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March 26, 2014
10:06 EDTCLVSClovis advances ahead of clinical trial update
Shares of Clovis (CLVS) are rising a day before the company is slated to report interim results from a study of its CO-1686 drug. CO-1686 is supposed to treat non-small cell lung cancer. WHAT'S NOTABLE: In a regulatory filing on February 27, Clovis said that it would provide an update on clinical results from a Phase I study of CO-1686. The update will include results from patients treated with the hydrobromide salt formulation that will be used in all clinical studies going forward, the company stated. The results are slated to be presented during a session that will be held between 10 am ET and 11:30 am ET, Clovis reported. CO-1686 is supposed to mutant forms of the epidermal growth factor receptor and the T790M resistance mutation. ANALYST REACTION: In a note to investors earlier today, Leerink Swann analyst Mark Kozul estimated that there is about an 85% chance that the stock will rise following tomorrow's update. The stock could jump more than $15-$20 if the data lowers CO-1686's risk, he predicted. Moreover, there is less than a 15% chance that the stock will drop following the update, and the shares are unlikely to decline more than $10, the analyst predicted. Kozul reiterated a $110 price target and Outperform rating on the stock. PRICE ACTION: In early trading, Clovis climbed $3.70, or 5%, to $77.50.
News For CLVS From The Last 14 Days
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July 2, 2015
10:38 EDTCLVSFly Watch: Biotech sector events to watch for this summer
Three key events in the biotech sector are slated to occur this summer, Mizuho Securities previewed in a note to investors today. Namely, data from Clovis Oncology's (CLVS) lung cancer treatment is expected to be released, interim data for Verastem's (VSTM) cancer treatment could be unveiled and the PDUFA date for Tesaro's (TSO) rolapitant drug for chemotherapy-induced nausea and vomiting will occur. A PDUFA date is the day on which the FDA is expected to decide whether to approve a drug. WHAT'S NEW: Data for Clovis' rociletinib lung cancer treatment is expected by the firm to be released September 6-9, Mizuho analyst Peter Lawson wrote. Favorable data could result in the the drug more quickly becoming the first treatment option after it hits the market, the analyst stated. Interim data for Verastem's cancer treatment product, defactinib, will have one of three outcomes, Lawson forecast: additional patients will be enrolled in the study, the study will be terminated due to poor results or the patients in the study with low levels of a tumor suppressor gene product called Merlin will be enriched for Merlin. According to Lawson, expectations heading into the trial are low, and the most likely outcome is that the Merlin enrichment scenario will occur. If this scenario does occur, Verastem's stock will probably temporarily fall, potentially creating a better entry point, Lawson believes. The PDUFA date for Tesaro's rolapitant drug is September 5, the analyst stated. The analyst kept a $103 price target and Buy rating on Clovis, a $67 price target and Buy rating on Tesaro and a $21 price target and Buy rating on Verastem. PRICE ACTION In early trading, Clovis fell 2.2% to $83.98, Verastem retreated 2.3% to $6.96 and Tesaro dropped 1.7% to $55.80.
July 1, 2015
16:07 EDTCLVSClovis initiates rolling NDA submission to FDA for Rociletinib
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June 22, 2015
08:03 EDTCLVSClovis names Dr. Lindsey Rolfe as Chief Medical Officer
Clovis Oncology announced that Dr. Lindsey Rolfe, BSc, MB ChB, MRCP, FFPM, has been named Chief Medical Officer and EVP of Clinical and Preclinical Development and Pharmacovigilance, to become effective in early August. Dr. Rolfe succeeds Dr. Andrew Allen, who will be stepping down from his role at Clovis at that time to create a new immuno-oncology focused biotechnology company and serve as its CEO. Dr. Rolfe joined Clovis in early 2010 and oversees rociletinib and rucaparib development in her current role as SVP of Clinical Development. As Chief Medical Officer at Clovis, Dr. Rolfe will be responsible for clinical development, preclinical development, clinical operations and pharmacovigilance and will also serve on the company’s executive committee.

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