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Incyte's Application for Pemigatinib Gets EMA's Validation

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Incyte Corporation INCY announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for its investigational FGFR inhibitor pemigatinib to treat adult patients with locally advanced/metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy. Cholangiocarcinoma is also known as bile-duct cancer.

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

We remind investors that in November 2019, the FDA accepted and granted a priority review to the new drug application (NDA) for pemigatinib as a second-line treatment of locally advanced or metastatic cholangiocarcinoma. A decision from the regulatory body is expected on May 30, 2020.

The NDA too was based on data from the phase II FIGHT-202 study. Results from the same showed that treatment with pemigatinib monotherapy led to an overall response rate (ORR) of 36% (primary endpoint) and a median duration of response (DOR) of 7.5 months (secondary endpoint) with a median follow-up of 15 months. No serious side effects were reported.

Shares of Incyte have increased 4.7% in the past year against its industry’s decrease of 2.4%.

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

Notably, in June 2019, Incyte initiated a phase III study on pemigatinib for the first-line treatment of patients with cholangiocarcinoma and FGFR2 fusions or rearrangements. The candidate is also being evaluated in a phase II study for bladder cancer.

We would like to remind investors that Agios Pharmaceuticals AGIO is also evaluating its leukemia drug Tibsovo in the phase III ClarIDHy study for addressing previously treated patients with IDH1 mutant cholangiocarcinoma. The company plans to file a supplemental new drug application (sNDA) to the FDA for Tibsovo to treat cholangiocarcinoma. Currently, there are no treatment options available to treat this cancer.

Zacks Rank & Stocks to Consider

Incyte currently carries a Zacks Rank #4 (Sell). Better-ranked stocks in the biotech sector include Emergent Biosolutions Inc. (EBS - Free Report) and Alexion Pharmaceuticals, Inc. ALXN, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have moved 5.6% north for 2020 over the past 60 days.

Alexion’s earnings estimates have been revised 0.4% upward for 2020 over the past 60 days.

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