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Shire's (SHPG) ADHD Drug Mydayis Receives Approval in US

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Shire Plc SHPG announced that the FDA has approved its new attention deficit hyperactivity disorder (ADHD) drug, Mydayis (mixed salts of a single-entity amphetamine product) in patients 13 years and older. The drug is approved as a once-daily treatment consisting of three different types of drug-releasing beads for patients.

The company’s shares were up 1.34% after the announcement of the news. However, the stock has underperformed the Zacks classified Medical – Drugs industry so far this year. Shire’s shares have fallen 1.9% whereas the industry rose 5.5% in the same period.

The approval from the FDA is based on data from 16 studies evaluating Mydayis in adolescents and adults with ADHD in comparison to a placebo. The results showed that the drug achieved statistically significant improvement beginning after 2 or 4 hours of dosing and lasting up to 16 hours post-dose.

The company is planning to launch Mydayis commercially in the third quarter.

Shire is a leader in the ADHD market with drugs like Intuniv, Adderall XR and Vyvanse. Vyvanse, the growth engine for the company, generated sales of $563.7 million in the first quarter of 2017, up 11% from the year ago period. The sales for the drug were $2.0 billion for 2016, up 16.9% year over year.

The adult ADHD space is one of the largest and fastest growing segments of the market and approval of new drugs will further strengthen Shire’s dominant position in that market. However, Shire faces competition from branded stimulants in the ADHD segment in the U.S. from Johnson & Johnson’s JNJ Concerta and Pfizer Inc.’s (PFE - Free Report) Quillivant.

Shire PLC Price and Consensus

Shire PLC Price and Consensus | Shire PLC Quote

Zacks Rank& Stock to Consider

Shire currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the healthcare sector is VIVUS, Inc. VVUS sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates narrowed from 50 cents to 39 cents for 2017 in the last 60 days. The company delivered positive earnings surprises in all four trailing quarters with an average beat of 233.69%.

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