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SPPI

Spectrum

$10.43

-0.18 (-1.70%)

16:01
12/19/18
12/19
16:01
12/19/18
16:01

Spectrum says FDA did not grant BTD to poziotinib for treatment of NSCLC

Spectrum Pharmaceuticals, Inc. announced that based on a subset of data from MD Anderson's ongoing Phase 2 study, the U.S. Food and Drug Administration did not grant Breakthrough Therapy Designation to poziotinib for the treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 20 mutations. The company's overall development plan and timeline for a New Drug Application filing based on the first cohort of the ZENITH20 trial remains unchanged. Breakthrough Therapy Designation is one of several FDA programs designed to expedite the review of drugs to treat serious or life threatening conditions. Spectrum's BTD application included data from 30 patients from the MD Anderson Phase 2 study who had failed platinum-based chemotherapy. The data demonstrated a confirmed objective response rate of 40% and median duration of response of 6.6 months. The safety profile in this subset was consistent with historical data published on poziotinib and other tyrosine kinase inhibitors. The historical objective response rates for mutation specific NSCLC patients range between 0% and 8% with tyrosine kinase inhibitors and for non-mutation specific NSCLC patients range between 0.8% and 22.9% with other treatments.

SPPI Spectrum
$10.43

-0.18 (-1.70%)

11/12/18
RILY
11/12/18
NO CHANGE
Target $29
RILY
Buy
Spectrum price target lowered to $29 from $35 at B. Riley FBR
B. Riley FBR analyst David Buck lowered his price target for Spectrum Pharmaceuticals to $29 to reflect "some more conservatism" given the recent weakness in the group and passing of some expected catalysts. Poziotinib remains the key pipeline focus, with the company filing for breakthrough therapy confirmed with its Q3 results, Buck tells investors in a research note. He keeps a Buy rating on Spectrum.
09/06/18
JEFF
09/06/18
NO CHANGE
Target $25
JEFF
Buy
Spectrum should begin to retrace last week's selloff, says Jefferies
Jefferies analyst Matthew Andrews says the new interim poziotinib data from the MD Anderson Phase 2 non-small cell lung cancer study "don't disappoint." Shares of Spectrum Pharmaceuticals should begin to retrace the drop since last week amid concerns about the Korean poziotinib HER2 data, Andrews tells investors in a research note. The analyst believes the unconfirmed overall response rate of 58% in EGFR and 50% in HER2 are "impressive." He keeps a Buy rating on Spectrum with a $25 price target.
09/06/18
HCWC
09/06/18
NO CHANGE
Target $40
HCWC
Buy
Spectrum price target raised to $40 from $34 at H.C. Wainwright
H.C. Wainwright analyst Edward White raised his price target for Spectrum Pharmaceuticals to $40 after the company presented at his firm's conference. The analyst remains optimistic about both the stock and the company's pipeline, which he notes includes poziotinib in non-small cell lung cancer and HER2-positive breast cancer and Rolontis in chemotherapy-induced neutropenia. Progress is being made across developmental programs along with upcoming catalysts, White tells investors in a research note. He keeps a Buy rating on Spectrum.
08/31/18
RILY
08/31/18
NO CHANGE
Target $35
RILY
Buy
Spectrum price target raised to $35 from $26 at B. Riley FBR
B. Riley FBR analyst David Buck raised his price target for Spectrum Pharmaceuticals to $36 and keeps a Buy rating on the shares ahead of the company's September 5 data abstract.

TODAY'S FREE FLY STORIES

NFLX

Netflix

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2.59 (0.91%)

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MAT

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0.105 (0.92%)

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Mattel

$11.50

0.105 (0.92%)

WMT

Walmart

$119.44

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CXP

Columbia Property

$20.31

0.05 (0.25%)

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GTLS

Chart Industries

$58.79

-0.38 (-0.64%)

06:23
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AAPL

Apple

$234.59

-0.67 (-0.28%)

06:22
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GTLS

Chart Industries

$58.79

-0.38 (-0.64%)

06:21
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Earnings
Chart Industries lowers 2019 non-GAAP EPS view to $2.70-$2.90 from $2.85-$3.20 »

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WLL

Whiting Petroleum

$6.65

-0.07 (-1.04%)

06:20
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Downgrade
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LILA

Liberty Latin America

$18.14

0.14 (0.78%)

06:20
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TSLA

Tesla

$259.78

1.95 (0.76%)

06:19
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Periodicals
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CXP

Columbia Property

$20.31

0.05 (0.25%)

06:19
10/17/19
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Downgrade
Columbia Property rating change  »

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GTLS

Chart Industries

$58.79

-0.38 (-0.64%)

06:18
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Earnings
Chart Industries reports Q3 adjusted EPS 77c, consensus 77c »

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JNJ

Johnson & Johnson

$135.20

2.36 (1.78%)

, TEVA

Teva

$6.94

-0.02 (-0.29%)

06:17
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Periodicals
J&J offers to pay $4B to settle opioid litigation, WSJ reports »

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JNJ

Johnson & Johnson

$135.20

2.36 (1.78%)

TEVA

Teva

$6.94

-0.02 (-0.29%)

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  • 07

    Nov

TELNY

Telenor

$0.00

(0.00%)

06:15
10/17/19
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06:15
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06:15
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Telenor rating change  »

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  • 23

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UN

Unilever; also tag UL

$59.71

1.25 (2.14%)

, UL

Unilever; also tag UN

$59.40

1 (1.71%)

06:14
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Periodicals
Unilever cuts prices in U.S. amid shampoo rivalry with P&G, WSJ reports »

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UN

Unilever; also tag UL

$59.71

1.25 (2.14%)

UL

Unilever; also tag UN

$59.40

1 (1.71%)

PG

Procter & Gamble

$116.77

0.3 (0.26%)

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NTRA

Natera

$36.30

-2.915 (-7.43%)

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Syndicate
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NTRA

Natera

$36.30

-2.915 (-7.43%)

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Syndicate
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  • 17

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NFLX

Netflix

$286.83

2.59 (0.91%)

, DIS

Disney

$130.95

1.18 (0.91%)

06:12
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Downgrade
Macquarie downgrades Netflix to Neutral on slowing U.S. growth »

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NFLX

Netflix

$286.83

2.59 (0.91%)

DIS

Disney

$130.95

1.18 (0.91%)

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NFLX

Netflix

$286.83

2.59 (0.91%)

06:12
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Netflix analyst commentary  »

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MUX

McEwen Mining

$1.50

0.015 (1.01%)

06:12
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Hot Stocks
McEwen Mining reports Q3 production 45,930 gold equivalent ounces »

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IGLD

Internet Gold

$18.90

(0.00%)

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STI

SunTrust

$68.28

0.23 (0.34%)

06:07
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Earnings
SunTrust reports Q3 EPS $1.34, consensus $1.41 »

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ERIC

Ericsson

$8.63

0.175 (2.07%)

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Conference/Events
Ericsson to host investor update conference call »

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UNTY

Unity Bancorp

$21.12

-0.45 (-2.09%)

06:06
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Earnings
Breaking Earnings news story on Unity Bancorp »

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F

Ford

$9.06

-0.02 (-0.22%)

, AMZN

Amazon.com

$1,777.43

8.73 (0.49%)

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F

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AMZN

Amazon.com

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8.73 (0.49%)

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CREE

Cree

$47.37

-1.38 (-2.83%)

06:06
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Cree analyst commentary  »

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