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Incyte (INCY) Announces Positive Results From Vitiligo Study

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Incyte (INCY - Free Report) announced positive top-line results from its late-stage program on ruxolitinib cream, an investigational, nonsteroidal, anti-inflammatory, JAK inhibitor, topical therapy.

The phase III TRuE-V clinical trial program is evaluating the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age ≥12 years) with vitiligo.

Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes.

Both studies, TRuE-V1 and TRuE-V2, met the primary endpoint as results showed that significantly more patients treated with ruxolitinib cream 1.5% twice daily (BID) achieved a ≥75% improvement from baseline in the facial vitiligo area scoring index (F-VASI75) compared to patients treated with a vehicle control at week 24.

Moreover, the overall efficacy and safety profile of ruxolitinib cream is consistent with the previously reported phase II data and no new safety signals were observed.  

These encouraging results confirm the potential of ruxolitinib cream in the treatment of vitiligo, for which there are no approved therapies yet.

Hence, the long-term efficacy and safety portions of both studies will continue as planned.

Consequently, based on these positive results, Incyte plans to submit marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo (age ≥12 years) to the FDA and the European Medicines Agency (EMA) in the second half of 2021.

A new drug application (NDA) for ruxolitinib cream for the treatment of adolescents and adults (age ≥12 years) with atopic dermatitis is currently under review in the United States with a target action date of Jun 21, 2021.

Shares of the company have lost 5.4% in the year so far compared with the industry’s 5.6% decline.

 

Incyte’s performance in the first quarter was unimpressive, as lead drug Jakafi’s net sales were affected by typical seasonal effects and softer patient demand growth due to the ongoing pandemic. The company has a collaboration agreement with Novartis (NVS - Free Report) .

Nevertheless, label expansion into additional indications should boost performance, going forward. The supplemental new drug application (sNDA) seeking approval of Jakafi for the treatment of steroid-refractory chronic GVHD has been accepted for Priority Review by the FDA. The agency has set a target action date of Jun 22, 2021.

Moreover, the uptake of Monjuvi with MorphoSys (MOR - Free Report) is encouraging and should boost sales.

Incyte currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Repligen Corp. (RGEN - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Repligen’s earnings estimates for 2021 have increased to $1.91 from $1.66 in the past 60 days.

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