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ABBV

AbbVie

$88.28

0.06 (0.07%)

, NBIX

Neurocrine

$86.00

-13.65 (-13.70%)

17:37
11/14/18
11/14
17:37
11/14/18
17:37

AbbVie reports 'positive' data from Phase 3 elagolix studies

AbbVie (ABBV), in cooperation with Neurocrine Biosciences (NBIX), presented for the first time additional results from two replicate pivotal Phase 3 clinical trials evaluating the efficacy and safety of elagolix in women with uterine fibroids. These results were presented at the 47th American Association of Gynecologic Laparoscopists Global Congress on Minimally Invasive Gynecology in Las Vegas, NV. At the final month of the six-month treatment period, results demonstrated that elagolix, in combination with low-dose hormone therapy, reduced heavy menstrual bleeding associated with uterine fibroids compared to placebo. In ELARIS UF-1, 68.5 percent of women with uterine fibroids achieved clinical response compared to placebo. In ELARIS UF-2, 76.2 percent of women with uterine fibroids achieved clinical response compared to placebo. In both studies, clinical response was defined as menstrual blood loss volume of less than 80 mL during final month and a 50 percent or greater reduction in menstrual blood loss volume from baseline to final month. Other efficacy endpoint results included nearly half of women in ELARIS UF-1 and 52.9 percent of women in ELARIS UF-2 achieved amenorrhea at the final month of the six-month treatment period with elagolix, in combination with add-back therapy, as measured by the alkaline hematin method. For both studies, results showed improvements in patient-reported symptom severity and quality of life related to uterine fibroids based on the disease-specific Uterine Fibroids Symptom and Health-Related Qualify of Life questionnaire. The overall safety profile for elagolix at the end of the treatment period was consistent with what was observed in Phase 2 studies in uterine fibroids and no new safety signals were identified. Hypoestrogenic effects consistent with the mechanism of action, such as hot flush and reduction in bone mineral density, from elagolix treatment were observed in the studies. These effects were observed less frequently among women who received elagolix in combination with add-back therapy compared to elagolix alone. The most frequent adverse events reported during the treatment period for elagolix, in combination with add-back therapy, were hot flush, nausea, headache, night sweats and fatigue. Data from the Phase 3 clinical trial program will support regulatory submission for elagolix in uterine fibroids, anticipated in mid-2019. Elagolix in uterine fibroids is investigational and has not been proven safe and effective.

ABBV

AbbVie

$88.28

0.06 (0.07%)

NBIX

Neurocrine

$86.00

-13.65 (-13.70%)

  • 14

    Nov

ABBV AbbVie
$88.28

0.06 (0.07%)

11/06/18
ARGS
11/06/18
NO CHANGE
Target $115
ARGS
Buy
AbbVie price target lowered to $115 from $130 at Argus
Argus analyst David Toung lowered his price target on AbbVie to $115 to reflect the competitive environment for its Humira sales from biosimilars in Europe, but also kept his Buy rating and raised his FY18 EPS view by 9c to $7.91 and FY19 by 12c to $9.00. The analyst says Humira should continue to post "solid growth" in the U.S. markets, and also cites the prospects of its Imbruvica, Venclexta Orilissa and hepatitis C drugs along with its remaining product pipeline. Toung contends that the "incremental sales of new faster-growing products can more than offset the expected decline in overseas sales of Humira".
11/02/18
PIPR
11/02/18
NO CHANGE
PIPR
AbbVie Q3 results do not convince Piper Jaffray to get off sidelines
Piper Jaffray analyst Christopher Raymond maintained a Neutral rating on AbbVie after the company's Q3 earnings results, which Raymond noted were better than expected. However, the analyst was cautious given management's indication of growing headwinds, which he believes "portend a meaningful downward revision to FY19 consensus." Additionally, Raymond sees AbbVie "married to the prospects of Humira," which he believes now faces international headwinds competing with four biosimilars.
10/30/18
NOMU
10/30/18
NO CHANGE
Target $140
NOMU
Buy
Galapagos price target raised to $140 from $124 at Nomura Instinet
Nomura Instinet analyst Christopher Marai raised his price target for Galapagos NV to $140 following last week's Q3 results and the sale of its partnered-cystic fibrosis program back to AbbVie (ABBV) for $45M upfront and $200M in milestones. The analyst views the upfront payments as upside to expectations and keeps a Buy rating on Galapagos shares.
10/25/18
BMOC
10/25/18
NO CHANGE
Target $192
BMOC
Outperform
Vertex price target lowered to $192 from $204 at BMO Capital
BMO Capital analyst Do Kim lowered his price target on Vertex (VRTX) to $192, saying its in-line Q3 results may be overshadowed by the AbbVie (ABBV) decision to license rights to Galapagos (GLPG) cystic fibrosis program, since the expectation was for the collaboration to dissolve. The analyst adds that while the Galapagos interim data did not make competitive inroads on Vertex therapies, he is still lowering the the FY19 EPS view for the latter to $4.43 from $5.13 on slow ex-U.S. growth amid reimbursement challenges and higher operating expenses. Longer term, Kim keeps his Outperform rating on Vertex.
NBIX Neurocrine
$86.00

-13.65 (-13.70%)

11/13/18
LEER
11/13/18
INITIATION
Target $110
LEER
Market Perform
Neurocrine initiated with a Market Perform at Leerink
Leerink analyst Marc Goodman started Neurocrine with a Market Perform and $110 price target as he initiates Neuroscience space with a Positive View. The analyst believes the Neuroscience sector is experiencing a "renaissance" as multiple new agents and mechanisms are coming up the pipeline across major therapeutic areas, the number of clinical studies is growing nicely, and the FDA is friendly to innovation in this space, companies are getting smarter about speed-to-market strategies and selecting niche sub-populations to focus on for initial product approvals, payer pushback on usage is much lower than in other categories, and physicians are enthusiastic about new agents. Regarding Neurocrine, Goodman believes Ingrezza should be a significant product for TD/TS but consensus sales expectations are already high.
11/12/18
LEER
11/12/18
INITIATION
Target $110
LEER
Market Perform
Neurocrine initiated with a Market Perform at Leerink
Leerink Partners analyst Marc Goodman started Neurocrine Biosciences with a Market Perform rating and $110 price target.
10/05/18
PIPR
10/05/18
NO CHANGE
Target $115
PIPR
Overweight
Piper positive on Neurocrine potential in Tourette's after doctor survey
After conducting a survey of 25 psychiatrists who manage pediatric patients with Tourette syndrome, Piper Jaffray analyst David Amsellem has heightened confidence that Neurocrine Biosciences' Ingrezza will have a significant role in the treatment landscape. To the extent that there is a label expansion in Tourette's, the product is likely to be seen as a more attractive dopaminergic-based agent relative to atypical antipsychotics, Amsellem tells investors in a research note. The analyst continues to believe that the upside potential for Neurocrine shares associated with favorable results in Tourette's is "significantly larger than the downside risk associated with a clinical setback." He reiterates an Overweight rating on the shares with a $115 price target.
09/20/18
STFL
09/20/18
NO CHANGE
Target $142
STFL
Buy
Neurocrine odds of success in Tourette's raised to 75% at Stifel
Stifel analyst Paul Matteis said his additional research on approved Tourette's Syndrome therapies, treatment guidelines, and the details of the T-FORCE GOLD study make him bullish that Neurocrine's valbenazine should succeed in its "very well powered" Phase 3 trial. The analyst, who believes the stock currently prices in a 40%-50% probability of success, raised his own take on the odds of success for the valbenazine program to 75% from 60%. He keeps a Buy rating on Neurocrine shares and increased his price target on the stock to $142 from $137.

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DB

Deutsche Bank

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MXIM

Maxim Integrated

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GLD

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Golden Minerals

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DMPI

DelMar Pharmaceuticals

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17:25
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Amerco

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Intellia Therapeutics

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Novelion Therapeutics

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LMT

Lockheed Martin

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OncoSec

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Tonix Pharmaceuticals

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Civeo

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Assured Guaranty

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Ra Medical Systems

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Pembina Pipeline

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APEN

Apollo Endosurgery

$3.50

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LQDA

Liquidia Technologies

$5.23

-0.38 (-6.77%)

16:35
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Visa

$175.24

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Visa CFO Prabhu sells over 25,000 class A common shares »

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