Incyte Corporation (INCY) stock prices were up by 0.20% as of the market closing on September 21st, 2021. This brought the price per share up to USD$76.06 at the end of the trading day. Subsequent premarket fluctuations saw the stock dip by 2.41%, bringing it down to USD$ 74.23.
INCY Stock’s U.S FDA Approval
September 21st, 2021 saw INCY stock announce the approval of its Opzelura cream by the United States Food and Drug Administration. The ruxolitinib cream is designed to treat short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD). The treatment is used by non-immunocompromised patients above the age of 11 years. These patients’ diseases are not adequately controlled with topical prescription therapies, or when existing therapies are not advisable. The treatment is the first of its kind and the only topical formulation of a JAK inhibitor that has been approved in the U.S.
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INCY Stock’s Opzelura
Research has indicated that dysregulation of the JAK-STAT pathway contributes to key features of AD. These include, but are not limited to, itch, inflammation, and skin barrier dysfunction. Atopic dermatitis is a chronic immune-mediated disease that has proven to be troublesome to manage. Many patients fail to respond adequately to existing treatments, resulting in an uncontrolled disease.
Scope of Opzelura
Opzelura’s approval is a key milestone in the treatment of AD, with the company excited to offer a novel topical treatment option. The treatment targets the pathway that is believed to be a source of inflammation. INCY stock is committed to transforming the treatment of immune-mediated dermatologic conditions like AD. As such, it is pushing for the accelerated proliferation of its treatment, which is thought to also have potential in treating other challenging skin diseases.
Details of Opzelura
The U.S FDA approval for Opzelura was based on data from the TRuE-AD clinical trial program. The study consisted of two randomized, double-blind, vehicle-controlled Phase 3 studies. These studies were designed to evaluate the safety and efficacy of the treatment in more than 1200 adolescents and adults with mild to moderate AD. The study results showed patients experienced significantly clearer skin and itch reduction. These results were exhibited after treatment with Opzelura cream 1.5% twice a day, as compared to non-medicated cream.
Future Outlook for INCY Stock
The company reported a promising quarter, as evidenced by the approval of its proprietary Opzelura by the U.S FDA. INCY stock is poised to capitalize on the accelerated commercialization and proliferation of the treatment around the globe. Current and potential investors are hopeful that this will result in sustained and organic increases in shareholder value over the long term.