Austin biotech startup XBiotech finally got an answer from European regulatory officials about whether it can sell and market its lead cancer drug, Xilonix, in Europe.
The answer was no.
The company said in a written statement that it plans to request a “re-examination and will have 60 days to submit its grounds for appeal.” The company said it believes it has a “strong position for re-examination.”
This wasn’t exactly a surprise. During XBiotech’s quarterly conference call on May 10, CEO John Simard explained that when the company met with the EMA in April, a “trending vote” was taken that indicated there was a lack of support for approval. This week’s announcement was the formal decision.
After that meeting in April, XBiotech’s stock dropped 40 percent, from about $17 a share to $10 a share. On Friday morning it was hovering around $8.60 a share.
XBiotech is focused on treating diseases by identifying antibodies found in people, and then cloning these antibodies for mass production.
Its lead drug, Xilonix, is aimed at treating colorectal cancer by attacking inflammation.
But there has been some controversy over how XBiotech approached its European clinical trials. XBiotech measured symptoms associated with disease progression, such as pain, fatigue and muscle loss.
The company did not use more conventional measures of drug success, such as tumor growth.
Though gaining European approval is important to XBiotech’s survival, the company has other drugs in its development pipeline and is conducting clinical trials in the U.S. for Xilonix.
Simard said during his company’s most recent earnings conference call that XBiotech is conducting a globaly Phase 3 study for Xilonix under a fast-tracked FDA regulatory path. That study is intended to measure overall survival.
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