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MBRX

Moleculin Biotech

$2.54

-0.12 (-4.51%)

07:39
08/09/17
08/09
07:39
08/09/17
07:39

Moleculin Biotech comments on recent FDA drug approval for AML

Moleculin Biotech commented on several recent FDA approvals for new drugs for the treatment of acute myeloid leukemia, or AML. Walter Klemp, CEO of Moleculin commented: "the recent approvals of three new drugs for the treatment of AML are exciting, since they provide additional options for treatments in defined subpopulations, and because they help underscore the magnitude of the potential opportunity for Annamycin, which we will be studying for relapsed or refractory AML. With regard to AML, Rydapt is approved only for patients with a specific gene mutation, and for use in combination with the standard of care chemotherapy. Vyxeos is approved as an option to the standard of care, but only for specific AML patients, namely those with newly-diagnosed therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes. Jazz Pharmaceuticals purchased this drug in their $1.5 billion acquisition of Celator Pharmaceuticals." Klemp continued: "although FDA approval of both of those drugs was based on overall survival comparisons with a standard of care, Idhifa was approved based on an accelerated clinical trial design that showed a 19% response rate in patients with relapsed or refractory AML and IDH2 mutation. What's interesting is that Idhifa was approved with a single Phase 1/2 clinical trial based on response rate, not overall survival, and a relatively low response rate at that. Also, the patient population for which it is approved represents only 13% of all AML patients. We look forward to working with FDA on a similar approach for Annamycin -- reliance on response rate in an accelerated path -- but for a larger population of AML patients. While these new drugs make valuable incremental improvements in AML therapy," concluded Klemp, "most AML patients will still fail to respond to initial therapy; therefore, our initial clinical development plan will attempt to address the significant unmet need of patients who relapse from, or are refractory to, initial therapy. We also believe that, if Annamycin can demonstrate superior efficacy and safety to the current standard of care, the drug may be able to fill major areas for first-line AML treatment. In the meantime, these transactions serve to remind us of the opportunity for our company if Annamycin shows significant activity in our planned clinical trials."

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BXP

Boston Properties

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LFC

China Life Insurance

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0.04 (0.26%)

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Hershey

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RVLT

Revolution Lighting

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-0.03 (-0.44%)

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Amicus

$12.60

0.31 (2.52%)

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Ironwood

$14.92

0.06 (0.40%)

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Ironwood

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OTIC

Otonomy

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-0.1 (-0.51%)

SRPT

Sarepta

$37.43

0.72 (1.96%)

RXDX

Ignyta

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CSVI

Computer Services

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0.45 (0.98%)

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Computer Services announces retirement of president R. Stanley Eckenberg »

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ROIC

Retail Opportunity

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0.09 (0.45%)

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BABA

Alibaba

$159.50

1.75 (1.11%)

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AAPL

Apple

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-0.68 (-0.42%)

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Periodicals
Apple Watch may not support voice calls at launch, AI reports »

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WMT

Wal-Mart

$80.98

0.21 (0.26%)

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Breaking Hot Stocks news story on Wal-Mart »

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TDOC

Teladoc

$30.05

-1.15 (-3.69%)

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AERI

Aerie Pharmaceuticals

$52.20

-0.2 (-0.38%)

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Aerie Pharmaceuticals analyst commentary  »

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BABA

Alibaba

$159.50

1.75 (1.11%)

, MU

Micron

$30.69

1.01 (3.40%)

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Unusual call flow in option market yesterday »

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BABA

Alibaba

$159.50

1.75 (1.11%)

MU

Micron

$30.69

1.01 (3.40%)

FCX

Freeport McMoRan

$14.77

0.8 (5.73%)

VALE

Vale

$10.10

0.32 (3.27%)

RIG

Transocean

$7.58

-0.33 (-4.17%)

MPC

Marathon Petroleum

$51.06

-0.83 (-1.60%)

COTY

Coty

$19.67

0.11 (0.56%)

PAGP

Plains GP Holdings

$20.35

-0.46 (-2.21%)

ETSY

Etsy

$15.60

-0.04 (-0.26%)

FOLD

Amicus

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0.31 (2.52%)

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REG

Regency Centers

$65.52

0.46 (0.71%)

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COMM

CommScope

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0.01 (0.03%)

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MSG

Madison Square Garden

$217.42

1.33 (0.62%)

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MSG reports Q4 EPS ($3.58), may not compare to consensus ($1.39) »

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ARAY

Accuray

$4.00

-0.1 (-2.44%)

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Accuray's Radixact system used by Summit Cancer Center-Boise for the first time »

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  • 22

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AMOV

America Movil, also tag AMX

$18.51

-0.07 (-0.38%)

, AMX

America Movil, also tag AMOV

$18.82

0.22 (1.18%)

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Mexican Supreme Court rules for America Movil on interconnection fees, WSJ says »

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America Movil, also tag AMX

$18.51

-0.07 (-0.38%)

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America Movil, also tag AMOV

$18.82

0.22 (1.18%)

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GDEN

Golden Entertainment

$21.41

0.23 (1.09%)

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Golden Entertainment completes syndication of financing to fund American deal »

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PBR

Petrobras

$8.65

0.06 (0.70%)

, CBI

CB&I

$9.97

-1.22 (-10.90%)

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Unusual put flow in option market yesterday »

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PBR

Petrobras

$8.65

0.06 (0.70%)

CBI

CB&I

$9.97

-1.22 (-10.90%)

URBN

Urban Outfitters

$19.76

2.94 (17.48%)

CL

Colgate-Palmolive

$71.93

0.13 (0.18%)

AXON

Axovant Sciences

$21.80

-0.83 (-3.67%)

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  • 18

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CSCO

Cisco

$32.34

0.25 (0.78%)

07:28
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07:28
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  • 06

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LB

L Brands

$38.95

0.5 (1.30%)

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CSCO

Cisco

$32.34

0.25 (0.78%)

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  • 06

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CCL

Carnival

$68.87

0.16 (0.23%)

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QTNA

Quantenna Communications

$17.79

-0.23 (-1.28%)

07:27
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Quantenna Communications management to meet with Deutsche Bank »

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