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CLVS

Clovis

$70.61

1.85 (2.69%)

06:02
09/13/17
09/13
06:02
09/13/17
06:02

Clovis: Phase 3 ARIEL3 study of rucaparib met primary, key secondary endpoints

Clovis Oncology announced that comprehensive data from the Phase 3 ARIEL3 study of rucaparib for maintenance treatment of advanced ovarian cancer were published online in The Lancet. The ARIEL3 study successfully achieved its primary and key secondary endpoints - improved progression-free survival by both investigator review and blinded independent central review, respectively - in each of the three populations studied, as well as its exploratory endpoints. ARIEL3 is a double-blind, placebo-controlled, phase 3 trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) tumor BRCA mutant patients, inclusive of germline and somatic mutations of BRCA (n=196); 2) HRD patients, including BRCA-mutant patients and BRCA wild-type with high loss of heterozygosity, or LOH-high patients (n=354), and, finally, 3) the intent-to-treat population, or all patients treated in ARIEL3 (n=564). The study achieved its primary endpoint of improved PFS by investigator review in each of three populations. PFS was also improved in the rucaparib group compared with placebo by BICR, a key secondary endpoint, in all three populations. In addition, rucaparib improved objective response rate vs placebo among evaluable trial participants in all three study populations. According to the paper, treatment emergent adverse events in the ARIEL3 rucaparib group were generally managed with dose modifications and not associated with increased mortality or morbidity compared with the placebo group. Safety data from ARIEL3 demonstrate consistency with prior rucaparib studies. Based on the ARIEL3 findings, Clovis Oncology plans to submit a supplemental New Drug Application to the U.S. FDA for a second line or later maintenance treatment indication in ovarian cancer by the end of October 2017. In early 2018, the Company plans to file an MAA in Europe for the maintenance treatment indication upon receipt of a potential approval for the treatment indication.

CLVS Clovis
$70.61

1.85 (2.69%)

08/18/17
SBSH
08/18/17
NO CHANGE
Target $216
SBSH
Buy
Citi sees advantage for Tesaro despite broad Lynparza label
Citi analyst Robyn Karnauskas says the "broad label" given yesterday to AstraZeneca's (AZN) Lynparza increases competition for Tesaro (TSRO). Lynparza got a broad label in all ovarian cancer patients, which Karnauskas says she was not modeling for. The analyst suspects Clovis Oncology (CLVS) could also get a similar broad label. Nonetheless, she believes that with "better clinical data, better value, and dosing convenience," Tesaro's Zejula has a potential marketing advantage. Oncologic drugs with the best outcomes data eventually emerge market winners, Karnauskas tells investors in a research note. The analyst keeps a Buy rating on Tesaro with a $216 price target. The shares closed yesterday down $3.94 to $109.05.
08/18/17
LEER
08/18/17
NO CHANGE
Target $107
LEER
Outperform
Clovis price target lowered to $107 from $115 at Leerink
Leerink analyst Michael Schmidt lowered his price target for Clovis Oncology (CLVS) to $107 after competitor AstraZeneca (AZN) received a broad label for PARP inhibitor Lynparza as maintenance treatment following second line ovarian cancer therapy regardless of BRCA status. His new target reflects a three-way market split among Clovis' Rubraca, Tesaro's (TSRO) Zejula and Lynparza in second line ovarian cancer maintenance. The analyst, however, believes Clovis remains attractively valued and he keeps an Outperform rating on the shares.
09/06/17
JPMS
09/06/17
NO CHANGE
Target $111
JPMS
Overweight
JPMorgan reiterates Overweight on Clovis ahead of data
JPMorgan analyst Cory Kasimov reiterates an Overweight rating on shares of Clovis Oncology ahead of the full ARIEL 3 data on Friday at ESMO in Madrid. Since Clovis already provided a significant amount of detail, the analyst expects the full data set to be "robust, albeit somewhat incremental overall." Kasimov continues to see "significant strategic value" in Clovis and keeps a $111 price target on the shares.
09/11/17
MSCO
09/11/17
NO CHANGE
MSCO
Overweight
Tesaro, Clovis pressured as by IO synergy questions, says Morgan Stanley
Morgan Stanley analyst Andrew Berens noted selloffs on Friday in shares of both Tesaro (TSRO) and Clovis (CLVS), which he attributed to investors questioning their drug's synergies with IO after the TOPACIO trial data on Tesaro's Zejula raised questions about treatment duration. Also, some investors view the current response rates as raising questions about the utility of combination strategies, said Berens. However, he is encouraged that triple negative breast cancer patients with WT BRCA seemed to respond to Zejula, which he believes could open up a much larger breast cancer opportunity than is currently modeled. Berens has Overweight ratings on Tesaro and Clovis shares.

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AMZN

Amazon.com

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GOOGL

Alphabet Class A

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MOH

Molina Healthcare

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UnitedHealth

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WCG

WellCare

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ANTM

Anthem

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Aetna

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SAP

SAP

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TAT Technologies

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Boeing

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GM

General Motors

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Wells Fargo

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EADSY

Airbus

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Quest Diagnostics

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IRBT

iRobot

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Xilinx

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Synopsys

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UTX

United Technologies

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Rockwell Collins

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Honda

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ONCE

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RGNX

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CI

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MOH

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AOBC

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MSFT

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GOOGL

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FB

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AVA

Avista

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0.1 (0.19%)

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BMWYY

BMW

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0.083 (0.24%)

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BMW to build new 8 series in Dingolfing from 2018, Reuters reports »

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Cisco

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0.67 (2.05%)

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Cisco completes acquisition of Springpath »

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