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CLVS

Clovis

$35.77

-1.51 (-4.05%)

08:46
10/07/16
10/07
08:46
10/07/16
08:46

Clovis presents efficacy, safety data from NDA population for rucaparib at ESMO

Clovis Oncology announced the oral presentation of the primary efficacy and safety data from its NDA dataset for rucaparib at the 2016 ESMO Congress in Copenhagen. Rucaparib is currently under priority review with FDA for the monotherapy treatment of advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations who have been treated with two or more chemotherapies, and the submission has a PDUFA date of February 23, 2017. Rucaparib is the Company's oral, small molecule inhibitor of PARP1, PARP2 and PARP3 currently being developed for the treatment of ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, including those with high genomic loss of heterozygosity also known as "BRCA-like." The current NDA submission seeks approval in patients with tumor BRCA mutations, which includes both germline and somatic mutations. These results demonstrate that rucaparib may represent an important option for women with multiply relapsed BRCA-mutated ovarian cancer based on its encouraging efficacy and tolerability," said Rebecca S. Kristeleit, MD, PhD, The University College London, Cancer Institute, London, UK. "In my opinion, rucaparib has the hallmarks of an important new therapeutic option for ovarian cancer patients." "We are pleased to present the primary efficacy and safety dataset that has been submitted to the FDA as the basis of our NDA for rucaparib in the treatment of advanced ovarian cancer. If approved, rucaparib would be the first PARP inhibitor in the U.S. indicated to treat ovarian cancer patients with germline or somatic BRCA mutations who have received two prior chemotherapies. Women with BRCA mutations represent about 25% of patients in the US living with ovarian cancer," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "Our NDA review is ongoing with FDA, and in addition we are actively preparing for a European submission during the fourth quarter of 2016."

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CLVS Clovis
$35.77

-1.51 (-4.05%)

09/21/16
09/21/16
UPGRADE

On The Fly: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Monsanto (MON) upgraded to Overweight from Neutral at JPMorgan with analyst Jeffrey Zekauskas saying the risk in the shares is "less than what the market assumes." 2. Barclays (BCS) upgraded to Buy from Hold at HSBC citing the pending disposal of non-core businesses and resulting value creation. 3. Etsy (ETSY) upgraded to Buy from Neutral at Monness Crespi with the firm's analyst believing that Etsy shares can still move higher and sees a solid opportunity for upward revisions from improving conversion rates due to enhanced search and mobile functionality, expanding take rates, and advanced cross-boarder commerce capabilities with vendors. 4. Clovis (CLVS) upgraded to Outperform from Neutral at Credit Suisse with analyst Kennen MacKay saying the potential for a takeover "outweighs concerns surrounding patent life, limited experience in platinum resistant/refractory patients, and PARPi competition." 5. Jabil Circuit (JBL) upgraded to Buy from Neutral at UBS with analyst Steven Milunovich saying the company's cash flow is nearing an inflection amid an upturn in its Apple (AAPL) business. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
09/21/16
JANY
09/21/16
DOWNGRADE
JANY
Neutral
Clovis downgraded to Neutral from Buy at Janney Capital
09/21/16
JANY
09/21/16
DOWNGRADE
Target $36
JANY
Neutral
Janney downgrades Clovis with buyout speculation at 'fever pitch'
Janney Capital analyst Roy Buchanan downgraded Clovis Oncology (CLVS) to Neutral from Buy with an increased fair value estimate of $36. Clovis is up 17c to $35.00 in late morning trading. In a research note partially titled, "May Be Right, May Be Crazy - M&A Speculation At Fever Pitch," Buchanan says there is a "finite chance" that Clovis will need to market its PARP inhibitor rucaparib by itself. He believes a late-2016 approval for rucaparib is likely. The analyst attributes his increased fair value estimate to "acquisition optionality." Reports of Takeda's (TKPYY) reserving up to $15B for acquisitions and Medivation's (MDVN) takeout have given Clovis shares a lift, Buchanan tells investors. The analyst adds that rumors surfaced yesterday of potential interest in the company from Eli Lilly (LLY).
10/04/16
PIPR
10/04/16
NO CHANGE
Target $42
PIPR
Neutral
Clovis price target raised to $42 from $14 at Piper Jaffray
Piper Jaffray analyst Steven Breazzano raised his price target for Clovis Oncology (CLVS) to $42 after taking a "comprehensive look" at the PARP inhibitor landscape in ovarian cancer and beyond. The company's PARP inhibitor rucaparib has demonstrated an active profile in ovarian cancer and all signs point to an approval in the 3L+ setting early next year, Breazzano tells investors in a research note. The analyst, however, believes the ultimate key is success in the earlier maintenance setting, and he thinks the race may still be Tesaro's (TSRO) niraparib's to lose. Breazzano keeps a Neutral rating on Clovis.

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