Incyte announced that the US Food and Drug Administration (FDA) has granted priority review for the New Drug Application (NDA) of its ruxolitinib cream. Shares of the biopharmaceutical company declined around 1.2% to close at $80.54 on Feb. 19.
A priority review voucher (PRV) was submitted by Incyte (INCY) along with the NDA application, which shortens the review period by four months.
The ruxolitinib cream is a selective JAK1/JAK2 inhibitor for topical application and is targeted to treat atopic dermatitis (AD), a type of eczema.
Incyte said that the NDA was supported by clinical trial data, which showed that the application of ruxolitinib cream was safe and effective in patients with AD in individuals 12 years and older who are undergoing topical therapy.
About 21 million individuals in the US are suffering from this chronic skin disease. (See Incyte stock analysis on TipRanks)
Incyte Group Vice President Jim Lee said, “We are grateful to the people living with atopic dermatitis whose participation in our clinical trials helped generate the evidence to support this regulatory submission, and we look forward to working with the FDA as we seek to bring forward a new topical treatment for people living with this chronic skin disease.”
On Feb. 9, Mizuho Securities analyst Mara Goldstein reiterated a Hold rating on the stock with a price target of $95 (18% upside potential). The analyst expects “positive signs from” the company’s “pipeline and strong cash flow from JAKAFI,” but is cautious, “on greater valuation expansion for the shares.”
The rest of the Street is cautiously optimistic about the stock with a Moderate Buy consensus rating. That’s based on 4 analysts suggesting a Buy, 4 analysts recommending a Hold, and 1 analyst suggesting a Sell. The average analyst price target of $97 implies around 20% upside potential to current levels. Shares have gained about 1.6% over the past year.
Incyte scores an 8 of 10 from TipRanks’ Smart Score rating system, indicating that the stock has strong potential to outperform market expectations.
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