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Vertex Combo Data on Kalydeco+VX-661 Positive in Phase III
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Vertex Pharmaceuticals Incorporated’s (VRTX - Free Report) shares were up almost 19% in pre-market trading after the company announced positive data from two phase III studies evaluating its lead marketed drug Kalydeco (ivacaftor) in combination with tezacaftor VX-661 (tezacaftor) in patients suffering from cystic fibrosis (CF) aged 12 years and above with two copies of the F508del mutation.
We note that Kalydeco is already approved in the U.S., EU, Australia and Canada for the treatment of certain patients with CF who have specific mutations in their CFTR (cystic fibrosis transmembrane conductance regulator) gene.
Vertex’s shares have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. Shares of the company gained 21.7% while the industry registered an increase of 6%.
Both studies – EVOLVE and EXPAND – met their primary endpoints and demonstrated statistically significant improvements in lung function in patients with CF. The first study, EVOLVE (n=500), showed a mean absolute improvement of 4% points in ppFEV1 (percent predicted forced expiratory volume in one second) through 24 weeks versus placebo. The second study, EXPAND (n=250), showed an absolute change of 6.8% points in ppFEV1 from baseline to the average of the Week 4 and Week 8 measurements versus placebo. The combination treatment was found to be well tolerated in both the studies.
We note that the company is planning to submit a new drug application (NDA) to the FDA and a marketing authorization application (MAA) to the EU in the third quarter of 2017. The application will be based on positive outcome from the studies for the aforesaid indication.
Per the company’s press release, approximately 75,000 people in North America, Europe and Australia suffer from CF. In fact, more than 29% people of ages 12 years or older have two copies of the F508del mutation, and more than 1,500 people of the age 12 have one mutation. Hence, approval of the drug will provide the company access to a huge base of patients affected by the disease and bring it closer to the goal of serving all people with the disease.
We remind investors that Vertex remains focused on CF treatments. The company has two CF drugs – Kalydeco & Orkambi – in its portfolio with blockbuster potential. While Orkambi accounted for more than 57% of the company’s top line, Kalydeco accounted for 41% in 2016. Moreover, Orkambi and Kalydeco, together are approved to treat approximately 40% of the 75,000 CF patients in North America, Europe and Australia.
However, Kalydeco sales are not expected to improve significantly in 2017 as the drug has almost fully penetrated the eligible population. Vertex expects Kalydeco sales in the range of $690–$710 million in 2017.
Vertex currently carries a Zacks Rank #2 (Buy). Some favorably placed stocks in the health care sector include Heska Corporation , Galena Biopharma, Inc. and Retrophin, Inc. . Each of these stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.80 to $2.01 for 2018 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Galena’s loss per share estimates narrowed from $2.03 to 58 cents for 2017 and over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 53.83%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
More Stock News: 8 Companies Verge on Apple-Like Run
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Vertex Combo Data on Kalydeco+VX-661 Positive in Phase III
Vertex Pharmaceuticals Incorporated’s (VRTX - Free Report) shares were up almost 19% in pre-market trading after the company announced positive data from two phase III studies evaluating its lead marketed drug Kalydeco (ivacaftor) in combination with tezacaftor VX-661 (tezacaftor) in patients suffering from cystic fibrosis (CF) aged 12 years and above with two copies of the F508del mutation.
We note that Kalydeco is already approved in the U.S., EU, Australia and Canada for the treatment of certain patients with CF who have specific mutations in their CFTR (cystic fibrosis transmembrane conductance regulator) gene.
Vertex’s shares have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. Shares of the company gained 21.7% while the industry registered an increase of 6%.
Both studies – EVOLVE and EXPAND – met their primary endpoints and demonstrated statistically significant improvements in lung function in patients with CF. The first study, EVOLVE (n=500), showed a mean absolute improvement of 4% points in ppFEV1 (percent predicted forced expiratory volume in one second) through 24 weeks versus placebo. The second study, EXPAND (n=250), showed an absolute change of 6.8% points in ppFEV1 from baseline to the average of the Week 4 and Week 8 measurements versus placebo. The combination treatment was found to be well tolerated in both the studies.
We note that the company is planning to submit a new drug application (NDA) to the FDA and a marketing authorization application (MAA) to the EU in the third quarter of 2017. The application will be based on positive outcome from the studies for the aforesaid indication.
Per the company’s press release, approximately 75,000 people in North America, Europe and Australia suffer from CF. In fact, more than 29% people of ages 12 years or older have two copies of the F508del mutation, and more than 1,500 people of the age 12 have one mutation. Hence, approval of the drug will provide the company access to a huge base of patients affected by the disease and bring it closer to the goal of serving all people with the disease.
We remind investors that Vertex remains focused on CF treatments. The company has two CF drugs – Kalydeco & Orkambi – in its portfolio with blockbuster potential. While Orkambi accounted for more than 57% of the company’s top line, Kalydeco accounted for 41% in 2016. Moreover, Orkambi and Kalydeco, together are approved to treat approximately 40% of the 75,000 CF patients in North America, Europe and Australia.
However, Kalydeco sales are not expected to improve significantly in 2017 as the drug has almost fully penetrated the eligible population. Vertex expects Kalydeco sales in the range of $690–$710 million in 2017.
Vertex Pharmaceuticals Incorporated Price
Vertex Pharmaceuticals Incorporated Price | Vertex Pharmaceuticals Incorporated Quote
Zacks Rank & Key Picks
Vertex currently carries a Zacks Rank #2 (Buy). Some favorably placed stocks in the health care sector include Heska Corporation , Galena Biopharma, Inc. and Retrophin, Inc. . Each of these stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.80 to $2.01 for 2018 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Galena’s loss per share estimates narrowed from $2.03 to 58 cents for 2017 and over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 53.83%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>