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Shire's Takhzyro Gets FDA Nod for Hereditary Angioedema
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Shire plc announced that the FDA has approved Takhzyro (lanadelumab-flyo) injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older. Takhzyro is a first-of-its-kind mAb preventive treatment for HAE. The drug is a subcutaneous injection that took the majority of patients one minute or less to self-administer.
Takhzyro was under priority review. It has both Breakthrough Therapy designation and Orphan Drug status.
HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of edema (swelling) in various parts of the body.
Shares of the company increased 9.9% compared with the industry’s growth of 1.6%.
The FDA approval was supported by a phase III HELP study, which showed that patients taking Takhzyro 300 mg every two weeks had an 87% reduction in mean monthly HAE attacks versus placebo, while the patients taking Takhzyro 300 mg every four weeks had 73% reduction in attacks.
A pre-specified, exploratory analysis showed that 44% of patients (n=27) receiving Takhzyro 300 mg every two weeks had zero attacks compared to placebo for the 26-week treatment period. Further, a post hoc analysis of the 16-week period from day 70 to day 182 showed that 77% of patients (n=26) treated with Takhzyro in the same dosage arm of the study were attack-free compared to placebo.
From the Takhzyro arm, 97% of the patients who completed the HELP study opted in to an ongoing open-label extension study designed to evaluate the long-term safety and efficacy of the drug.
We remind investors that Takhzyro was added to Shire’s HAE portfolio with the acquisition of Dyax Corp., which was completed in January 2016. The acquisition also added another candidate, Kalbitor to the company’s portfolio, which is under review in the United States and Europe (decision expected in second half of 2018), is also being developed for HAE. The company also has Cinryze in its portfolio for the treatment of HAE. Cinryze is the first C1 esterase inhibitor (C1-INH) approved by the FDA to help prevent swelling attacks in children (6 years of age and older), teenagers and adults.
Some better-ranked stocks in the biotech sector are Gilead Sciences Inc. (GILD - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Celgene Corp. . While Gilead and Ligand sport a Zacks Rank #1 (Strong Buy), Celgene carries a Zacks Rank #2 (Buy).You can seethe complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.15 to $6.57 for 2018 and from $6.33 to $6.48 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 2.3% so far this year.
Ligand’s earnings per share estimates moved up from $4.93 to $5.64 for 2018 and from $5.39 to $5.59 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 59.5%. Share price of the company has increased 82.5% year to date.
Celgene’s earnings per share estimates have increased from $8.54 to $8.76 for 2018 and from $10.19 to $10.65 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 2.38%.
5 Medical Stocks to Buy Now
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
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Shire's Takhzyro Gets FDA Nod for Hereditary Angioedema
Shire plc announced that the FDA has approved Takhzyro (lanadelumab-flyo) injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older. Takhzyro is a first-of-its-kind mAb preventive treatment for HAE. The drug is a subcutaneous injection that took the majority of patients one minute or less to self-administer.
Takhzyro was under priority review. It has both Breakthrough Therapy designation and Orphan Drug status.
HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of edema (swelling) in various parts of the body.
Shares of the company increased 9.9% compared with the industry’s growth of 1.6%.
The FDA approval was supported by a phase III HELP study, which showed that patients taking Takhzyro 300 mg every two weeks had an 87% reduction in mean monthly HAE attacks versus placebo, while the patients taking Takhzyro 300 mg every four weeks had 73% reduction in attacks.
A pre-specified, exploratory analysis showed that 44% of patients (n=27) receiving Takhzyro 300 mg every two weeks had zero attacks compared to placebo for the 26-week treatment period. Further, a post hoc analysis of the 16-week period from day 70 to day 182 showed that 77% of patients (n=26) treated with Takhzyro in the same dosage arm of the study were attack-free compared to placebo.
From the Takhzyro arm, 97% of the patients who completed the HELP study opted in to an ongoing open-label extension study designed to evaluate the long-term safety and efficacy of the drug.
We remind investors that Takhzyro was added to Shire’s HAE portfolio with the acquisition of Dyax Corp., which was completed in January 2016. The acquisition also added another candidate, Kalbitor to the company’s portfolio, which is under review in the United States and Europe (decision expected in second half of 2018), is also being developed for HAE. The company also has Cinryze in its portfolio for the treatment of HAE. Cinryze is the first C1 esterase inhibitor (C1-INH) approved by the FDA to help prevent swelling attacks in children (6 years of age and older), teenagers and adults.
Shire plc Price
Shire plc Price | Shire plc Quote
Zacks Rank & Stocks to Consider
Shire has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Gilead Sciences Inc. (GILD - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Celgene Corp. . While Gilead and Ligand sport a Zacks Rank #1 (Strong Buy), Celgene carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.15 to $6.57 for 2018 and from $6.33 to $6.48 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 2.3% so far this year.
Ligand’s earnings per share estimates moved up from $4.93 to $5.64 for 2018 and from $5.39 to $5.59 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 59.5%. Share price of the company has increased 82.5% year to date.
Celgene’s earnings per share estimates have increased from $8.54 to $8.76 for 2018 and from $10.19 to $10.65 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 2.38%.
5 Medical Stocks to Buy Now
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
Click here to see the 5 stocks >>