See feature article below: Clovis Oncology Inc (NASDAQ: CLVS)
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Next PDUFA Date 06/28/2016
BOULDER, Colo. – Clovis Oncology (CLVS) is facing a federal probe over data regarding its cancer drug, rociletinib. The probe centers on an announcement the company made last year that data showed a reduced rate of complete tumor responses.
In its 10-Q filing with the U.S. Securities and Exchange Commission, Clovis said both immature confirmed and unconfirmed response analyses were submitted to federal regulators. In its filing though, Clovis did not specify which federal body was involved in the probe. In the filing, Clovis said it was cooperating with the inquiries.
In November, Clovis announced that it used interim data about the efficacy of rociletinib publicly and at medical meetings. In its New Drug Application with the U.S. Food and Drug Administration , Clovis said it also used the interim data.
“As the efficacy data have matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected,” Clovis said in November.
The FDA asked Clovis to submit additional data about its efficacy. Clovis had expecting the FDA to rule on rociletinib sometime earlier this year, but the data request pushed that back to April, when ultimately an FDA panel recommended against giving rociletinib an accelerated approval. More recently, Clovis said it met with the FDA and was told it would receive a Complete Response Letter regarding the drug on or before the June 28 deadline for the regulatory agency to rule on a new drug. A Complete Response Letter is issued by the FDA to notify a company that its new drug is not ready for approval.
As a result of the Complete Response Letter, Colorado-based Clovis said it was stopping enrollment in all ongoing sponsored clinical studies of rociletinib. However, the company did say it would continue to provide the drug to patients whose clinicians recommend continuing rociletinib therapy. Based on the Complete Response Letter, Clovis said it was also withdrawing its request for regulatory approval of rociletinib by the European Medicines Agency.
Since November, Clovis stock has bottomed out, dropping from $106.20 per share to today’s price of $12.35 per share. Zack’s Investment Research lowered its rating of Clovis stock from a buy to a hold earlier this month.
With the termination of rociletinib, Clovis announced earlier this month that it will reduce its workforce by 35 percent, including full-time employees as well as contractors. Clovis said it will also halt any planned hiring activities. The terminations are expected to be complete by the end of the year.
The loss of the rociletinib program is a huge blow to Clovis, which does not have any approved products. Rociletinib was the lead drug candidate in the company pipeline.
Not only is the company facing a federal probe, a Colorado law firm, the Shuman Law Firm, announced that it too had launched an investigation into Clovis about whether members of the company’s leadership “breached their fiduciary duties to the company by allegedly causing the Company to issue materially false and misleading statements regarding rociletinib.”
Several shareholders have filed complaints with the company over the cancer drug data. In its 10-Q filing, Clovis highlighted more than a dozen complaints against the company.
Source – Bio Space & BioPharma Catalyst
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