CLOVIS ONCOLOGY Forum: Community User: Maroni

PDUFA date set for Feb 23

FDA Accepts New Drug Application For Rucaparib For Priority Review For The Treatment Of Advanced Mutant BRCA Ovarian…

:(((

Mal nicht übertreiben ;-)

40 wären schön;)

kann nur leider alles nur überfliegen..wenig Zeit

Das geht noch ab hier;)

Sieht gut aus momentan.. Pre Market in US +1,5%

nicht dass es wieder kommt Sell on Good News;(

Na dann schauen wir doch mal gespannt, was da am 22.8. passiert :)

Clovis Oncology believes that accelerated approval might be on the cards Published By: Eunice Gettys on August 18, 2016 11:08 am EST 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.

Zacks Investment Research upgraded shares of Clovis Oncology Inc. (NASDAQ:CLVS) from a hold rating to a buy rating in a research note released on Thursday morning. Zacks Investment Research currently has $18.00 target price on the biopharmaceutical company’s stock. According to Zacks, “Clovis’ second quarter loss was narrower-than-expected. We are encouraged by the company's progress with its lead pipeline candidate, rucaparib. The company has submitted a rolling NDA for the candidate and is on track to file for EU approval in the fourth quarter of 2016. Approval would be a huge boost for the company given the immense commercial potential in the target market and the demand for PARP inhibitors. However, we remain concerned about Clovis’ dependence on just one candidate. The company has already suffered a huge setback on the regulatory front when it was informed by the FDA that the agency would issue a complete response letter for rociletinib. Based on this, the company decided to discontinue investment in rociletinib. Any further regulatory or pipeline setback would weigh heavily on the stock.”

Angeblich haben die “Baker Brothers Advisors“ jetzt 51.3Million $ an Aktien... Und “Palo Alto Investors“ haben auch aufgestockt..

HealthCor Management, L.P. files portfolio update HealthCor Management, L.P. just filed a portfolio update (also known as a 13-F), dated August 15, 2016. The portfolio holdings are as of June 30, 2016. HealthCor Management, L.P. reported adding to its positions of:Aetna Inc.Clovis OncologyCOLLEGIUM PHARMACEUTICAL, INCConatus PharmaceuticalsEdwards Lifesciences CorporationHealthSouth CorporationPRA Health Sciences, Inc.Neurocrine BiosciencesNatera, Inc.Labor Smart, Inc.ICON plcHumana Inc. Positions in the following companies appear to have been reduced: AkornBristol-Myers Squibb CompanyDex One CorporationHCA HoldingsZimmer HoldingsWaters Corporat ionUniversal Health ServicesThermo Fisher Scientific IncQuest Management Inc.INC Research Holdings, Inc.

Up up....

Formycon weiterhin.. Und ansonsten nur noch kleine Werte, bei denen ich aber bös im Minus bin..