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Shire Gets FDA Approval for Label Expansion of Adynovate
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Shire plc announced that the FDA has approved a label expansion of Adynovate.
Although Shire’s share price decreased 17.7% so far this year, it was much better than the Zacks classified Medical-Drugs industry’s 24.4% decline.
Coming back to the latest news, the FDA has approved the use of Shire’s hemophilia A drug, Adynovate, in pediatric patients under 12 years of age. In addition, Adynovate got the regulatory nod for use in surgical settings for both adult and pediatric patients.
We remind investors that Adynovate is approved in the U.S. for hemophilia A in both adults and children.
The label expansion provides a greater number of hemophilia A patients access to proven prophylaxis with a simple, twice-weekly dosing schedule.
Under a collaboration with Nektar Therapeutics (NKTR - Free Report) , Adynovate leverages proprietary PEGylation technology designed to extend the amount of FVIII available for use in the body.
The drug was added to company’s portfolio through the acquisition of erstwhile Baxalta. Baxalta’s hematology portfolio presently comprises Advate (hemophilia A) and Rixubis (hemophilia B). Shire, on the other hand, is a leader in the ADHD market with drugs like Vyvanse and Intuniv.
Shire has expanded its presence in the gastrointestinal, neuroscience and rare disease markets through strategic acquisitions in recent times. The NPS Pharma acquisition strengthened the company's GI franchise while the Baxalta takeover added key products to its hematology, oncology and immunology franchises.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 86.6% year to date.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 45 cents, while its earnings estimates for 2017 decreased from 13 cents to 9 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 72.9% year to date.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>
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Shire Gets FDA Approval for Label Expansion of Adynovate
Shire plc announced that the FDA has approved a label expansion of Adynovate.
Although Shire’s share price decreased 17.7% so far this year, it was much better than the Zacks classified Medical-Drugs industry’s 24.4% decline.
Coming back to the latest news, the FDA has approved the use of Shire’s hemophilia A drug, Adynovate, in pediatric patients under 12 years of age. In addition, Adynovate got the regulatory nod for use in surgical settings for both adult and pediatric patients.
We remind investors that Adynovate is approved in the U.S. for hemophilia A in both adults and children.
The label expansion provides a greater number of hemophilia A patients access to proven prophylaxis with a simple, twice-weekly dosing schedule.
Under a collaboration with Nektar Therapeutics (NKTR - Free Report) , Adynovate leverages proprietary PEGylation technology designed to extend the amount of FVIII available for use in the body.
The drug was added to company’s portfolio through the acquisition of erstwhile Baxalta. Baxalta’s hematology portfolio presently comprises Advate (hemophilia A) and Rixubis (hemophilia B). Shire, on the other hand, is a leader in the ADHD market with drugs like Vyvanse and Intuniv.
Shire has expanded its presence in the gastrointestinal, neuroscience and rare disease markets through strategic acquisitions in recent times. The NPS Pharma acquisition strengthened the company's GI franchise while the Baxalta takeover added key products to its hematology, oncology and immunology franchises.
Shire currently carries a Zacks Rank #3 (Hold).
SHIRE PLC-ADR Price and Consensus
SHIRE PLC-ADR Price and Consensus | SHIRE PLC-ADR Quote
Key Picks in the Sector
A couple of better-ranked stocks in the health care sector include Heska Corp. and Vanda Pharmaceuticals (VNDA - Free Report) . Both of them sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 86.6% year to date.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 45 cents, while its earnings estimates for 2017 decreased from 13 cents to 9 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 72.9% year to date.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>