Endo Pharmaceuticals Inc., a subsidiary of Endo International plc – Ordinary Shares (NASDAQ:ENDP) announced that, based on discussions with the U.S. Food and Drug Administration (FDA), the Company has been notified that an Advisory Committee of the FDA will be convened in the fall of 2016 to review the Company’s Supplemental New Drug Application (sNDA) for OPANA® ER. As a result of the Advisory Committee meeting, the current Prescription Drug User Fee Act (PDUFA) date of July 29, 2016 for the OPANA® ER sNDA will not be met and the action on the supplement is expected to be taken by the FDA as soon as possible following the Advisory Committee meeting.
“Endo believes in the ability of OPANA® ER to continue making a difference in the lives of appropriate patients,” said Sue Hall, Ph.D., Executive Vice President, Chief Scientific Officer and Global Head of Research & Development and Quality at Endo. “Endo has been a long standing leader in treating pain and we are working to advance new options to safely and effectively address the unique needs of the pain patient community.”
OPANA® ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatment options are inadequate. The sNDA for OPANA® ER, which is formulated using INTAC® Technology, includes studies designed to evaluate the abuse deterrence of the formulation. INTAC® Technology increases tablet hardness using a high molecular weight polymer (polyethylene oxide). (Original Source)
Shares of Endo International closed yesterday at $17.13, up $0.45 or 2.70%. ENDP has a 1-year high of $88.54 and a 1-year low of $12.56. The stock’s 50-day moving average is $18.62 and its 200-day moving average is $39.84.
On the ratings front, Endo has been the subject of a number of recent research reports. In a report issued on June 13, Mizuho analyst Irina Rivkind Koffler upgraded ENDP to Hold, with a price target of $16, which reflects a potential downside of -6.6% from last closing price. Separately, on the same day, Deutsche Bank’s Gregg Gilbert reiterated a Buy rating on the stock and has a price target of $31.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Irina Rivkind Koffler and Gregg Gilbert have a total average return of 26.1% and -3.6% respectively. Koffler has a success rate of 56.7% and is ranked #13 out of 3878 analysts, while Gilbert has a success rate of 44.6% and is ranked #3389.
The street is mostly Neutral on ENDP stock. Out of 13 analysts who cover the stock, 9 suggest a Hold rating and 4 recommend to Buy the stock. The 12-month average price target assigned to the stock is $22.25, which represents a potential upside of 29.9% from where the stock is currently trading.
Endo International Plc operates as a pharmaceutical company. It focuses on developing, manufacturing, and distributing of branded and generic pharmaceutical products. The company was founded on October 31, 2013 and is headquartered Dublin, Ireland.