Provides Deepening, Relapse Prevention; Povo Data Intriguing In Depigmented Skin Disorder

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  • Incyte Corporation INCY announced new data from a Phase 2b trial of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo. 
  • Results from the study demonstrate that treatment with oral povorcitinib was associated with substantial total body repigmentation, as measured by total Vitiligo Area Scoring Index (T-VASI) scores. 
  • The study met its primary endpoint, and patients receiving povorcitinib experienced statistically superior improvements in T-VASI at Week 24 compared to placebo (povorcitinib 15 mg, –19.1%; 45 mg, –17.8%; 75 mg, –15.7% vs. placebo, +2.3%; least squares mean [LSM] difference). 
  • William Blair writes that data for povorcitinib showed clear efficacy. Still, additional follow-ups are needed to determine a better go-forward dose and strategy to strike the best risk/reward profile.
  • Incyte also announced new 104-week results from the pivotal Phase 3 TRuE-V trial evaluating Opzelura (ruxolitinib) cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo.
  • Many patients who achieved a high level of facial repigmentation could maintain a durable response for one year after discontinuing Opzelura treatment.
  • In patients who did not achieve near complete facial repigmentation at Week 52 and continued treatment with Opzelura, facial and total body repigmentation improvements were observed through Week 104.
  • The analyst writes that the American Academy of Dermatology meeting updates are unlikely to shift the near-term investor focus away from commercial execution on Opzelura.
  • William Blair reiterated its Outperform rating on the stock.
  • Price Action: INCY shares traded higher by 0.57% at $74.04 on the last check Monday.
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