Stock Update (NASDAQ:HZNP): Horizon Pharma PLC Announces That Health Canada Determines RAVICTI(R) (Glycerol Phenylbutyrate) Oral Liquid Is Eligible for Data Protection

Horizon Pharma PLC (NASDAQ:HZNP), a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, announced that the Therapeutic Products Directorate of Health Canada has determined that RAVICTI® (Glycerol Phenylbutyrate) Oral Liquid is eligible for data protection as it is an “innovative drug” as defined by section C.08.004.1 Food and Drug Regulations.

Subject to final review, if the RAVICTI New Drug Submission (NDS) receives a notice of compliance, RAVICTI would be added to the Register of Innovative Drugs and receive data protection for a term of eight years from the date of the issuance of the notice of compliance. The RAVICTI NDS was originally filed on April 24, 2014 and has been the subject of a stay since June 12, 2015 pending a final determination on data protection.

“This decision is a significant step toward making RAVICTI available in Canada and we look forward to reinitiating the regulatory review process in order to get this innovative medicine to the approximately 100 patients who have urea cycle disorders and who may benefit from treatment as quickly as possible,” said Jared Rhines, vice president and general manager, Canada, LATAM and APAC, Horizon Pharma plc. (Original Source)

Shares of Horizon Pharma closed last Friday at $18.27. HZNP has a 1-year high of $39.49 and a 1-year low of $12.86. The stock’s 50-day moving average is $18.10 and its 200-day moving average is $21.78.

On the ratings front, Horizon Pharma has been the subject of a number of recent research reports. In a report issued on February 16, Brean Murray Carret analyst Difei Yang maintained a Buy rating on HZNP, with a price target of $32, which implies an upside of 75.2% from current levels. Separately, on January 25, Mizuho’s Irina Rivkind Koffler maintained a Buy rating on the stock and has a price target of $36.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Difei Yang and Irina Rivkind Koffler have a total average return of -19.3% and 33.4% respectively. Yang has a success rate of 23.9% and is ranked #3611 out of 3637 analysts, while Koffler has a success rate of 57.8% and is ranked #5.

The street is mostly Bullish on HZNP stock. Out of 8 analysts who cover the stock, 6 suggest a Buy rating , one suggests a Sell and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $34.33, which represents a potential upside of 87.9% from where the stock is currently trading.

Horizon Pharma PLC is a specialty pharmaceutical company. The Company’s product portfolio consists of ACTIMMUNE, DUEXIS, PENNSAID 2% and RAYOS/LODOTRA, which addresses the unmet therapeutic needs in arthritis, pain, inflammatory and/or orphan diseases.

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