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Clovis' (CLVS) Rociletinib to Face FDA Advisory Panel in April

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Clovis Oncology, Inc.CLVS announced that the new drug application (NDA) for its lead pipeline candidate, rociletinib, is scheduled to be reviewed by the FDA's Oncologic Drugs Advisory Committee (ODAC) on Apr 12, 2016. The company's shares were up almost 2% on the news.

We note that the ODAC reviews and evaluates data related to the safety and effectiveness of marketed and investigational human drug products to be used for the treatment of cancer, and thereby makes recommendations to the FDA.

Clovis is looking to get rociletinib approved in the U.S. for the treatment of patients with mutant EGFR non-small cell lung cancer, who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation. The candidate is also under review in the EU for the same indication.

We note that Clovis' shares have been taking a beating since Nov 2015 when the FDA had asked for additional data for analyzing the efficacy of rociletinib. The company submitted a major amendment to the NDA in the same month, which pushed the FDA action date forrociletinib further by three months to Jun 28, 2016, from the earlier date of Mar 30, 2016.

Given that Clovis has no approved product in its portfolio at the moment, and rociletinib is the company's lead pipeline candidate, investor focus is expected to remain on the outcome of the advisory panel meeting and approval status of the candidate.

Clovis is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK , Ligand Pharmaceuticals Incorporated LGND and Horizon Pharma plc HZNP . All three stocks sport a Zacks Rank #1 (Strong Buy).

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ANIKA THERAPEUT (ANIK): Free Stock Analysis Report

LIGAND PHARMA-B (LGND): Free Stock Analysis Report

HORIZON PHARMA (HZNP): Free Stock Analysis Report

CLOVIS ONCOLOGY (CLVS): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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