Get Stock Quote Here Clovis Oncology (CLVS) is a small pharmaceutical company which mainly markets products for treatment in oncology. Depomed was founded in 2009 and is headquartered in Dover, Colorado. The company is a publicly traded company on NASDAQ under the symbol CLVS and is in the NASDAQ Biotechnology Index with several products in its product pipeline.
Clovis Oncology (CLVS) Approval Less Likely But Possible Mizuho analyst, Eric Criscuolo, thinks the FDA's briefing documents for Clovis Oncology's (NASDAQ: CLVS) April 12 rociletinib AdComm meeting raised numerous issues and concerns for the drug's approval. "It's ugly, but we think the drug could still get approved". No change to Neutral rating or $21 PT. The FDA voiced its displeasure over the handling of efficacy data, dose reductions, and recommends a Boxed Warning for QTc. The FDA is asking its advisory panel to vote on one question: "Should the results of the randomized clinical trial (TIGER-3) be submitted before FDA makes a regulatory decision on this application?" TIGER-3 is comparing rociletinib versus chemotherapy, potentially a 2018 event, meaning approval could be a few years away. The FDA highlighted a few key questions: 1) Is the activity of rociletinib reasonably likely to predict clinical benefit and superior to available therapy? 2) Is the recommended dose of 625 mg BID supported by the data? 3) Are the risks (particularly QTc) acceptable? 4) Has the dose modification strategy to been adequately characterized? FDA raised concerns about all of these areas. Shares of Clovis Oncology closed at $19.17 yesterday.
Massive move and +30% close!!! Clovis shares jump as FDA grants priority review to cancer treatment http://www.marketwatch.com/story/cl...priority-review-to-cancer-tratment-2016-08-23 Clovis Oncology Inc. CLVS, +27.24% shares ticked higher after hours Tuesday following a big jump in the regular session as the Food and Drug Administration accepted a marketing application for the company's ovarian cancer treatment and granted it a priority review process. Clovis shares advanced 1% to $23.25 after hours, following a 23% rally in the regular session. The FDA is expected to make a decision on the application by Feb. 23, 2017. Studies of Clovis's treatment rucaparib showed 54% of patients with recurring ovarian cancer responded to the treatment.
I swear there are two biotech movers like this each day for the past week! Which one will run tomorrow?
Credit Suisse analyst: $CLVS could be worth $35-$41 per share on operational synergies, and $52-$55 per share with leveraged tax benefits.
Looks like there were some deaths in some of the patients: Clovis Oncology Inc (NASDAQ:CLVS) investors are heading for the hills after the cancer drug maker announced the oral presentation of the primary efficacy and safety data from its NDA dataset for rucaparib, a third-line treatment of ovarian cancer patients with BRCA-mutated tumors, at the 2016 ESMO Congress in Copenhagen. On the negative side, the company disclosed that nine patients had adverse events that led to death, of which 8 were due to disease progression. http://www.smarteranalyst.com/2016/...-heres-clovis-oncology-inc-shares-falling-28/
Analyst Upgrade/Downgrade Update Brokerage firm: Chardan Capital Mkts Change: Coverage Initiated Previous Rating: N/A Current Rating: Sell Previous Price Target: N/A Current Price Target: $15
$CLVS LOL, another wave of buying.... new high. AgAIN. Poor shorts... http://shortsqueeze.com/?symbol=clvs&submit=Short+Quote™
Very predictable with no Monday BO. This will flounder a couple points here and there. The by end of week, new high. Go long for 120+
