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Incyte (INCY) Gets Positive CHMP Opinion for Pemigatinib
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Incyte (INCY - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization of its investigational fibroblast growth factor receptor 2 (FGFR2) inhibitor pemigatinib. The company is seeking approval of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that is relapsed or refractory, after at least one line of systemic therapy.
Cholangiocarcinoma is a rare type of cancer that forms in the bile duct.
Shares of the company have increased 23.1% compared with the industry’s growth of 14.5%.
The CHMP opinion is supported by data from the FIGHT-202 study. The phase II study is evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity. The study showed that in patients harboring FGFR2 fusions or rearrangements (Cohort A), Pemazyre monotherapy resulted in an overall response rate of 36% which was the primary endpoint), and median duration of response (DOR) of 9.1 months which was the secondary endpoint. If approved, pemigatinib will be the first targeted treatment in the EU indicated for patients with unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement. Pemigatinibwould be commercialized under the brand name,Pemazyre.
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 from this dreadful disease and drive growth for Incyte in the future.
We note that, Pemazyre (pemigatinib), 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. Pemazyre is the first and only FDA-approved treatment for this indication.
Zacks Rank & Other Key Picks
Incytecurrently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Acorda Therapeutics Inc. , Anavex Life Sciences Corp. (AVXL - Free Report) and Alexion Pharmaceuticals Inc. . While Acordasportsa Zacks Rank #1 (Strong Buy), Anavex and Alexion carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have narrowed from $9.66 to $8.48 for 2020 and from $9.60 to $7.33 for 2021 over the past 60 days.
Anavex’s loss per share estimates have narrowed from 48 cents to 46 cents for 2021 over the past 60 days. Shares of the company have increased 103% in the past year.
Alexion’s earnings per share estimates have increased from $12.04 to $12.06 for 2020 over the past 60 days. Shares of the company have increased 52% in the past year.
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Incyte (INCY) Gets Positive CHMP Opinion for Pemigatinib
Incyte (INCY - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization of its investigational fibroblast growth factor receptor 2 (FGFR2) inhibitor pemigatinib. The company is seeking approval of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that is relapsed or refractory, after at least one line of systemic therapy.
Cholangiocarcinoma is a rare type of cancer that forms in the bile duct.
Shares of the company have increased 23.1% compared with the industry’s growth of 14.5%.
The CHMP opinion is supported by data from the FIGHT-202 study. The phase II study is evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity. The study showed that in patients harboring FGFR2 fusions or rearrangements (Cohort A), Pemazyre monotherapy resulted in an overall response rate of 36% which was the primary endpoint), and median duration of response (DOR) of 9.1 months which was the secondary endpoint. If approved, pemigatinib will be the first targeted treatment in the EU indicated for patients with unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement. Pemigatinibwould be commercialized under the brand name,Pemazyre.
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 from this dreadful disease and drive growth for Incyte in the future.
We note that, Pemazyre (pemigatinib), 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. Pemazyre is the first and only FDA-approved treatment for this indication.
Zacks Rank & Other Key Picks
Incytecurrently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Acorda Therapeutics Inc. , Anavex Life Sciences Corp. (AVXL - Free Report) and Alexion Pharmaceuticals Inc. . While Acordasportsa Zacks Rank #1 (Strong Buy), Anavex and Alexion carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have narrowed from $9.66 to $8.48 for 2020 and from $9.60 to $7.33 for 2021 over the past 60 days.
Anavex’s loss per share estimates have narrowed from 48 cents to 46 cents for 2021 over the past 60 days. Shares of the company have increased 103% in the past year.
Alexion’s earnings per share estimates have increased from $12.04 to $12.06 for 2020 over the past 60 days. Shares of the company have increased 52% in the past year.
Incyte Corporation Price
Incyte Corporation price | Incyte Corporation Quote
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