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LLY

Eli Lilly

$112.35

0.57 (0.51%)

16:50
09/29/19
09/29
16:50
09/29/19
16:50

Eli Lilly announces results from Phase 3 MONARCH 2 clinical trial

Eli Lilly announced Verzenio in combination with fulvestrant significantly extended life by a median of 9.4 months in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer previously treated with endocrine therapy. Results from the Phase 3 MONARCH 2 clinical trial, which included both pre/peri- and postmenopausal women, were consistent across subgroups. Additionally, in women previously treated with endocrine therapy whose cancer quickly returned or spread to other parts of the body, called primary endocrine resistance, the results were consistent with the intent-to-treat population. Similar results were observed in women whose cancer spread to their organs, such as liver or lungs. These are characteristics of aggressive disease that indicate a woman may be more likely to do worse. Both of these analyses were pre-defined and results are consistent with the ITT results from the MONARCH 2 study which had previously demonstrated a statistically significant improvement in the primary endpoint of progression-free survival, with overall survival as a secondary endpoint of the trial. In addition to extending life, an exploratory analysis of these data has shown Verzenio in combination with fulvestrant delayed the time to chemotherapy, with a median time to chemotherapy of 50.2 months versus 22.1 months in the placebo arm. In this exploratory analysis, women who died before receiving chemotherapy were included up until the date of death. This finding may be an important treatment consideration in advanced breast cancer as physicians aim to postpone the use of chemotherapy for as long as possible. The safety profile was consistent with that of the primary analysis of MONARCH 2. No new safety signals were observed with long term follow-up and at the time of analysis, 17% of patients in the Verzenio arm remained on treatment versus 4 percent in the placebo arm. These positive results definitively showed that Verzenio plus fulvestrant reached statistical significance at a pre-planned interim analysis. Lilly will continue to monitor patients enrolled in the trial. Any additional analyses will be considered post-hoc. Lilly plans to submit these overall survival data to global regulatory authorities. Verzenio in combination with fulvestrant is currently approved in more than 50 countries worldwide. Additional data for investigational use of Verzenio presented at ESMO include results from the monarcHER trial, the first randomized clinical trial of a CDK4 & 6 inhibitor in combination with endocrine therapy versus standard-of-care chemotherapy for HR+, HER2+ patients, and results from MONARCH plus, the first trial of a CDK4 & 6 inhibitor in a predominatly Chinese population of women with HR+, HER2- advanced breast cancer.

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LLY Eli Lilly
$112.35

0.57 (0.51%)

07/17/19
RAJA
07/17/19
NO CHANGE
RAJA
Investors shouldn't overreact to drug proposal headlines, says Raymond James
Raymond James analyst Chris Meekins noted that President Donald Trump has indicated an Executive Order on drug pricing is coming soon, but he believes investors "should be cautious not to overreact" to drug related proposal headlines as he "cannot think of a single proposal that was finalized and also survived a court challenge resulting in a negative impact on earnings" yet from the Trump Administration. Given the history of the current White House to date, Meekins said he is increasingly skeptical the Administration will get anything meaningful finalized and overcome legal challenges that will impact drugmakers' earnings before the 2020 election, he tells investors in a healthcare policy note. Publicly traded large cap drugmakers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
09/05/19
09/05/19
UPGRADE
Target $107

Outperform
Incyte upgraded to Outperform from Market Perform at JMP Securities
As previously reported, JMP Securities analyst Reni Benjamin assumed coverage of Incyte (INCY) with an upgraded rating of Outperform and a $107 price target. The analyst cites the "solid fundamentals" of the company's multi-billion dollar Jakafi franchise, including its recent approval in steroid refractory acute graft-versus-host disease, which he believes remains under-appreciated by investors. Benjamin is also positive on Incyte's "marquee" partners that include Novartis (NVS) and Eli Lilly (LLY), along with its $1.7B cash position, diverse pipeline, and strong fundamentals.
09/09/19
PIPR
09/09/19
NO CHANGE
Target $85
PIPR
Neutral
Lilly's 'impressive update' raised bar higher for Blueprint, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond said he thinks Eli Lilly (LLY) issued an "impressive update" on selpercatinib at the World Lung meeting, raising the bar for Blueprint Medicines' (BPMC) pralsetinib "meaningfully higher." While selpercatinib's "best-in-class" ORR was maintained, initial durability data could be upwards of 50% better than that of pralsetinib, according to Raymond. While cautioning that his comparison is highly preliminary, Raymond said he worries that LOXO-292's superiority gap against pralsetinib "may be widening." He keeps a Neutral rating on Blueprint shares, which are down about 3% in morning trading to $75.89.
09/25/19
PIPR
09/25/19
NO CHANGE
Target $81
PIPR
Overweight
AbbVie survey supports above-consensus estimates, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on AbbVie (ABBV) shares with an $81 price target following a new rheumatologist survey by his firm's partners Spherix Global Insights. The survey indicates "robust" expectations for the company's oral JAK1 inhibitor Rinvoq, Raymond tells investors in a research note. Rheumatologists project that in six months, Rinvoq will leapfrog Eli Lilly's (LLY) Olumiant to become the second-most prescribed JAK with 5% share, says the analyst, citing the survey. He believes this supports his above-consensus Rinvoq revenue estimates.

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GLD

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TECK

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OSK

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OVLY

Oak Valley Bancorp

$16.40

-0.16 (-0.97%)

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Oak Valley Bancorp reports Q3 EPS 40c vs. 37c last year »

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FTNW

FTE Networks

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TNXP

Tonix Pharmaceuticals

$0.45

0.0048 (1.07%)

17:12
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Syndicate
Breaking Syndicate news story on Tonix Pharmaceuticals »

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RLMD

Relmada Therapeutics

$20.18

1.07 (5.60%)

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Syndicate
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Breaking General news story  »

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NWSA

News Corp.

$13.48

-0.19 (-1.39%)

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News Corp

$13.79

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Facebook reaches pact with News Corp., others for news section, WSJ says »

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NYT

New York Times

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WAIR

Wesco Aircraft

$11.01

0.01 (0.09%)

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Conference/Events
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Foamix

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BK

BNY Mellon

$45.34

0.975 (2.20%)

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FOMX

Foamix

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BAC

Bank of America

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MFGP

Micro Focus

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, OTEX

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Options
Preliminary option volume of 21.9M today »

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BA

Boeing

$344.01

-25.12 (-6.81%)

, ORCL

Oracle

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M

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