Stifel Updates on Clovis Oncology (CLVS) Ahead of Expected Rucaparib NDA Response; affirms 'Buy' Rating

August 18, 2016 6:27 AM EDT
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Stifel affirms Clovis Oncology (Nasdaq: CLVS) with Buy rating and $30 price target, offering up a update on rucaparib NDA.

The firm commented, Clovis expects a response from the FDA on about August 22nd for the rolling NDA for rucaparib in the treatment setting. The company has so far released data from best-case patients with Pt-sensitive disease and response rates range from about 60% (three prior treatment lines) to about 80% (fewer prior lines) – and these numbers compare favorably with the response rates for olaparib in similar patients (46%). The NDA will also have treatment data from Pt-resistant patients and these rates are expected to be much lower.

Based on management comments, we estimate these rates to be about 35% in platinum-resistant BRCA patients – again higher than olaparib. As a result, the overall response rate in the NDA submission is relatively unimportant and will mostly reflect patient mix. In addition, the response rate will be different depending on whether Clovis is seeking approval for 2 or more lines of therapy of 3 or more lines of therapy – but these differences won’t be particularly meaningful (see below). As a result, the most important feature of the Clovis data release will be safety and a continued low rate of secondary tumors, particularly MDS, would be a significant positive.

For an analyst ratings summary and ratings history on Clovis Oncology click here. For more ratings news on Clovis Oncology click here.



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