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Alexion (ALXN) Offers Long-Term Phase III Data on Kanuma
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Alexion Pharmaceuticals, Inc. revealed new long-term data from an ongoing, open-label extension of the pivotal phase III ARISE study on Kanuma (sebelipase alfa) in children and adults with lysosomal acid lipase deficiency (LAL-D). Data was presented at the annual meeting of the American Association for the Study of Liver Diseases.
Data demonstrated that two-third of the patients treated with Kanuma for 52 weeks experienced a reduction in the liver fibrosis stage from baseline while half of them achieved at least a two-stage reduction, including patients who had fibrosis and cirrhosis at baseline. Moreover, the reduction of the liver fibrosis stage was accompanied by sustained improvements in alanine aminotransferase (ALT), LDL cholesterol and liver fat content in the Kanuma arm.
Long-term data from the ARISE study also demonstrated rapid and consistent improvement in important markers of liver injury and lipid abnormalities in children and adults with LAL-D, when treated with Kanuma. In 76 weeks of treatment with Kanuma, nearly all patients (98%) witnessed a sustained reduction in ALT levels, with a mean reduction from baseline of 56%.
The new data is quite encouraging as it underscores the benefits of treatment with Kanuma. According to the company, LAL-D is a genetic, chronic and progressive ultra-rare metabolic disease that can lead to life-threatening consequences, including cirrhosis and severe dyslipidemia.
We note that Kanuma is the first and only approved treatment for patients with LAL-D. The company has received approval for the drug in the U.S., the EU and Japan. It was launched in the U.S. in early first-quarter 2016.
We remind investors that Kanuma became part of Alexion’s portfolio following the Jun 2015 acquisition of Synageva BioPharma. We expect investor focus to remain on the commercialization and sales ramp-up efforts for the drug.
Alexion currently has a Zacks Rank #5 (Strong Sell)
Catalyst Pharma’s loss estimates narrowed from 27 cents to 25 cents for 2016 and from 28 cents to 24 cents for 2017 over the last 60 days. The company has posted a positive average beat of 10.42%.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company has posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained 19.4% year to date.
Exelixis’ loss estimates narrowed from 71 cents to 51 cents for 2016 and from a loss of 16 cents to earnings of 4 cents for 2017 over the last 60 days. The company has posted a positive surprise thrice in the four trailing quarters with an average beat of 38.52%. Its share price has skyrocketed above 150% year to date.
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Alexion (ALXN) Offers Long-Term Phase III Data on Kanuma
Alexion Pharmaceuticals, Inc. revealed new long-term data from an ongoing, open-label extension of the pivotal phase III ARISE study on Kanuma (sebelipase alfa) in children and adults with lysosomal acid lipase deficiency (LAL-D). Data was presented at the annual meeting of the American Association for the Study of Liver Diseases.
Data demonstrated that two-third of the patients treated with Kanuma for 52 weeks experienced a reduction in the liver fibrosis stage from baseline while half of them achieved at least a two-stage reduction, including patients who had fibrosis and cirrhosis at baseline. Moreover, the reduction of the liver fibrosis stage was accompanied by sustained improvements in alanine aminotransferase (ALT), LDL cholesterol and liver fat content in the Kanuma arm.
Long-term data from the ARISE study also demonstrated rapid and consistent improvement in important markers of liver injury and lipid abnormalities in children and adults with LAL-D, when treated with Kanuma. In 76 weeks of treatment with Kanuma, nearly all patients (98%) witnessed a sustained reduction in ALT levels, with a mean reduction from baseline of 56%.
The new data is quite encouraging as it underscores the benefits of treatment with Kanuma. According to the company, LAL-D is a genetic, chronic and progressive ultra-rare metabolic disease that can lead to life-threatening consequences, including cirrhosis and severe dyslipidemia.
We note that Kanuma is the first and only approved treatment for patients with LAL-D. The company has received approval for the drug in the U.S., the EU and Japan. It was launched in the U.S. in early first-quarter 2016.
We remind investors that Kanuma became part of Alexion’s portfolio following the Jun 2015 acquisition of Synageva BioPharma. We expect investor focus to remain on the commercialization and sales ramp-up efforts for the drug.
Alexion currently has a Zacks Rank #5 (Strong Sell)
ALEXION PHARMA Price
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Stocks to Consider
Some better-ranked stocks in the healthcare sector include Catalyst Pharmaceuticals , Inc. (CPRX - Free Report) , Anika Therapeutics (ANIK - Free Report) and Exelixis, Inc. (EXEL - Free Report) . Anika sports a Zacks Rank #1 (Strong Buy), while both Catalyst Pharma and Exelixis hold Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Catalyst Pharma’s loss estimates narrowed from 27 cents to 25 cents for 2016 and from 28 cents to 24 cents for 2017 over the last 60 days. The company has posted a positive average beat of 10.42%.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company has posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained 19.4% year to date.
Exelixis’ loss estimates narrowed from 71 cents to 51 cents for 2016 and from a loss of 16 cents to earnings of 4 cents for 2017 over the last 60 days. The company has posted a positive surprise thrice in the four trailing quarters with an average beat of 38.52%. Its share price has skyrocketed above 150% year to date.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>