Incyte Corporation (INCY) recently notified that its intravenous PD-1 inhibitor, retifanlimab, cannot be approved by the FDA for the treatment of specific cancer patients. However, Incyte may be able to get the approval if they submit further elaboration on the clinical benefits of retifanlimab for the treatment of advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) as an alternative to platinum-based chemotherapy.
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Incyte had earlier submitted an application for approval based on data from the Phase 2 POD1UM-202 trial, which presented an analysis of the effects of retifanlimab in former patients. (See Incyte stock chart on TipRanks)
The Chief Executive Officer of Incyte, Hervé Hoppenot, said, “Patients with SCAC who have progressed after first-line chemotherapy currently do not have approved treatment options. While we are not surprised with the FDA decision given the ODAC recommendation, we are disappointed. We remain committed to advancing science to find solutions for patients with unmet medical needs, and we will ensure close coordination with the FDA in order to address feedback and determine next steps for the review of retifanlimab.”
On July 20, Benchmark Co. analyst Aydin Huseynov upgraded the rating of Incyte to a Buy and reiterated the price target of $89. The price target implies 12.2% upside potential.
Huseynov said that the company’s recently published data for chronic GVHD treatment —ruxolitinib — showed the candidate “performed better than each of the individual components in the best available arm.” Graft versus host disease, or GVHD, is a side effect of an allogeneic transplant in which the donor cells attack the recipient’s body. The ruxolitinib drug is marketed under the name Jakafi.
The analyst further noted that if the FDA approved ruxolitinib, it would bode well for the sales of Jakafi for not only GVHD but also three other indications.
Consensus among analysts is a Moderate Buy based on 5 Buys, 3 Holds and 1 Sell. The average Incyte price target of $99.88 implies 26% upside potential to current levels.
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