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Clovis Oncology Inc (CLVS) New Drug Application For Rucaparib Receives Positive Response

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Clovis Oncology believes that accelerated approval might be on the cards

Stifel believes that the response by the Federal Drug Authority regarding the new drug application by Clovis Oncology Inc (NASDAQ:CLVS) is very positive and the drug might enter the clinical trial phase sooner than expected. The American drug regulatory authority, namely FDA, is expected to respond regarding Rucaparib on Monday, August 22.

According to the analyst, Clovis Oncology has thus far only presented data relating to best case scenarios in which patients with Prothrombin time sensitive disease showed encouraging responses. The data suggests that the positive response rates in these patients were found to be between 60% to 80%. Comparing these results with Olaparib data makes a very strong case in favor of Rucaparib, as the response rate for Olaparib in similar setting was only 46%. The study will, however, include data for Prothrombin resistant patients, the response rates for which are expected to be far lower, but it will be interesting to see if they are still above the Olaparib.  

According to the recent comments made by the management, the analyst expects the response rate for platinum resistant BRCA patients to be around 35%, which is still significantly higher than Olaparib. The response rates are expected to vary and will depend on the company’s management that whether they will apply for “2 or higher lines of therapy” or “3 or higher lines of therapy”.

Stifel analyst believes that the most important part will be the data regarding the emergence of secondary tumors following the treatment. The data thus far has shown positive results and can be a huge positive for the company. The analyst reaffirmed Buy rating and a price target of $30. The analyst ratings for CLVS have 2 Buy, 1 Outperform and 6 Hold ratings. The stock now trades at a price of $17.05.

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