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Vertex's Cystic Fibrosis Drug Gets FDA Nod for Children
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Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced FDA approval for its cystic fibrosis drug, Kalydeco (ivacaftor), for expanded use in children aged 12 months to two years.
The approval was based on data from an ongoing phase III study, ARRIVAL, evaluating 25 children who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. A similar line-extension application is under review in the EU with a decision expected in the first half of next year. Meanwhile, Vertex is conducting a phase III study to get Kalydeco approved to treat infants under 12 months of age. Data from this phase III study is expected in the second half of 2018.
So far this year, Vertex’s shares have gained 15.5% against the industry’s decline of 5%.
Kalydeco is a key revenue driver for Vertex. The drug generated sales of $253 million in the quarter, rising 33.2% year over year due to increase in the number of eligible patient population.
Presently, Kalydeco is approved for the treatment of patients with CF, two years and older, who have one of 38 ivacaftor-responsive mutations in the CFTR gene. Supported by a consistent expansion in patient population, Kalydeco is now labelled to treat approximately 6,000 people with CF globally.
Vertex is looking to get Kalydeco approved in additional patient populations and is studying it in combination with other CF candidates.
A combination of Kalydeco and tezacaftor (VX-661) gained FDA approval in February and was launched as Vertex’s third CF medicine, Symdeko, for the treatment of patients with CF twelve years of age and older who are F508del homozygous or who have at least one mutation that is responsive to tezacaftor/ivacaftor. Approval in the EU for Symdeko is expected in the second half of 2018. Symdeko is off to a strong start in the United States and is expected to be a significant contributor to sales in 2018.
Vertex is also evaluating two next-generation CFTR correctors (VX-659 and VX-445) in phase III studies as part of a triple combination with tezacaftor and ivacaftor. Vertex is evaluating both the combinations in two separate studies for F508del/Min and F508del homozygous patients. Enrolment in all these phase III studies is expected to be completed in second half of 2018 with a regulatory submission planned for mid-2019.
Some other top-ranked stocks in the biotech sector are Gilead Sciences (GILD - Free Report) , Ligand Pharmaceuticals (LGND - Free Report) and Biogen (BIIB - Free Report) . While Gilead and Ligand have a Zacks Rank #1, Biogen has a Zacks Rank #2.
Gilead’s earnings estimates increased 7.4% for 2018 and 1.9% for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 6.43%. The company’s shares have increased 4.4% year to date.
Ligand’s earnings estimates increased 14.4% for 2018 and 3.7% for 2019 over the last 30 days. The company delivered a positive earnings surprise in each of the trailing four quarters, with an average beat of 59.54%. The company’s shares have rallied 80.6% year to date.
Biogen’s earnings estimates increased 5.5% for 2018 and 4.1% for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 5.13%. The company’s shares have increased 6.9% year to date.
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Vertex's Cystic Fibrosis Drug Gets FDA Nod for Children
Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced FDA approval for its cystic fibrosis drug, Kalydeco (ivacaftor), for expanded use in children aged 12 months to two years.
The approval was based on data from an ongoing phase III study, ARRIVAL, evaluating 25 children who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. A similar line-extension application is under review in the EU with a decision expected in the first half of next year. Meanwhile, Vertex is conducting a phase III study to get Kalydeco approved to treat infants under 12 months of age. Data from this phase III study is expected in the second half of 2018.
So far this year, Vertex’s shares have gained 15.5% against the industry’s decline of 5%.
Kalydeco is a key revenue driver for Vertex. The drug generated sales of $253 million in the quarter, rising 33.2% year over year due to increase in the number of eligible patient population.
Presently, Kalydeco is approved for the treatment of patients with CF, two years and older, who have one of 38 ivacaftor-responsive mutations in the CFTR gene. Supported by a consistent expansion in patient population, Kalydeco is now labelled to treat approximately 6,000 people with CF globally.
Vertex is looking to get Kalydeco approved in additional patient populations and is studying it in combination with other CF candidates.
A combination of Kalydeco and tezacaftor (VX-661) gained FDA approval in February and was launched as Vertex’s third CF medicine, Symdeko, for the treatment of patients with CF twelve years of age and older who are F508del homozygous or who have at least one mutation that is responsive to tezacaftor/ivacaftor. Approval in the EU for Symdeko is expected in the second half of 2018. Symdeko is off to a strong start in the United States and is expected to be a significant contributor to sales in 2018.
Vertex is also evaluating two next-generation CFTR correctors (VX-659 and VX-445) in phase III studies as part of a triple combination with tezacaftor and ivacaftor. Vertex is evaluating both the combinations in two separate studies for F508del/Min and F508del homozygous patients. Enrolment in all these phase III studies is expected to be completed in second half of 2018 with a regulatory submission planned for mid-2019.
Vertex has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some other top-ranked stocks in the biotech sector are Gilead Sciences (GILD - Free Report) , Ligand Pharmaceuticals (LGND - Free Report) and Biogen (BIIB - Free Report) . While Gilead and Ligand have a Zacks Rank #1, Biogen has a Zacks Rank #2.
Gilead’s earnings estimates increased 7.4% for 2018 and 1.9% for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 6.43%. The company’s shares have increased 4.4% year to date.
Ligand’s earnings estimates increased 14.4% for 2018 and 3.7% for 2019 over the last 30 days. The company delivered a positive earnings surprise in each of the trailing four quarters, with an average beat of 59.54%. The company’s shares have rallied 80.6% year to date.
Biogen’s earnings estimates increased 5.5% for 2018 and 4.1% for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 5.13%. The company’s shares have increased 6.9% year to date.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>