Clovis Oncology Inc’s lead asset rucaparib has a poor risk-benefit profile. The candidate’s lack of efficacy over current treatments and safety signals represent “considerable risks” ahead of its PDUFA in February next year, Chardan Capital Markets’ Madhu Kumar said in a report. He initiated coverage of the company with a Sell rating and a price target of $15.
The new drug application [NDA] of Clovis Oncology’s rucaparib for the third-line treatment of ovarian cancers is under priority review by the FDA and has a Prescription Drug User Fee Act [PDUFA] date of February 23, 2017. Kumar believes that the drug will not achieve accelerated approval.
- Efficacy: “Rucaparib does not appear to show a clinical benefit over existing therapies,” Kumar wrote.
- Safety: Rucaparib has exhibited multiple higher adverse events as compared to the already approved ovarian cancer drugs.
- Another failure: Another drug candidate rociletinib has recently met with regulatory failure. Pointing out that there are “striking parallels between rucaparib and rociletinib,” the analyst expressed concern over Clovis Oncology’s “ability to achieve regulatory approval on preliminary data in the absence of randomized trials.” He added that the NDA failure represented “additional worrying management signal.”
With approval being potentially delayed until phase III results, along with limited patent life, further limits upside, Kumar noted.