Stifel Affirms Clovis Oncology (CLVS) at 'Buy'; Sees Rucaparib Approval in Q117

August 24, 2016 6:14 AM EDT
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Price: $30.62 --0%

Rating Summary:
    4 Buy, 7 Hold, 1 Sell

Rating Trend: = Flat

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    Up: 3 | Down: 10 | New: 2
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Stifel affirms Clovis Oncology (Nasdaq: CLVS) with a Buy rating and $30 price target after the company announced that the U.S. Food and Drug Administration (FDA) has accepted Clovis’ New Drug Application (NDA) for accelerated approval of rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of February 23, 2017.

Analyst Thomas Shrader said, Overall, these data look good enough for approval and the drug has a PDUFA date of February 23, 2017. Few new details were included in the release concerning the efficacy of the drug in Pt-resistant patients. These details are likely being saved for upcoming presentations at ESMO 2016.

Shrader also expects approval in Q117, commenting, The FDA has now accepted Clovis’ NDA submission, granted the application priority review status, and assigned a PDUFA date of February 23, 2017. We believe the BRCA-mutant response rate of 54% and median DoR of 9.2 months (median prior number of therapies = 3), along with a favorable safety/tolerability profile, should satisfy the requirements for FDA approval. Although patient mix remains unknown, these data seem better than those reported for olaparib. In a similar setting, olaparib’s label lists a response rate of 34% and a median duration of response of 7.9 months. We note olaparib was approved in December 2014 and is currently on about a $200 million annualized run rate for FY16 sales.

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