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NCNA

NuCana

$11.40

-0.4 (-3.39%)

19:25
06/12/19
06/12
19:25
06/12/19
19:25

NuCana says FDA grants orphan drug designation for Acelarin

NuCana announced that the U.S. Food and Drug Administration has granted orphan drug designation for the Company's investigational drug, Acelarin, for the treatment of biliary tract cancer. Acelarin is a new chemical entity and is NuCana's ProTide transformation of gemcitabine. "We are pleased to have received orphan drug designation from the FDA for Acelarin in biliary tract cancer," said Hugh Griffith, NuCana's Founder and Chief Executive Officer. "There is a high unmet need for patients suffering from this cancer type. Our Phase Ib study of Acelarin combined with cisplatin showed an approximate doubling of the response rate expected with the standard of care, gemcitabine plus cisplatin, with several patients achieving significant reductions in their tumor volume as well as further tumor shrinkage over time. We believe Acelarin represents a potential significant advance in biliary tract cancer and we remain on track to open our global Phase III study in combination with cisplatin as a front-line treatment for patients with advanced biliary tract cancer in 2019."

NCNA NuCana
$11.40

-0.4 (-3.39%)

10/18/18
PIPR
10/18/18
INITIATION
Target $36
PIPR
Overweight
NuCana initiated with an Overweight at Piper Jaffray
Piper Jaffray analyst Joseph Catanzaro started NuCana with an Overweight rating and $36 price target, stating that data for its lead product, Acelarin, have "strongly" pointed towards platform validation. He sees an opportunity for the drug in platinum-resistant ovarian cancer and sees the potential for it to "establish a new frontline standard of care in biliary tract cancer," Catanzaro tells investors.
10/21/18
PIPR
10/21/18
NO CHANGE
Target $36
PIPR
Overweight
NuCana updated Phase Ib data positive for acelarin in biliary cancer, says Piper Jaffray
Piper Jaffray analyst Joseph Catanzaro notes that NuCana presented updated Phase Ib data for Acelarin plus cisplatin in 1st-line advanced BTC at ESMO this weekend. An ORR of 50% in 14 patients is consistent with the abstract and continues to suggest a near doubling of standard of care, he adds, highlighting that tumor reductions appear to be durable out to the 36-week assessment and the safety profile is unremarkable compared to gem/cis. The analyst maintains his positive outlook for the planned Phase III trial and the opportunity to establish a new standard of care for this sizable patient population. Catanzaro reiterates an Overweight rating and $36 price target on the shares.
03/10/19
PIPR
03/10/19
NO CHANGE
Target $35
PIPR
Overweight
NuCana shares 'significantly undervalued,' says Piper Jaffray
Piper Jaffray analyst Joseph Catanzaro is "incrementally more positive" around NuCana's "ambitious" development strategy for the ProTide platform after speaking to management. The analyst continues to believe that clinical data presented to date have fully supported ProTide's mechanism of action. Shares of NuCana are "significantly undervalued for the clear blockbuster potential" of NuCana's two lead assets, Catanzaro tells investors in a research note. He maintains an Overweight rating on the shares and trimmed his price target to $35 from $36.
06/02/19
PIPR
06/02/19
NO CHANGE
Target $35
PIPR
Overweight
NuCana pivotal BTC trial on-track to open in 2H19, says Piper Jaffray
Piper Jafrray analyst Joseph Catanzaro notes that NuCana provided a modest update to the Phase Ib studies looking at Acelarin in combination with platinum chemotherapy in ovarian and biliary tract cancer at ASCO with data largely consistent with prior updates. Enrollment into the pivotal Phase III BTC trial to evaluate Acelarin plus cisplatin is expected to begin in early 2H19, with final FDA sign-off on the protocol expected in the coming weeks, he notes. Catanzaro continues to believe that clinical data presented to date have fully supported Acelarin and the ProTide platform, and that Acelarin is well-positioned to establish a new standard of care in BTC. He reiterates an Overweight rating and $35 price target on the shares.

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BMY

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LN

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FXI

iShares China Large-Cap ETF

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PAVM

PAVmed

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LN

Line Corp.

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DBX

Dropbox

$25.29

0.3 (1.20%)

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AMZN

Amazon.com

$1,906.00

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Ulta Beauty

$354.70

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AEGN

Aegion

$16.86

0.17 (1.02%)

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10:37
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Dallas Fed Mfg Survey General Activity Index data reported »

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NOW

ServiceNow

$282.05

-3.7 (-1.29%)

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BHVN

Biohaven Pharmaceutical

$40.80

-0.26 (-0.63%)

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LVS

Las Vegas Sands

$59.26

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SPLK

Splunk

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SON

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SHOP

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UTX

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, DE

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DE

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HD

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APEN

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HD

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, LOW

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LOW

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$NSD

NASDAQ Market Internals

$0.00

(0.00%)

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$NYE

NYSE Market Internals

$0.00

(0.00%)

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NYSE market internals summary »

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FDX

FedEx

$162.71

-2.6 (-1.57%)

10:15
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Fedex put volume heavy and directionally bearish »

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