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Shire Gets FDA Approval for Label Expansion of Adynovate

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Shire plcSHPG 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 , 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. HSKA and Vanda Pharmaceuticals VNDA . 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.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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