E Shares Of Clovis Dip 70% After Announcing Delay In NDA Process

Shares of Clovis Oncology (CLVS) fell almost 70% today after it announced a delay in its NDA process for the company’s lung cancer drug as rociletinib. The company had already completed a phase 3 trial. The stock tanked because the FDA noticed that the response rate among patients was lower than anticipated in the original NDA filed in September. The FDA is requesting more efficacy data at two dosage levels.

 If all had gone well, the drug was expected to launch by the first quarter of 2016. Now it will be pushed back quite a bit until the FDA’s questions can be addressed properly. This comes at a bad time as biotech stocks have been struggling the past few months. 

Investors were not happy with the delay and that was seen by the huge drop in share price today. Another problem is that a rival drug by AstraZeneca (AZN), known as Tagrisso, was approved by the FDA last week. This bad news today doesn’t help Clovis at all. I would avoid the stock for a few days as it could potentially drop more as other investors digest the news.