FDA Grants Incyte Priority Review for Ruxolitinib Cream


This article was originally published on TipRanks.com

Biopharmaceutical company Incyte (NASDAQ: INCY) announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the supplemental New Drug Application (sNDA) for its ruxolitinib cream (Opzelura). The ruxolitinib cream is a topical JAK inhibitor designed to treat adolescents and adults (aged 12 years or older) with vitiligo.

The FDA grants Priority Review to medicines that potentially provide advanced treatments in the absence of alternatives. The Prescription Drug User Fee Act (PDUFA) target action date is April 18, 2022.

Supporting Data

Incyte said that the sNDA was supported by data from the Phase 3 TRuE-V clinical trial, which evaluated the safety and efficacy of ruxolitinib cream in more than 600 people with non-segmental vitiligo, aged 12 years and older. The data demonstrated that at week 24, 29.9% of patients applying ruxolitinib cream achieved more than 75% improvement from baseline in the primary endpoint.

About 1.5 million individuals in the U.S. suffer from this chronic autoimmune disease.

Official Comments

Group Vice President of Inflammation & Autoimmunity at Incyte, Jim Lee, said, “Vitiligo is a chronic autoimmune disease that can have a profound impact on people’s lives. Currently, there are no FDA-approved drug therapies for repigmentation in people with vitiligo. The FDA’s acceptance of our sNDA for ruxolitinib cream brings us one step closer to offering patients with vitiligo an additional treatment option.”

Prior Approvals

In September 2021, the FDA approved ruxolitinib cream for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in patients aged 12 and older.

Wall Street’s Take

Recently, Mizuho Securities analyst Mara Goldstein maintained a Hold rating and a price target of $95 (38.5% upside potential) on the stock.

The rest of the Street is cautiously optimistic about the stock, with a Moderate Buy consensus rating based on 8 Buys and 7 Holds. The average Incyte price target of $93.69 implies 36.59% upside potential. Shares have lost 20.5% over the past year. (See Top Analysts Stocks on TipRanks)

Risk Analysis

According to the new TipRanks Risk Factors tool, Incyte stock is at risk mainly from three factors: Legal and Regulatory, Tech and Innovation, and Ability to Sell, which contribute 27%, 24%, and 22%, respectively to the total 41 risks identified for the stock.

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