Egalet Corp (NASDAQ:EGLT) announced yesterday that the FDA had given them notice that they would not be meeting their PDUFA data of Oct 14th for ARYMO ER, EGLT’s proprietary abuse-deterrent, extended-release morphine.
Egalet shares reacted to the news, falling nearly 5% to $7.16 in pre-market trading Friday.
“Today we were informed that the FDA has identified no particular issue with our application for ARYMO ER and that the Agency is working on the product label,” said Bob Radie, president and chief executive officer. “The FDA indicated that they need more time as they have done with other abuse-deterrent opioid NDAs, and confirmed that no additional scientific information or data is needed for our application. We will continue to work closely with the FDA to bring this important product to those living with chronic pain and the healthcare professionals who treat them.”
In a research report issued today, Cantor analyst Chiara Russo noted, “No additional data was asked for which we believe highlights that this is a labeling language issue. FDA PDUFA delays are not uncommon, particularly in the opioid space. For example, Collegium’s Xtampza missed their Oct. 2015 PDUFA date but gained approved 6 months later in April 2016. We do note that if Arymo ER is not approved before June 30, 2017, the company may not receive the additional $40M in financing.”
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Chiara Russo has a yearly average return of 4.9% and a success rate of 52%. Russo is ranked #806 out of 4182 analysts.
Egalet Corp. develops and manufactures pharmaceutical products. It provides pipeline of clinical stage opioid based product candidates that are specifically designed to deter abuse by physical and chemical manipulation. It includes products SPRIX nasal spray and OXAYDO tablets which are used to treat pain.