Endo International plc – Ordinary Shares (NASDAQ:ENDP) announced that based on an August 11, 2016 discussion with the U.S. Food and Drug Administration (FDA), the Company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for OPANA® ER without prejudice to re-filing. The Company plans to continue collecting and analyzing epidemiological data relating to OPANA® ER. Endo’s financial projections for 2016 did not assume approval of the sNDA.
“We anticipate the generation of additional data and we will seek collaboration with FDA to appropriately advance OPANA® ER,” said Sue Hall, Ph.D., Executive Vice President, Chief Scientific Officer and Global Head of Research & Development and Quality at Endo. “We believe in the ability of OPANA® ER to continue making a difference in the lives of appropriate patients and remain committed to safely and effectively addressing the 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, included 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 are up nearly 2% to $23.42 in pre-market trading. ENDP has a 1-year high of $86.72 and a 1-year low of $12.56. The stock’s 50-day moving average is $17.43 and its 200-day moving average is $28.27.
On the ratings front, Endo has been the subject of a number of recent research reports. In a report issued on August 9, J.P. Morgan analyst Chris Schott reiterated a Buy rating on ENDP, with a price target of $40, which represents a potential upside of 73.8% from where the stock is currently trading. Separately, on the same day, Leerink Swann’s Jason Gerberry reiterated a Hold rating on the stock and has a price target of $22.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Chris Schott and Jason Gerberry have a total average return of 0.0% and -0.7% respectively. Schott has a success rate of 55.3% and is ranked #2741 out of 4110 analysts, while Gerberry has a success rate of 51.9% and is ranked #3024.
The street is mostly Neutral on ENDP stock. Out of 12 analysts who cover the stock, 7 suggest a Hold rating and 5 recommend to Buy the stock. The 12-month average price target assigned to the stock is $28.71, which implies an upside of 24.8% from current levels.
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.