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Incyte's NDA for Pemigatinib Gets FDA's Priority Review Tag

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Incyte Corporation (INCY - Free Report) announced that the FDA has accepted its new drug application (NDA) for its investigational FGFR inhibitor pemigatinib as a second-line treatment of locally advanced or metastatic cholangiocarcinoma also known as bile-duct cancer.

With the FDA granting priority review to the NDA, a decision from the regulatory body is expected on May 30, 2020.

The priority review of pemigatinib will reduce its review time to eight months from the standard duration of 12 months.

The NDA was based on data from the phase II FIGHT-202 study, which evaluated the safety and efficacy of pemigatinib in the given patient population.

Data from the study showed that treatment with pemigatinib monotherapy led to an overall response rate (ORR) of 36% (primary endpoint) and median duration of response (DOR) of 7.5 months (secondary endpoint) with a median follow-up of 15 months. No serious adverse side effects were reported.

Shares of Incyte have soared 48% so far this year compared with the industry’s rise of 4.5%.


Cholangiocarcinoma is often diagnosed at an advanced stage when the prognosis is poor. Hence a potential approval of pemigatinib will provide a new treatment option for patients suffering this dreadful disease and drive growth for Incyte in the future.

In June 2019, the company initiated a phase III study on pemigatinib for the first-line treatment of patients with FGFR2 translocated cholangiocarcinoma. The candidate is also being evaluated in a phase II study for bladder cancer. Several other mid-stage studies on pemigatinib are underway as well.

We remind investors that Agios Pharmaceuticals (AGIO - Free Report) is also evaluating its leukemia drug Tibsovo for addressing previously treated patients with IDH1 mutant cholangiocarcinoma. The company plans to file a supplemental new drug application (sNDA) to the FDA by this year-end for Tibsovo to treat cholangiocarcinoma.

Zacks Rank & Other Stocks to Consider

Incyte currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the biotech sector include Anika Therapeutics Inc. (ANIK - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings estimates have moved 16% north for 2019 and 17.4% for 2020 over the past 60 days. The stock has soared 71.1% so far this year.

Vertex’s earnings estimates have been revised 5% upward for 2019 and 10.6% for 2020 over the past 60 days. The stock has surged 32.8% year to date.

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