Breaking News Instant updates and real-time market news.

TSRO

Tesaro

$145.90

-1.34 (-0.91%)

05:28
01/12/17
01/12
05:28
01/12/17
05:28

TESARO receives CRL from FDA for rolapitant IV NDA

TESARO announced that the FDA has issued a Complete Response Letter, or CRL, regarding the rolapitant IV New Drug Application, or NDA, for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. FDA requested additional information regarding the in vitro method utilized to demonstrate comparability of drug product produced at the two proposed commercial manufacturers for rolapitant IV that were included in the NDA. TESARO is working expeditiously to provide the requested information. The CRL did not identify concerns related to the safety or efficacy of rolapitant IV or request additional clinical studies. No concerns were raised regarding the active pharmaceutical ingredient, which is also used for the Varub oral product. TESARO identified potential deficiencies at the original contract manufacturer for rolapitant IV drug product, secured a second drug product supplier and included data from this manufacturer in the NDA. During the NDA review, FDA requested and TESARO provided in vitro data to demonstrate comparability of drug product made at the two manufacturing sites.

  • 30

    Jun

TSRO Tesaro
$145.90

-1.34 (-0.91%)

12/27/16
FBRC
12/27/16
NO CHANGE
Target $151
FBRC
Outperform
FBR Capital ups TESARO price target to $151
FBR Capital analyst Ed White raised his price target for TESARO to $151 from $133 and keeps the Outperform rating on the shares. The oncology-focused biopharmaceutical company closed Friday up $7.27 to $139.86. TESARO recently announced that the FDA has granted Priority Review for niraparib with a June 30, 2017 action date, White tells investors in a research note. He believes niraparib could be a potential blockbuster PARP inhibitor. Meanwhile, the launch of Varubi continues to "ramp up," with sequential quarter-over-quarter unit growth of 14%, the analyst writes. White says the drug achieved a 28% share of the oral NK-1 market in the U.S. in September.
01/04/17
GABE
01/04/17
NO CHANGE
GABE
Gabelli sees Incyte as more likely target following Gilead hire
Gilead (GILD) is more likely to buy Incyte (INCY) after naming Alessandro Riva to head its Hematology and Oncology Therapeutic unit, Gabelli analyst Jing He tells investors in a research note. Dr. Riva is a Novartis (NVS) veteran while Incyte is led by a team of Novartis veterans and has collaborated with Novartis Oncology on its key drug, Jakafi, the analyst points out. He believes Incyte is "big enough to move the needle" and bring long term growth to Gilead. The analyst lists Seattle Genetics (SGEN) and TESARO (TSRO) as other potential targets for the biotech giant. He believes Incyte is the "best fit."
01/09/17
LEER
01/09/17
NO CHANGE
Target $152
LEER
Outperform
TESARO price target raised to $152 from $115 at Leerink
Leerink analyst Seamus Fernandez raised his price target for TESARO to $152 from $115 to fully incorporate his high expectations for a broad label and reflect niraparib's transformation to a commercial stage asset. The analyst notes that the "strong data" from niraparib's NOVA trial, along with the lack of an expected FDA panel, should result in a broad label in the second-line or greater ovarian cancer maintenance setting, while ongoing niraparib trials in breast cancer and front-line ovarian cancer maintenance and the company's IO platform should be additional potential drivers of upside for the stock. Fernandez sees TESARO as an "attractive takeout target," and reiterates an Outperform rating on the shares.
01/10/17
LEER
01/10/17
NO CHANGE
LEER
Outperform
ARIAD acquisition supports potential takeout premium for TESARO, says Leerink
Leerink analyst Seamus Fernandez says the acquisition of ARIAD (ARIA) by Takeda (TKPYY) for $24 per share appears to be relatively in-line with other commercial stage acquisitions, and supports a potential acquisition price for TESARO (TSRO) of greater than $170 per share based on consensus forecasts. While TESARO remains well positioned to grow independently, the analyst believes a validated PARP inhibitor like niraparib could offer a durable and strategically important product opportunity for multiple suitors. He reiterates an Outperform rating on TESARO's shares.

TODAY'S FREE FLY STORIES

TWTR

Twitter

$20.13

-0.4 (-1.95%)

14:50
07/21/17
07/21
14:50
07/21/17
14:50
Options
Defensive option play in Twitter ahead of earnings next week »

Defensive option play in…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 21

    Jul

  • 13

    Sep

GS

Goldman Sachs

$220.60

-1.7 (-0.76%)

14:47
07/21/17
07/21
14:47
07/21/17
14:47
Conference/Events
Goldman Sachs to hold a conference call »

EVP & CFO Chavez and…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 01

    Aug

  • 17

    Oct

RL

Ralph Lauren

$74.91

1.15 (1.56%)

14:45
07/21/17
07/21
14:45
07/21/17
14:45
Options
Ralph Lauren call volume above normal and directionally bullish »

Bullish option flow…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 27

    Jul

  • 10

    Aug

WHLR

Wheeler REIT

$11.01

0.28 (2.61%)

14:41
07/21/17
07/21
14:41
07/21/17
14:41
Hot Stocks
NS Advisors reports 5.4% stake in Wheeler REIT »

Recently, NS Advisors has…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 09

    Aug

BKJ

Bancorp of New Jersey

$16.80

-0.2 (-1.18%)

14:30
07/21/17
07/21
14:30
07/21/17
14:30
Hot Stocks
Breaking Hot Stocks news story on Bancorp of New Jersey »

Clover Partners reports…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

AMPH

Amphastar

$17.92

0.18 (1.01%)

, MNTA

Momenta

$17.25

0.35 (2.07%)

14:29
07/21/17
07/21
14:29
07/21/17
14:29
Recommendations
Amphastar, Momenta, Novartis analyst commentary  »

Amphastar…

AMPH

Amphastar

$17.92

0.18 (1.01%)

MNTA

Momenta

$17.25

0.35 (2.07%)

NVS

Novartis

$84.78

-0.64 (-0.75%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 02

    Aug

  • 17

    May

MNTA

Momenta

$17.25

0.35 (2.07%)

14:22
07/21/17
07/21
14:22
07/21/17
14:22
Hot Stocks
Momenta: Jury finds patent on Lovenox manufacturing infringed but invalid »

Momenta Pharmaceuticals…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 02

    Aug

WLL

Whiting Petroleum

$5.02

-0.0951 (-1.86%)

14:20
07/21/17
07/21
14:20
07/21/17
14:20
Options
Second day of interest in Whiting Petroleum Jan 8 calls »

Second day of interest in…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 27

    Jul

$NSD

NASDAQ Market Internals

14:17
07/21/17
07/21
14:17
07/21/17
14:17
Technical Analysis
NASDAQ market internals summary »

Volume is average for…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

$NYE

NYSE Market Internals

14:16
07/21/17
07/21
14:16
07/21/17
14:16
Technical Analysis
NYSE market internals summary »

Volume is below average…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

FAST

Fastenal

$43.07

0.39 (0.91%)

14:15
07/21/17
07/21
14:15
07/21/17
14:15
Options
Fastenal put volume heavy and directionally bearish »

Bearish flow noted in…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

14:15
07/21/17
07/21
14:15
07/21/17
14:15
General news
Treasury Action: supply complicates trading in the coming week »

Treasury Action: supply…

14:10
07/21/17
07/21
14:10
07/21/17
14:10
General news
NY Fed's overnight reverse repo totaled $122.7 B, with 37 counterparties »

NY Fed's overnight…

IWM

iShares Trust Russell 2000 Index Fund

$142.55

-0.65 (-0.45%)

, RUT

Russell 2000 Index

14:08
07/21/17
07/21
14:08
07/21/17
14:08
Technical Analysis
On The Fly: Weekly technical notes for Russell 2000 »

The Russell 2000 (RUT)…

IWM

iShares Trust Russell 2000 Index Fund

$142.55

-0.65 (-0.45%)

RUT

Russell 2000 Index

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

SPY

SPDR S&P 500 ETF Trust

$246.68

-0.42 (-0.17%)

, SPX

S&P 500

14:07
07/21/17
07/21
14:07
07/21/17
14:07
Technical Analysis
On The Fly: Weekly technical notes for S&P 500 »

The S&P 500 (SPX)…

SPY

SPDR S&P 500 ETF Trust

$246.68

-0.42 (-0.17%)

SPX

S&P 500

AAPL

Apple

$150.34

-0.68 (-0.45%)

IBM

IBM

$146.68

-0.98 (-0.66%)

XLK

Technology Select Sector SPDR

$57.38

-0.16 (-0.28%)

XLU

Utilities SPDR

$52.98

0.065 (0.12%)

XLV

Health Care Select Sector SPDR

$81.00

-0.08 (-0.10%)

XLP

Consumer Staples Sector SPDR

$54.98

-0.01 (-0.02%)

XLE

Energy Select Sector SPDR

$65.26

-0.5 (-0.76%)

XLF

Financial Select Sector

$24.85

0.05 (0.20%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 01

    Aug

14:05
07/21/17
07/21
14:05
07/21/17
14:05
General news
FX Action: USD-JPY »

FX Action: USD-JPY posted…

ECA

Encana

$9.95

0.28 (2.90%)

14:00
07/21/17
07/21
14:00
07/21/17
14:00
Options
Encana with a large call ratio spread as a bullish play is adjusted »

Encana with a large call…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 21

    Jul

TJX

TJX

$68.63

-0.97 (-1.39%)

13:55
07/21/17
07/21
13:55
07/21/17
13:55
Options
TJX put volume heavy and directionally bearish »

Bearish flow noted in TJX…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

S

Sprint

$8.50

0.12 (1.43%)

, SFTBF

SoftBank

$83.15

-0.02 (-0.02%)

13:53
07/21/17
07/21
13:53
07/21/17
13:53
Periodicals
Sprint enters into partnership talks with Comcast, Charter, Nikkei reports »

SoftBank (SFTBF)…

S

Sprint

$8.50

0.12 (1.43%)

SFTBF

SoftBank

$83.15

-0.02 (-0.02%)

CMCSA

Comcast

$39.49

0.15 (0.38%)

CMCSK

Comcast

TMUS

T-Mobile

$61.12

-0.85 (-1.37%)

CHTR

Charter

$345.30

-1.31 (-0.38%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 27

    Jul

  • 27

    Jul

  • 01

    Aug

  • 03

    Aug

  • 08

    Aug

  • 14

    Aug

BTG

B2Gold

$2.75

0.04 (1.48%)

13:40
07/21/17
07/21
13:40
07/21/17
13:40
Options
In the money call write in B2Gold »

In the money call write…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

MPB

Mid Penn Bancorp

$26.30

-0.2 (-0.75%)

13:37
07/21/17
07/21
13:37
07/21/17
13:37
Hot Stocks
Mid Penn Bancorp receives regulatory clearance to open Halifax branch »

Mid Penn Bank, subsidiary…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

NRG

NRG Energy

$24.20

0.089 (0.37%)

13:30
07/21/17
07/21
13:30
07/21/17
13:30
Options
Notable new position opened in NRG options »

Notable new position…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 03

    Aug

13:30
07/21/17
07/21
13:30
07/21/17
13:30
General news
Action Economics Survey results: »

Action Economics Survey…

HAIN

Hain Celestial

$42.79

1.05 (2.52%)

13:23
07/21/17
07/21
13:23
07/21/17
13:23
Conference/Events
Hain Celestial management to meet with Jefferies »

Meetings to be held in…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 24

    Jul

VIX

Volatility Index S&P 500 Options

13:20
07/21/17
07/21
13:20
07/21/17
13:20
Options
Impressive 3-way boosts VIX option volume by a million contracts »

Impressive 3-way boosts…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

Get Full Fly Access

Breaking market intelligence sent straight to you
Our team of experts analyze every news story and filter out the noise to deliver real-time market moving news.
Up-to-date information on important industry events
Get real-time updates on events that are moving the market—from conferences and calls to syndicate announcements.
News focused on the companies in your portfolio
Create up to 12 portfolios with 150 stocks each, and see how active they are in market news.