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BMY

Bristol-Myers

$55.21

0.55 (1.01%)

, GILD

Gilead

$77.24

-0.79 (-1.01%)

19:54
10/04/16
10/04
19:54
10/04/16
19:54

FDA mandates boxed warning on some hepatitis drugs after virus reactivation

The FDA issued a warning Tuesday about the risk of hepatitis B becoming an active infection again in "any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death." The agency is requiring a boxed warning, its most prominent alert, be added to the drug labels of the medications in question that directs health professionals to screen and monitor for HBV in all patients receiving DAA treatment. It is currently unknown why the reactivation occurs, the agency said. The FDA noted that "we identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs during the 31 months from November 22, 2013 to July 18, 2016. This number includes only cases submitted to FDA, so there are likely additional cases about which we are unaware. Of the cases reported, two patients died and one required a liver transplant. HBV reactivation was not reported as an adverse event in the clinical trials submitted for the DAA approvals because patients with HBV co-infection were excluded from the trials." The FDA announcement included a list of direct-acting antivirals, which named Bristol-Myers' (BMY) Daklinza; Gilead's (GILD) Epclusa, Harvoni and Sovaldi; Johnson & Johnson's (JNJ) Olysio; AbbVie's (ABBV) Technivie and Viekira Pak; and Merck's (MRK) Zepatier. Reference Link

BMY

Bristol-Myers

$55.21

0.55 (1.01%)

GILD

Gilead

$77.24

-0.79 (-1.01%)

JNJ

Johnson & Johnson

$118.82

0.01 (0.01%)

ABBV

AbbVie

$63.00

-0.23 (-0.36%)

MRK

Merck

$62.46

-0.06 (-0.10%)

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BMY Bristol-Myers
$55.21

0.55 (1.01%)

09/27/16
PIPR
09/27/16
NO CHANGE
Target $62
PIPR
Neutral
Bristol-Myers price target lowered to $62 from $65 at Piper Jaffray
Piper Jaffray analyst Richard Purkiss lowered his price target for Bristol-Myers Squibb (BMY) to $62 saying he sees the company ceding Opdivo's early-mover advantage in lung cancer to competitors. The analyst expects to see details from Roche's (RHHBY) positive OAK trial of Tecentriq vs. docetaxel in non-small cell lung cancer at the upcoming ESMO meeting. Purkiss also expects to see details from Merck's (MRK) positive KEYNOTE-024 trial of Keytruda. The analyst lowered his post-2016 Opdivo forecasts and reiterates a Neutral rating on Bristol shares.
09/20/16
SBSH
09/20/16
NO CHANGE
Target $70
SBSH
Buy
Bristol-Myers price target lowered to $70 from $75 at Citi
In a research note titled "Brace Yourself. Attractive Valuation but No Near-Term Respite.," Citi analyst Andrew Baum lowered his price target for shares of Bristol-Myers Squibb to $70 from $75. The analyst lowered his earnings forecasts by up to 8% to reflect the "limited supportive data" in the non-small cell lung cancer indication. Baum keeps a Buy rating on the shares as he views the valuation as attractive. He points out, however, the near-term news-flow is likely to be negative.
09/12/16
JEFF
09/12/16
NO CHANGE
Target $57
JEFF
Hold
Jefferies cuts Bristol-Myers price target, upgrades AstraZeneca
Jefferies analyst Jeffrey Holford lowered his price target for Bristol-Myers Squibb (BMY) to $57 from $69 saying the stock is positioned for a "rough mid term ride." The analyst sees a "difficult catalyst" set for Bristol shares with "numerous" upcoming competitor read-outs in non-small cell lung cancer. The market could see worse than expected data from Bristol's CM-026 and CM-568 studies as well as better than expected data from AstraZeneca's (AZN) MYSTIC study and Roche's (RHHBY) Chemo-IO studies in the first half of 2017, Holford tells investors in a research note. He keeps a Hold rating on Bristol and upgraded this morning AstraZeneca to Buy from Hold. Holford prefers Astra for its immunology exposure.
09/28/16
ROTH
09/28/16
NO CHANGE
Target $23
ROTH
Buy
Nektar price target raised to $23 from $19 at Roth Capital
Roth Capital analyst Michael Higgins raised his price target for Nektar (NKTR) to $23 from $19 after the company and Bristol-Myers (BMY) announced a clinical collaboration to evaluate the combination of the latter's anti-PD-1 antibody, Opdivo, with NKTR-214. The analyst reiterates a Buy rating on Nektar's shares.
GILD Gilead
$77.24

-0.79 (-1.01%)

09/27/16
09/27/16
DOWNGRADE

On The Fly: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Gilead (GILD) downgraded to Market Perform from Outperform at Leerink with analyst Geoffrey Porges saying he's now "outright bearish" on the company's Hepatitis C virus business. 2. J.M. Smucker (SJM) downgraded to Neutral from Outperform at Credit Suisse with analyst Robert Moskow saying that while the company raised its cost savings target as expected, he underestimated the hit to sales from difficult comparisons. 3. Discovery (DISCA) and Scripps Networks (SNI) downgraded to Sell from Neutral at MoffettNathanson. 4. Carter's (CRI) downgraded to Market Perform from Outperform at Wells Fargo with analyst Ike Boruchow saying his quarter-to-date store checks indicate "choppy" retail traffic trends and "deeper" pricing/promotional pressure. 5. Dollar Tree (DLTR) downgraded to Underweight from Neutral at Atlantic Equities with analyst Sam Hudson saying the second half comp inflection expected by consensus is "too demanding" and he expects multiple contraction if Family Dollar does not turn around. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
09/27/16
LEER
09/27/16
DOWNGRADE
Target $94
LEER
Market Perform
Gilead downgraded to Market Perform from Outperform at Leerink
Leerink analyst Geoffrey Porges downgraded Gilead Sciences to Market Perform from Outperform and lowered his price target for the shares to $94 from $112. The biotech closed yesterday down 75c to $80.62. The analyst says he's now "outright bearish" on the company's Hepatitis C virus business. Gilead's HCV revenues will "decline faster, and farther," than the current consensus estimates forecast, Porges tells investors in a research note.
10/03/16
LEER
10/03/16
NO CHANGE
LEER
Market Perform
AASLD abstracts hint at potential competitive threat to Gilead HCV, says Leerink
Leerink analyst Geoffrey Porges says abstracts for the American Association for the Study of Liver Diseases, or AASLD, meeting revealed very limited efficacy information about the new Hepatitis C regimens for Gilead (GILD), Merck (MRK) and AbbVie (ABBV). Nonetheless, the analyst believes the abstracts hint at the potential competitive threat to Gilead's HCV dominance. While the new 12-week HCV regimens may compete on price, the forthcoming 8-week regimens put the most pressure on Gilead's market share, Porges argues. He reiterates a Market Perform rating on Gilead's shares.
10/03/16
RBCM
10/03/16
NO CHANGE
Target $95
RBCM
Outperform
Gilead HIV franchise could see risk from competitor data, says RBC Capital
RBC Capital analyst Michael Yee said his conversations with doctors leads him to think two dolutegravir HIV "doublet" studies being conducted by GlaxoSmithKline (GSK) and ViiV Healthcare - Glaxo's joint venture with Pfizer (PFE) and Shionogi - are likely to work and present an underappreciated risk to Gilead's (GILD) HIV franchise. Talks with investors lead Yee to believe few are even aware of this risk and that the consensus view is underestimating the probability these non-inferiority trials will work. Arguing that the consensus view should factor in more conservative assumptions for Gilead's HIV business post 2018 due to this risk, Yee cut his price target on Gilead to $95 from $105, but keeps an Outperform rating on the shares.
JNJ Johnson & Johnson
$118.82

0.01 (0.01%)

08/18/16
UBSW
08/18/16
NO CHANGE
Target $137
UBSW
Buy
Johnson & Johnson remains a top large cap pick, says UBS
UBS analyst Matt Miksic said Johnson & Johnson remains a top large cap diversified pick for the year. The analyst said yesterday's court ruling that invalidated the company's Remicade patent was expected and could delay the Q4 biosimilar launch but its robust pharma pipeline remains under-appreciated and should make up the difference. He said he continues to see further clarity regarding potential U.S. biosimilar competition for Remicade as positive for the stock. Miksic reiterated his Buy rating and $137 price target on Johnson & Johnson shares.
08/24/16
JEFF
08/24/16
NO CHANGE
Target $210
JEFF
Buy
Cooper Companies estimates raised at Jefferies after doctor survey
Jefferies analyst Anthony Petrone reports that the firm's survey of 52 new optometry practices suggest continued gains in dailies and stable share in monthlies for Cooper Companies (COO) and that Johnson & Johnson's (JNJ) Acuvue Vita is off to slow start. Based on the survey results, and a "significant" foreign exchange tailwind, Petrone raised his estimates for Cooper and increased his price target on the shares to $210 from $190. The firm has a Buy rating on Cooper shares.
09/19/16
JEFF
09/19/16
NO CHANGE
Target $48
JEFF
Buy
Abbott unit sale does not impact Alere transaction, says Jefferies
Jefferies analyst Jeffrey Holford believes Abbott's (ABT) sale of its Medical Optics business to Johnson & Johnson (JNJ) does not imply an increased probability that the Alere (ALR) deal will close. After speaking to Abbott management, Holford thinks the proceeds from the sale are more likely to be targeted towards the St. Jude Medical (STJ) acquisition. He believes that deal has a higher probability of closing than Alere. Holford has a Buy rating on Abbott with a $48 price target.
09/19/16
LEER
09/19/16
NO CHANGE
LEER
Abbott, Johnson & Johnson transaction positive for both companies, says Leerink
Leerink analyst Danielle Antalffy says the sale of Abbott's (ABT) Medical Optics ophthalmology business to Johnson & Johnson (JNJ) is positive for both companies. The deal strengthens Abbott's balance sheet and eliminates the need for a previously expected $3B capital raise, and adds a key component to Johnson & Johnson's already-strong vision care franchise, the analyst notes.
ABBV AbbVie
$63.00

-0.23 (-0.36%)

09/08/16
JPMS
09/08/16
DOWNGRADE
Target $73
JPMS
Neutral
AbbVie downgraded to Neutral from Overweight at JPMorgan
JPMorgan analyst Chris Schott downgraded AbbVie (ABBV) to Neutral citing the stock's 10% rally year-to-date and limited near-term catalysts. AbbVie's profile is now better reflected at current valuation levels, Schott tells investors in a research note. He lowered his price target for the shares to $73 from $75. The analyst coupled the downgrade with an upgrade this morning of Eli Lilly (LLY) to Overweight.
09/02/16
09/02/16
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. AbbVie (ABBV) initiated with an Outperform at Raymond James. 2. Spark Therapeutics (ONCE) initiated with a Buy at Stifel. 3. Cornerstone OnDemand (CSOD) initiated with an Overweight at Piper Jaffray. 4. UR-Energy (URG) initiated with an Outperform at FBR Capital. 5. Energy Transfer Equity (ETE) reinstated with an Overweight at JPMorgan. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
09/01/16
RAJA
09/01/16
INITIATION
Target $82
RAJA
Outperform
AbbVie initiated with an Outperform at Raymond James
Target $82.
MRK Merck
$62.46

-0.06 (-0.10%)

08/19/16
UBSW
08/19/16
NO CHANGE
Target $70
UBSW
Buy
Merck price target raised to $70 from $62 at UBS
UBS analyst Marc Goodman raised his price target on Merck (MRK) to $70 from $62 as he updated his model to account for a more favorable Keytruda opportunity following the failed CheckMate-026 trial at Bristol-Myers (BMY). The analyst also feels investors do not give enough credit to Merck's Januvia franchise or the potential for growth opportunity from the pipeline. Goodman reiterated his Buy rating on Merck shares.
09/21/16
FBCO
09/21/16
UPGRADE
Target $41
FBCO
Outperform
Clovis upgraded to Outperform from Neutral at Credit Suisse
Credit Suisse analyst Kennen MacKay upgraded Clovis Oncology (CLVS) to Outperform and raised his price target for the shares to $41 from $19. Clovis closed yesterday up 13%, or $3.92, to $34.83. The potential for a takeover "outweighs concerns surrounding patent life, limited experience in platinum resistant/refractory patients, and PARPi competition," MacKay tells investors in a research note. Clovis could be worth $35-$41 per share in a buyout on operational synergies, and $52-$55 per share with leveraged tax benefits, MacKay estimates. He points out that Eli Lilly (Lill)y, Merck (MRK), Japan's Takeda and others have expressed interest in acquiring U.S. oncology companies.

TODAY'S FREE FLY STORIES

TWTR

Twitter

$17.93

-0.1 (-0.55%)

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$108.14

-1.86 (-1.69%)

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BMRN

BioMarin

$82.21

-1.12 (-1.34%)

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0.59 (1.03%)

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ESALY

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GWPH

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3.04 (2.78%)

IART

Integra LifeSciences

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MDT

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0.16 (2.36%)

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0.35 (2.76%)

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Zynerba

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0.83 (6.48%)

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CELG

Celgene

$117.63

-1.24 (-1.04%)

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INCY

Incyte

$102.02

2.09 (2.09%)

, PFE

Pfizer

$31.63

0.17 (0.54%)

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INCY

Incyte

$102.02

2.09 (2.09%)

PFE

Pfizer

$31.63

0.17 (0.54%)

LLY

Eli Lilly

$67.71

1.74 (2.64%)

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JUNO

Juno Therapeutics

$20.43

0.53 (2.66%)

, KITE

Kite Pharma

$50.76

0.04 (0.08%)

21:25
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JUNO

Juno Therapeutics

$20.43

0.53 (2.66%)

KITE

Kite Pharma

$50.76

0.04 (0.08%)

BLUE

bluebird bio

$69.75

1.1 (1.60%)

NVS

Novartis

$68.17

0.42 (0.62%)

03/08/13
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BMRN

BioMarin

$82.21

-1.12 (-1.34%)

, ESALY

Eisai

$57.91

0.59 (1.03%)

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American Epilepsy Society to hold annual meeting »

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BMRN

BioMarin

$82.21

-1.12 (-1.34%)

ESALY

Eisai

$57.91

0.59 (1.03%)

GWPH

GW Pharmaceuticals

$112.32

3.04 (2.78%)

IART

Integra LifeSciences

$75.78

-1.07 (-1.39%)

MDT

Medtronic

$72.01

0.13 (0.18%)

MNK

Mallinckrodt

$53.61

0.51 (0.96%)

NVTA

Invitae

$6.95

0.16 (2.36%)

SAGE

SAGE Therapeutics

$49.02

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WTKWY

Wolters Kluwer

$34.08

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ZGNX

Zogenix

$13.05

0.35 (2.76%)

ZYNE

Zynerba

$13.64

0.83 (6.48%)

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Wal-Mart

$70.88

0.21 (0.30%)

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GMED

Globus Medical

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Ingram Micro

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$29.35

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JNJ

Johnson & Johnson

$111.96

0.58 (0.52%)

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Actelion

$206.01

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$111.96

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ALIOF

Actelion

$206.01

15.21 (7.97%)

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CE

Celanese

$79.10

0.3 (0.38%)

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HMST

HomeStreet

$29.35

-0.2 (-0.68%)

, GMED

Globus Medical

$21.89

0.12 (0.55%)

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$42.50

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Zendesk

$21.17

0.34 (1.63%)

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ZEN

Zendesk

$21.17

0.34 (1.63%)

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AIXG

Aixtron

$3.97

-0.05 (-1.24%)

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CX

CEMEX

$7.83

0.09 (1.16%)

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SRNE

Sorrento Therapeutics

$5.15

-0.1 (-1.90%)

17:30
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Breaking Syndicate news story on Sorrento Therapeutics »

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  • 06

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MBRX

Moleculin Biotech

$2.63

-0.14 (-5.05%)

17:29
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12/02
17:29
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Breaking Syndicate news story on Moleculin Biotech »

Moleculin Biotech files…

03/08/13
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  • 06

    Dec

NEOG

Neogen

$61.59

-1.46 (-2.32%)

17:28
12/02/16
12/02
17:28
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17:28
Hot Stocks
Neogen acquires U.K.-based Quat-Chem, terms undisclosed »

Neogen announced that it…

03/08/13
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RRC

Range Resources

$36.36

-0.23 (-0.63%)

17:25
12/02/16
12/02
17:25
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17:25
Hot Stocks
Breaking Hot Stocks news story on Range Resources »

SailingStone Capital…

03/08/13
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EOG

EOG Resources

$103.74

-1.01 (-0.96%)

17:25
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12/02
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Syndicate
Breaking Syndicate news story on EOG Resources »

EOG Resources files to…

03/08/13
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  • 13

    Dec

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