- Clovis Oncology's stock has tumbled roughly 74% in the last two days, as investors soured on the prospects of its lead drug candidate rociletinib. Not only did the FDA question Clovis' clinical data, but the agency also just approved AstraZeneca's competitor drug, Tagrisso.
- Clovis Oncology (CLVS) has lost $2 billion in market value over the last two days.
- Both WallachBeth Capital and Goldman Sachs downgraded CLVS from a target price range around $130 to as low as $23 to $30.
In early October, Clovis investors were excited about the prospects for rociletinib. The US had granted the drug Priority Review while the European Medicine Association (EMA) had put it in its accelerated assessment program. The competition between rociletinib and AZ's Tagrisso seemed even.
However, Tagrisso was approved early by the FDA in conjunction with a companion diagnostic test. Even worse, Clovis announced the FDA had requested additional clinical trial data in order to examine confirmed responses rates versus unconfirmed rates. Based on the latest analysis, response rates to rociletinib among trial subjects is between 28% to 34%, compared with 59% for Tagrisso treated patients. Rociletinib also had a longer duration of action.
As Targrisso continues to gather steam, Clovis investors appear concerned about the company falling behind.