Incyte's Topical JAK Inhibitor Under Priority FDA Review For Depigmented Skin Disorder


20-Year Pro Trader Reveals His "MoneyLine"

Ditch your indicators and use the "MoneyLine." A simple line tells you when to buy and sell without the guesswork. It’s a line on a chart that’s helped Nic Chahine win 83% of his options buys. Here's how he does it.


The FDA has accepted for review Incyte Corporation's (NASDAQ:INCY) supplemental marketing application seeking approval for ruxolitinib cream 1.5% (Opzelura), a topical JAK inhibitor for vitiligo. 

  • Under the Priority Review, the application covers adolescents and adults (over 12 years) with vitiligo, a chronic autoimmune disease characterized by skin depigmentation.
  • The agency's Prescription Drug User Fee Act target action date is April 18, 2022.
  • Related content: Benzinga's Full FDA Calendar.
  • The submission is supported by Phase 3 TRuE-V trial data evaluating the safety and efficacy of ruxolitinib cream in more than 600 people. 
  • The data showed that at Week 24, 29.9% of patients applying ruxolitinib cream achieved over 75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint.
  • Related: Back To Back FDA Approval For Incyte - This Time For Jakafi In GVHD.
  • Price Action: INCY shares are up 1.15% at $68.59 during the premarket session on the last check Wednesday.

20-Year Pro Trader Reveals His "MoneyLine"

Ditch your indicators and use the "MoneyLine." A simple line tells you when to buy and sell without the guesswork. It’s a line on a chart that’s helped Nic Chahine win 83% of his options buys. Here's how he does it.


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Posted In: BiotechNewsHealth CareFDAGeneralBriefsVitiligo