GPC Biotech's Prostrate Cancer Drug Hits Approval Delay
Posted on: Thursday, 26 July 2007, 12:24 CDT
GPC Biotech's shares fell by around 33% after an advisory panel in the US said that regulators should wait for more data before deciding to approve the company's prostrate cancer drug.
GPC Biotech's market value has plummeted nearly E180 million ($247 million) because of the panel's vote against its Orplatna drug.
Although the company said that it does have sufficient cash to get to the survival endpoint, it does not expect to have an analysis from the 950-patient study for another year.
The drug, which is the company's lead product candidate, is designed for prostrate cancer patients who no longer respond to chemotherapy or hormone treatments.
The FDA is expected to come to a final decision by mid-August 2007.
Source: Datamonitor
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