Incyte Corporation
INCY
announced that the European Commission has approved its kinase inhibitor, Pemazyre (pemigatinib), for the treatment of adult patients with locally advanced/metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that has progressed after at least one prior line of systemic therapy.
In January 2021, the European Medicines Agency’s Committee for Medicinal Products for Human Use rendered a positive opinion, recommending the conditional marketing authorization of Pemazyre for the given indication.
The approval in Europe was based on data from the FIGHT-202 study which evaluated the safety and efficacy of Pemazyre in adult patients with previously treated, locally advanced/metastatic cholangiocarcinoma with documented FGF/FGFR status. Interim data from the same showed that in patients harboring FGFR2 fusions or rearrangements (Cohort A), treatment with Pemazyre monotherapy led to an overall response rate of 37%, which was the primary endpoint, and median duration of response (DOR) of 8 months, which was the secondary endpoint.
Following the nod, Pemazyre became the first targeted treatment in the EU indicated for treating patients with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement.
Shares of Incyte have declined 6.8% so far this year compared with the
industry’s
decrease of 2.3%.
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We note that cholangiocarcinoma, also known as bile duct cancer, is often diagnosed at an advanced stage when the prognosis is poor. Pemazyre was approved by the FDA in April 2020 for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement.
Notably, Pemazyre generated revenues of $25.8 million since its launch in 2020. The initial uptake of the drug has been encouraging. The approval in Europe should boost sales further in 2021.
Zacks Rank & Stocks to Consider
Incyte currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include
Nabriva Therapeutics AG
NBRV
,
Repligen Corporation
RGEN
and
CytomX Therapeutics, Inc.
CTMX
, all carrying a Zacks Rank #2 (Buy) at present. You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Nabriva Therapeutics’ loss per share estimates have narrowed 45.8% for 2021 and 50.9% for 2022 over the past 60 days.
Repligen’s earnings estimates have been revised 15.1% upward for 2021 and 9.8% for 2022 over the past 60 days.
CytomX Therapeutics’ loss per share estimates have narrowed 40% for 2021 and 31.9% for 2022 over the past 60 days. The stock has rallied 15.9% so far this year.
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