Clovis Oncology Inc (NASDAQ: CLVS) is off to an incredibly strong start to the trading session this morning, and for good reason. The company released positive clinical data surrounding rucaparib. Of course, this led to excitement among investors, causing gains and prompting our partners at Trade Ideas to alert us to the movement. At the moment (9:32), CLVS is trading at $89.23 per share after a gain of $29.26 per share or 48.79% thus far today.
CLVS Releases Positive Clinical Data
As mentioned above, Clovis Oncology is having a strong start to the trading session today after releasing positive clinical data. The data came from the confirmatory Phase 3 ARIEL3 trial of rucaparib. According to the press release issued by the company this morning, the trial met its primary endpoint of improving progression free survival, also known as PFS, by investigator review in each of the 3 populations studied.
As a result of the strong clinical data, CLVS intends on submitting a supplemental New Drug Application to the United States Food and Drug Administration. This could happen anytime within the next 4 months. The application will be related to a second-line and later maintenance treatment indicated for all women with platinum-sensitive sensitive ovarian cancer who have responded to their most recent platinum therapy. In a statement, Patrick J. Mahaffy, President and CEO at CLVS, had the following to offer…
“We are very pleased with these positive ARIEL3 topline results that strongly demonstrate the potential of rucaparib to help women with platinum-sensitive, advanced ovarian cancer… These results reinforce the potentially foundational role of rucaparib in the management of advanced ovarian cancer, as demonstrated by both investigator review and the blinded independent central review. Most importantly, we are grateful to the patients, caregivers and investigators who participated in this study. We look forward to sharing these data in greater detail at a medical meeting later this year and submitting our sNDA as rapidly as possible, with the ultimate goal of making rucaparib available to more women battling ovarian cancer.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on CLVS. In particular, we’re interested in following the company through ongoing work surrounding rucaparib, including but not limited to the coming sNDA. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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