We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Incyte (INCY) Gets EU Nod for Cholangiocarcinoma Drug Pemazyre
Read MoreHide Full Article
Incyte Corporation (INCY - Free Report) 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%.
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.
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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
Image: Bigstock
Incyte (INCY) Gets EU Nod for Cholangiocarcinoma Drug Pemazyre
Incyte Corporation (INCY - Free Report) 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%.
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 , Repligen Corporation (RGEN - Free Report) and CytomX Therapeutics, Inc. (CTMX - Free Report) , 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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>