Incyte Corporation (INCY) shares lost 3.46% in after-hours on Tuesday, September 21, 2021, and closed the daily at $73.43. INCY’s stock gained 0.20% in the regular trading session on Tuesday. INCY shares have fallen 10.93% over the last 12 months, and they have moved up 5.29% in the past week. Over the past three months, the stock has lost 10.61%, while over the past six months, it has declined 4.75%.
Let’s see is there any valid reason behind its after-hours loss?
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FDA Approved INCY Opzelura™
On September 21, 2021, the U.S. Food and Drug Administration (FDA) approved Opzelura™ (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies. Opzelura is the first and only topical formulation by Incyte (INCY) of a JAK inhibitor approved in the United States.
INCY received conditional approval for Pemazyre®
On September 17, 2021, Health Canada issued a Notice of Compliance with conditions for Incyte (INCY) Pemazyre® (pemigatinib), which is a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangements.
INCY participation in the upcoming event
Incyte (INCY) will present the multiple abstracts highlighting data for ruxolitinib cream at the upcoming European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress, which will be held virtually from September 29-October 2, 2021.
Approval of INCY’s Minjuvi by the European commission
On August 26, 2021, the European Commission (EC) granted conditional marketing authorization for Minjuvi® (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
The approval came after European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the conditional marketing authorization of Minjuvi in June 2021. Minjuvi® (tafasitamab) is a joint venture of Incyte (INCY) and MorphoSys AG (MOR).
Minjuvi approval in Canada
On August 24, 2021, Incyte (INCY) announced that Health Canada granted a Notice of Compliance with conditions for Minjuvi® (tafasitamab).
Dr. Laurie Sehn, Clinical Professor with BC Cancer Centre for Lymphoid Cancer and The University of British Columbia said that the data from L-MIND demonstrated that eligible patients treated with tafasitamab and lenalidomide had a high likelihood of benefit, which was durable in many cases.
The INCY stock plummeting in the after-hours does not make any sense to us because the company recently received FDA approval for Opzelura, which is positive news and its stock price should be going up. We can expect that to happen in the next trading session on Wednesday.