ARTICLE | Finance
Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
March 10, 2014 7:00 AM UTC
Endo International plc (NASDAQ:ENDP; TSX:ENL) was off $6.06 to $73.76 last week after FDA approved a resubmitted NDA for Aveed testosterone to treat male hypogonadism. The company said it plans to launch the product this month.
Aveed's label includes a boxed warning on the risk of serious pulmonary oil microembolism reactions and anaphylaxis. Serious pulmonary oil microembolism reactions involve cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness and syncope. In May 2013, FDA issued a complete response letter that requested a REMS due to risks related to post-injection reactions...