Send me real-time posts from this site at my email
Zacks

Jazz Pharmaceuticals' sNDA for Xyrem Gets Priority Review

Jazz Pharmaceuticals plc JAZZ announced that the FDA has accepted the supplemental new drug application (sNDA) for narcolepsy drug, Xyrem. The sNDA is seeking label expansion of the drug for the treatment for cataplexy and excessive daytime sleepiness (“EDS”) in pediatric patients. The FDA has granted priority review to the sNDA and a decision is expected by Oct 27, 2018.

The drug is currently approved to treat the same indications in adult patients.

Shares of the company have rallied 29.6% so far this year against the industry's 2.1% decrease.

 

The sNDA included data from long-term phase II/III EXPRESS study evaluating Xyrem in patients aged seven to 17 years. The study was initiated upon request from the FDA. Data showed that Xyrem reduced cataplexy and EDS for up to one year in such patients.

Xyrem is the majority revenue source for the company, generating three-quarters of the total sales. Xyrem’s sales were $316.8 million in the first quarter of 2018. A potential approval in pediatric patients will likely boost sales as the eligible patient population increases.

However, several companies are also developing their candidates for the treatment of cataplexy and EDS in narcolepsy patients including Avadel Pharmaceuticals plc AVDL. Moreover, a few companies are trying to bring the generic version of Xyrem in the market. Jazz has settled such litigations with some companies including privately-held West-Ward Pharmaceuticals and Par Pharmaceutical, which have restricted a generic entry till Jan 1, 2023.

The entry of either a branded or generic drug is expected to severely impact Jazz’s top line.

Apart from Xyrem, Jazz’s another narcolepsy candidate, JZP-110, is under review for the treatment of EDS. A decision is expected in December.

 

Zacks Rank & Key Picks

Jazz currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks from the same space are Aeglea BioTherapeutics, Inc. AGLE and ANI Pharmaceuticals, Inc. ANIP. Both the stocks carry a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aeglea’s loss per share estimates narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. The stock has rallied 101.3% so far this year.

ANI Pharmaceuticals’ earnings per share estimates moved up from $5.54 to $5.70 for 2018 and from $5.72 to $6.15 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 8.69%. The stock has rallied 3.9% so far this year.

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 >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis Report
 
Aeglea BioTherapeutics, Inc. (AGLE): Free Stock Analysis Report
 
Jazz Pharmaceuticals PLC (JAZZ): Free Stock Analysis Report
 
Avadel Pharmaceuticals PLC. (AVDL): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research

Welcome! Is it your First time here?

What are you looking for? Select your points of interest to improve your first-time experience:

Apply & Continue