Eagle Pharmaceuticals Inc. (NASDAQ: EGRX) shares were in free fall early Friday following a letter from the U.S. Food and Drug Administration (FDA) requesting more information. The company announced that it has received a Complete Response Letter from the FDA for its Kangio (bivalirudin injection), 505(b) New Drug Application (NDA) for a ready-to-use (RTU), stable liquid intravenous formulation of bivalirudin intended for use as an anticoagulant in patients.
Along with this FDA decision, 24/7 Wall St. has listed five key FDA decisions expected by the end of March, as well as an additional four more FDA decisions also expected this month.
The patients are undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIIa inhibitor, undergoing PCI with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome, and/or with unstable angina undergoing percutaneous transluminal coronary angioplasty.
It is worth noting that the FDA issues Complete Response Letters to communicate that their initial review of an application is complete. At the same time, the FDA cannot approve the application in its present form and requests additional information.
In its letter to Eagle, the FDA requested further characterization of bivalirudin-related substances in the drug product. Eagle will work directly with the FDA to determine an appropriate path forward to address the comments.
Scott Tarriff, president and CEO of Eagle, commented:
We are evaluating the FDA’s response and will work closely with the agency to better understand and address their comments regarding Kangio. We remain committed to Kangio as an important new formulation of bivalirudin for intravenous use, offering multiple benefits for patients and care givers.
So far in 2016, Eagle has underperformed the broad markets, with the stock down about 40% (prior to Friday’s move). Over the past 52 weeks, the stock is actually up about 27%.
Shares of Eagle Pharma were down 21.8% to $41.95 Friday morning, with a consensus analyst price target of $99.50 and a 52-week trading range of $36.75 to $104.17.
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Latest from 24/7
