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Incyte (INCY) Gets FDA Nod for Label Expansion of Pemazyre
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Incyte (INCY - Free Report) recently announced that the FDA has approved a label expansion of cholangiocarcinoma drug Pemazyre (pemigatinib).
The drug, a selective fibroblast growth factor receptor (FGFR) inhibitor, has been approved for treating adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.
MLNs with FGFR1 rearrangement are extremely rare and aggressive blood cancers impacting less than 1 in 100,000 people in the United States.
Pemazyre was earlier granted accelerated approval by the FDA in 2020 for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
The FDA approval was based on data from the phase II FIGHT-203 study, a multicenter open-label, single-arm trial that evaluated the safety and efficacy of Pemazyre in 28 patients with relapsed or refractory MLNs with FGFR1 rearrangement.
The supplemental new drug application (sNDA) for Pemazyre for treating adults with relapsed or refractory MLNs with FGFR1 rearrangement was analyzed by the FDA under Priority Review.
A phase II open-label study evaluating the efficacy and safety of pemigatinib in adults with previously treated glioblastoma or other primary central nervous system tumors harboring activating FGFR1-3 alterations (FIGHT-209) is ongoing. Also, a phase II open-label study evaluating the efficacy and safety of pemigatinib in adults with relapsed or refractory advanced non-small cell lung cancer with an FGFR alteration (FIGHT-210) is continuing.
Shares of Incyte are down 4% in the year compared with the industry’s 23.6% decline.
Image Source: Zacks Investment Research
Incyte’s lead drug Jakafi (a first-in-class JAK1/JAK2 inhibitor) is approved for polycythemiavera, myelofibrosis and refractory acute graft-versus-host disease. Strong demand for the drug has maintained momentum for the company.
Incyte’s pipeline is highly encouraging, and approval of new drugs diversifies the company’s portfolio.
The uptake of Pemazyre and other newly approved drugs like Monjuvi and Tabrecta is also a positive and should boost sales.
However, pipeline setbacks and increased competition for Jakafi are concerns. The company is highly dependent on its lead drug Jakafi for a major chunk of its revenues, and a slowdown will adversely impact sales.
Jakafi is marketed by Incyte in the United States and by Novartis (NVS - Free Report) as Jakavi outside the country
Incyte also earns product royalty revenues from Novartis for the commercialization of Jakafi in ex-U.S. markets.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters.
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Incyte (INCY) Gets FDA Nod for Label Expansion of Pemazyre
Incyte (INCY - Free Report) recently announced that the FDA has approved a label expansion of cholangiocarcinoma drug Pemazyre (pemigatinib).
The drug, a selective fibroblast growth factor receptor (FGFR) inhibitor, has been approved for treating adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.
MLNs with FGFR1 rearrangement are extremely rare and aggressive blood cancers impacting less than 1 in 100,000 people in the United States.
Pemazyre was earlier granted accelerated approval by the FDA in 2020 for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
The FDA approval was based on data from the phase II FIGHT-203 study, a multicenter open-label, single-arm trial that evaluated the safety and efficacy of Pemazyre in 28 patients with relapsed or refractory MLNs with FGFR1 rearrangement.
The supplemental new drug application (sNDA) for Pemazyre for treating adults with relapsed or refractory MLNs with FGFR1 rearrangement was analyzed by the FDA under Priority Review.
A phase II open-label study evaluating the efficacy and safety of pemigatinib in adults with previously treated glioblastoma or other primary central nervous system tumors harboring activating FGFR1-3 alterations (FIGHT-209) is ongoing. Also, a phase II open-label study evaluating the efficacy and safety of pemigatinib in adults with relapsed or refractory advanced non-small cell lung cancer with an FGFR alteration (FIGHT-210) is continuing.
Shares of Incyte are down 4% in the year compared with the industry’s 23.6% decline.
Image Source: Zacks Investment Research
Incyte’s lead drug Jakafi (a first-in-class JAK1/JAK2 inhibitor) is approved for polycythemiavera, myelofibrosis and refractory acute graft-versus-host disease. Strong demand for the drug has maintained momentum for the company.
Incyte’s pipeline is highly encouraging, and approval of new drugs diversifies the company’s portfolio.
The uptake of Pemazyre and other newly approved drugs like Monjuvi and Tabrecta is also a positive and should boost sales.
However, pipeline setbacks and increased competition for Jakafi are concerns. The company is highly dependent on its lead drug Jakafi for a major chunk of its revenues, and a slowdown will adversely impact sales.
Jakafi is marketed by Incyte in the United States and by Novartis (NVS - Free Report) as Jakavi outside the country
Incyte also earns product royalty revenues from Novartis for the commercialization of Jakafi in ex-U.S. markets.
Incyte currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the sector are Bolt Pharmaceuticals (BOLT - Free Report) and Dynavax (DVAX - Free Report) . Both carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters.