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SYN

Synthetic Biologics

$0.76

-0.0128 (-1.66%)

07:03
11/21/18
11/21
07:03
11/21/18
07:03

Synthetic Biologics reports positive outcome of FDA meeting on SYN-004

Synthetic Biologics has completed an End-of-Phase 2 meeting with the FDA to discuss development of SYN-004 - ribaxamase - for the prevention of antibiotic-mediated Clostridium difficile infection. Pursuant to the meeting, the FDA has proposed criteria for Phase 3 clinical efficacy and safety which, if achieved, may support submission for marketing approval of ribaxamase on the basis of a single Phase 3 clinical trial. Final agreement on these criteria is contingent on FDA evaluation of a detailed Phase 3 clinical trial protocol. Synthetic Biologics, in consultation with the FDA, has confirmed the key elements of the Phase 3 clinical program to support a marketing application for ribaxamase, the company's first-in-class oral enzyme designed to degrade certain intravenous beta-lactam antibiotics within the gastrointestinal tract to prevent microbiome damage, Clostridium difficile infection, overgrowth of pathogenic organisms and the emergence of antimicrobial resistance. The FDA agreed to a primary safety endpoint of noninferiority in mortality between the ribaxamase treatment group versus placebo at 3 months post-randomization. Synthetic Biologics anticipates initiating the Phase 3 clinical program after securing additional potential financing via a strategic partnership.

  • 02

    Dec

SYN Synthetic Biologics
$0.76

-0.0128 (-1.66%)

05/09/18
GRIF
05/09/18
DOWNGRADE
GRIF
Neutral
Synthetic Biologics downgraded to Neutral from Buy at Griffin Securities
05/18/18
HCWC
05/18/18
INITIATION
Target $1
HCWC
Buy
Synthetic Biologics initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Edward White started Synthetic Biologics with a Buy rating and $1 price target. The analyst says his target is based on the outlook of the company's pipeline, which contains ribaxamase, an oral biologic to protect the gut microbiome from IV betalactam antibiotics, that could cause clostridium difficile infection.
05/18/18
05/18/18
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. MasterCard (MA) initiated with a Neutral at UBS. 2. AMD (AMD) initiated with an Outperform at Cowen while Intel (INTC) was initiated with a Market Perform. 3. Synthetic Biologics (SYN) initiated with a Buy at H.C. Wainwright. 4. Amneal Pharmaceuticals (AMRX) initiated with a Neutral at JPMorgan. 5. Apollo Commercial (ARI) initiated with a Buy at Deutsche Bank. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

TODAY'S FREE FLY STORIES

XYL

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1.5497 (2.02%)

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PBYI

Puma Biotechnology

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ADI

Analog Devices

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VHC

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AGCO

Agco

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NVDA

Nvidia

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QCOM

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INTC

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TXN

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MCHP

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MRVL

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AMD

AMD

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MU

Micron

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0.13 (0.33%)

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SYNA

Synaptics

$33.56

-9.62 (-22.28%)

15:30
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Timely put buy in Synaptics as shares shed 22.5% »

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  • 28

    May

IFSPF

Interfor

$0.00

(0.00%)

15:28
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  • 20

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QEP

QEP Resources

$7.75

0.18 (2.38%)

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Repeat risk-reversals in Qep Resources »

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AMRS

Amyris

$3.87

-0.06 (-1.53%)

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  • 18

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BX

Blackstone

$35.48

0.57 (1.63%)

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$NSD

NASDAQ Market Internals

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(0.00%)

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$NYE

NYSE Market Internals

$0.00

(0.00%)

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NYSE market internals summary »

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BX

Blackstone

$35.47

0.56 (1.60%)

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FLIR

Flir Systems

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  • 19

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STNE

StoneCo

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  • 18

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YEXT

Yext

$22.91

0.24 (1.06%)

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BKS

Barnes & Noble

$5.33

0.06 (1.14%)

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TLRY

Tilray

$70.78

-1.75 (-2.41%)

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Options
Tilray options imply 15.9% move in share price post-earnings, above median historical move »

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  • 18

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TSLA

Tesla

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  • 18

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CRAY

Cray

$24.86

-0.3 (-1.19%)

, INTC

Intel

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INTC

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  • 25

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PTE

PolarityTE

$13.56

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