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ABBV

AbbVie

$80.64

-0.81 (-0.99%)

, RHHBY

Roche

$0.00

(0.00%)

08:48
03/19/19
03/19
08:48
03/19/19
08:48

AbbVie: FDA puts partial clinical hold on venetoclax program

AbbVie (ABBV) announced the U.S. FDA has placed a partial clinical hold on all clinical trials evaluating venetoclax for the investigational treatment of multiple myeloma. The partial clinical hold follows a review of data from the ongoing Phase 3 BELLINI trial, a study in relapsed/refractory multiple myeloma, in which a higher proportion of deaths was observed in the venetoclax arm compared to the control arm of the trial. As a result of this action, no new patients should be enrolled in any studies of venetoclax for multiple myeloma until a further analysis of the data is completed. Patients who are currently enrolled in studies and receiving benefit from the therapy may continue with treatment, after consultation with their physician. This action does not impact any of the approved indications for venetoclax, such as chronic lymphocytic leukemia or acute myeloid leukemia, and is limited to investigational clinical trials in multiple myeloma. AbbVie remains confident in the benefit/risk profile of venetoclax in those approved indications. "We are committed to patient safety and are thoroughly analyzing the results observed in the BELLINI trial. We will continue working with the FDA and worldwide regulatory agencies to determine appropriate next steps for the multiple myeloma program," said Michael Severino, M.D., vice chairman and president, AbbVie. "We will continue to further the research and development of venetoclax and other therapies with the potential to transform the standards of care in blood cancers." Venetoclax is being developed by AbbVie and Roche (RHHBY). It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

ABBV

AbbVie

$80.64

-0.81 (-0.99%)

RHHBY

Roche

$0.00

(0.00%)

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ABBV AbbVie
$80.64

-0.81 (-0.99%)

02/20/19
MSCO
02/20/19
NO CHANGE
Target $215
MSCO
Overweight
Amgen could fall over 10% if Sandoz wins Enbrel IP case, says Morgan Stanley
Morgan Stanley analyst Matthew Harrison noted that a District Court verdict is expected some time in Q1 of 2019 on the ability of Novartis' (NVS) generics division Sandoz to launch their Enbrel biosimilar, Erelzi, which received FDA approval in mid-2016 but has been blocked by a preliminary injunction obtained by Amgen (AMGN). In a scenario where the court rules in favor of Amgen, he would expect upside of 3%-5% for Amgen shares and he would expect AbbVie (ABBV) to trade up 1%-2% in sympathy. If the court rules in favor of Sandoz, Harrison would expect downside of over 10% for Amgen and would expect AbbVie shares to trade down 6%-8%. If the companies announce a settlement, he would expect 1%-2% upside for Amgen and a minimal impact on AbbVie shares, Harrison tells investors. His base case view is that the ruling is likely to be in favor of Amgen, noted Harrison, who keeps an Overweight rating on Amgen.
02/21/19
PIPR
02/21/19
NO CHANGE
Target $90
PIPR
Neutral
Piper doctor surveys show further Humira erosion outside the U.S.
Piper Jaffray analyst Christopher Raymond says new European rheumatologist and dermatologist surveys suggest further downside potential for branded Humira erosion at the hands of biosimilar competition. While AbbVie management has downwardly revised Humira outside the U.S. erosion estimates twice in recent months, we likely haven't seen the last such revision, Raymond tells investors in a research note. European doctors project that biosimilars will capture 30%-40% of adalimumab use by mid-2019, which contrasts with management's 30% fiscal 2019 erosion commentary, adds the analyst. He now models a 35% ex-U.S. fiscal 2019 Humira erosion, but fears it could be worse. Raymond continues to urge caution on shares of AbbVie, "despite a healthy 5.4% dividend yield." He keeps a Neutral rating on the stock with a $90 price target.
02/25/19
ADAM
02/25/19
NO CHANGE
Target $26
ADAM
Buy
Voyager Therapeutics deal validates CNS gene therapy platform, says Canaccord
Canaccord analyst Sumant Kulkarni noted Abbvie (ABBV) and Voyager Therapeutics (VYGR) expanded their collaboration agreement to work on Parkinson's in addition to their previous collaboration on Alzheimer's. The analyst believes the deal further validates Voyager's central nervous system gene therapy platform. Kulkarni believes Voyager shares are undervalued and he reiterated his Buy rating and $26 price target on the stock.
03/13/19
PIPR
03/13/19
NO CHANGE
Target $90
PIPR
Neutral
Piper dermatologist survey offers 'good news/bad news' for AbbVie
Piper Jaffray analyst Christopher Raymond views his firm's survey of 101 U.S. dermatologists as "good news/bad news" for AbbVie's dermatology franchise. On the positive side, due to both AbbVie's "significant goodwill" as well as risankizumab's superior clinical profile, dermatologists indicate "significant uptake" of the drug once approved, Raymond tells investors in a research note. On the negative side, Humira continues to lose market share to newer biologics like anti-IL-17s and approved anti-IL-23s at a "rapid pace" that may be accelerated by cannibalization at the hands of risankizumab, adds the analyst. Following the surgery, Raymond remains comfortable with his below-consensus AbbVie revenue estimates this year and next. He keeps a Neutral rating on the shares with a $90 price target.
RHHBY Roche
$0.00

(0.00%)

02/26/19
BERN
02/26/19
DOWNGRADE
Target $114.5
BERN
Market Perform
Spark Therapeutics downgraded to Market Perform from Outperform at Bernstein
Bernstein analyst Vincent Chen downgraded Spark Therapeutics (ONCE) to Market Perform from Outperform, with a $114.50 price target, after the company and Roche (RHHBY) announced an agreement for the latter to purchase the outstanding shares of Spark at $114.50/share. The analyst thinks "this is likely to be a done deal" as it is hard for him to see the acquisition failing to close. Overall, Chen views the risk of antitrust considerations as limited, and while there are additional players who conceivably could be interested, he suspects they have had a look and Roche was the highest bidder.
02/26/19
JEFF
02/26/19
DOWNGRADE
JEFF
Hold
Spark Therapeutics downgraded to Hold from Buy at Jefferies
Jefferies analyst Michael Yee last night downgraded Spark Therapeutics (ONCE) to Hold while raising his price target for the shares to $114.50 from $85. He believes the buyout by Roche (RHHBY) will close as expected, by Q2. Further, the analyst sees the deal as positive for other gene and cell therapy names, "as interest from large biopharma should persist as the technology matures."
02/27/19
STFL
02/27/19
DOWNGRADE
Target $114.5
STFL
Hold
Spark Therapeutics downgraded to Hold from Buy at Stifel
Stifel analyst Stephen Willey downgraded Spark Therapeutics (ONCE) to Hold from Buy and raised his price target on the stock to $114.50 from $65 to reflect the company's agreement to be acquired by Roche (RHHBY). Willey, who thinks the all-cash offer represents a highly attractive outcome for Spark shareholders and that the company represents a solid strategic fit for Roche, does not expect to see a better competitive offer emerge and expects a timely closing.
03/07/19
WBLR
03/07/19
DOWNGRADE
WBLR
Market Perform
William Blair downgrades Spark after filing points to competitive bid process
William Blair analyst Raju Prasad downgraded Spark Therapeutics (ONCE) to Market Perform from Outperform following the filing of its Schedule 14D-9 form that included a summary on the background of the merger agreement with Roche (RHHBY). The filing describes a competitive process that resulted in the final price and furthers the likelihood of the deal closing, Prasad tells investors.

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LDOS

Leidos

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-0.66 (-0.79%)

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RETA

Reata Pharmaceuticals

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Options
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AKRX

Akorn

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-0.105 (-2.69%)

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EHTH

eHealth

$53.12

-2.86 (-5.11%)

16:27
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GPN

Global Payments

$164.14

1.2 (0.74%)

16:26
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SQ

Square

$61.83

0.29 (0.47%)

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FISV

Fiserv

$106.05

0.41 (0.39%)

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FICO

Fair Isaac

$310.44

0.46 (0.15%)

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16:22
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General news
Empire State Mfg Survey General Business Conditions Index data reported »

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PD

PagerDuty

$26.45

0.27 (1.03%)

16:21
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RWT

Redwood Trust

$16.56

-0.1 (-0.60%)

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VIX

Volatility Index S&P 500 Options

$0.00

(0.00%)

16:20
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Options
Closing CBOE SPX and VIX Index summary for October 14th »

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BA

Boeing

$373.02

-1.88 (-0.50%)

, FB

Facebook

$183.29

-0.91 (-0.49%)

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On The Fly
Fly Intel: Wall Street's top stories for Monday »

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BA

Boeing

$373.02

-1.88 (-0.50%)

FB

Facebook

$183.29

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PE

Parsley Energy

$15.18

-1.8 (-10.60%)

JAG

Jagged Peak Energy

$6.72

-0.09 (-1.32%)

RVNC

Revance

$14.03

1.86 (15.28%)

HPE

HP Enterprise

$14.94

0.59 (4.11%)

SDC

SmileDirectClub

$9.71

-1.39 (-12.52%)

IPGP

IPG Photonics

$125.41

-10.71 (-7.87%)

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ACC

American Campus

$48.27

-0.32 (-0.66%)

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Earnings
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BLMN

Bloomin' Brands

$18.14

-0.84 (-4.43%)

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ASB

Associated Banc-Corp

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0.12 (0.61%)

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$NSD

NASDAQ Market Internals

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$NYE

NYSE Market Internals

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(0.00%)

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SENS

Senseonics

$0.83

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RETA

Reata Pharmaceuticals

$100.74

4.94 (5.16%)

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SANM

Sanmina

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QGEN

Qiagen

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RPAY

Repay Holdings

$13.18

-0.1 (-0.75%)

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