Endo shares sink after FDA rejects Aveed NDA
Shares of Endo Pharmaceuticals (ENDP) slid this morning after investors got wind of the news that the FDA stiff-armed the company's application to market its new drug for low testosterone. Low testosterone is associated with a variety of ailments, including fatigue and loss of libido.
Regulators want more information on rare but serious incidents of anaphylactic reactions and pulmonary oil microembolism among patients taking Aveed (known as Nebido outside the U.S.). And the FDA said in its complete response letter that Endo's risk mitigation program for the drug is inadequate. Endo stock was down nine percent in premarket trading.
The FDA's rejection marks a setback for Endo CEO David Holveck, who recently signaled his interest in a new round of deals to help the company expand beyond pain into new therapeutic areas like cancer. Earlier this year Endo bought out Indevus for $370 million, winning Aveed in the deal. Holveck is now looking for new licensing pacts, acquisitions and development deals. In a terse release, the developer says that it's evaluating the FDA's letter.