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OPGN

OpGen

$1.21

-0.02 (-1.63%)

07:37
12/02/19
12/02
07:37
12/02/19
07:37

OpGen says Curetis expects near-term FDA decision on clearance of Unyvero LRT

OpGen provided a business update for the Curetis Group and announced that key milestones in the planned business combination have been achieved. Curetis recently announced that it has filed its formal response to the FDA's Additional Information Request letter regarding Curetis' filing for 510 clearance of the Unyvero LRT - Lower Respiratory Tract Application Cartridge for bronchoalveolar lavage samples. The formal response addressed all additional information requested by the FDA regarding the original submission filed on July 23, 2019. Curetis now expects a near term clearance decision. It is estimated that BAL specimens account for half of the samples obtained for the diagnosis of lower respiratory tract infections. The comprehensive LRT BAL panel covers the most clinically relevant microbial and fungal pathogens and antibiotic resistances in this indication area. The European Investment Bank, has advised Curetis GmbH that the proposed merger between Curetis and OpGen has been formally approved, subject to appropriate loan guarantees and legal documentation. On October 28, 2019, OpGen completed a $9.4M public offering. Curetis has advised OpGen that the completion of this equity financing meets the interim financing requirement specified in the September 4, 2019 Implementation Agreement between OpGen and Curetis N.V. On November 12, 2019, OpGen filed a Form S-4 with the Securities and Exchange Commission. The Form S-4 filing is currently under review by the SEC. Once finalized, the Form S-4 will serve two purposes - the proxy statement to be sent to the OpGen stockholders seeking approval of the proposed business combination, and the registration of the shares of OpGen common stock to be issued to Curetis N.V. following approval by the stockholders of OpGen and the shareholders of Curetis N.V. For the nine-month period ending September 30, 2019, Curetis Group reported total revenue of EUR1.4M, a 16% increase from the EUR1.2M reported in the prior year period. OpGen and Curetis entered into a definitive agreement to combine businesses on September 4, 2019. The closing of the transaction under such definitive agreement has not yet occurred and is subject to a number of significant closing conditions, including receipt of approval from the stockholders of OpGen, Inc. and the shareholders of Curetis, N.V. Until the closing occurs, each of OpGen and Curetis are operating as stand-alone businesses.

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BILL

Bill.com

$0.00

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FTSV

Forty Seven

$36.00

1.4 (4.05%)

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NCR

NCR Corp.

$32.60

0.16 (0.49%)

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CIEN

Ciena

$35.45

0.75 (2.16%)

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Lovesac

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CHEF

Chefs' Warehouse

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-0.06 (-0.17%)

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HSBC

HSBC

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0.44 (1.20%)

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PLCE

Children's Place

$54.36

-16.31 (-23.08%)

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Children's Place rating change at Wedbush »

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LVGO

Livongo Health

$27.55

1.48 (5.68%)

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CVX

Chevron

$116.22

-1.68 (-1.42%)

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Chevron said to be close to approving Gulf of Mexico project, Bloomberg says »

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RH

RH

$233.00

0.03 (0.01%)

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RH CEO sold 500,000 common shares of company from Dec 9 through Dec 11 »

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CRWD

Crowdstrike

$47.74

0.18 (0.38%)

19:17
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Crowdstrike CFO sells 215K shares of common stock »

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GLD

SPDR Gold Shares

$138.94

0.98 (0.71%)

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SPDR Gold Shares holdings rise to 886.22MT from 885.93MT »

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DIS

Disney

$147.70

1.58 (1.08%)

, GOOG

Alphabet

$1,345.14

0.64 (0.05%)

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GOOG

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GOOGL

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AAPL

Apple

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2.09 (0.78%)

T

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NFLX

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6.04 (2.06%)

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DLHC

DLH Holdings

$4.58

0.525 (12.96%)

, FORM

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NX

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TLRD

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NDSN

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MESA

Mesa Air

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OXM

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AKTS

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TTD

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RACE

Ferrari

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0.37 (0.22%)

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RIBT

RiceBran

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VMW

VMware

$151.00

2.27 (1.53%)

, TSLA

Tesla

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DELL

Dell Technologies

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SMTC

Semtech

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Semtech director sells 19.3K shares of common stock »

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  • 07

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CS

Credit Suisse

$12.95

-0.115 (-0.88%)

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Former Credit Suisse JV exec claims she was put under surveillance, WSJ says »

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  • 11

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PANW

Palo Alto Networks

$226.76

1.71 (0.76%)

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Palo Alto Networks CEO: No systematic problem with our sales »

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  • 08

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PBYI

Puma Biotechnology

$8.71

0.24 (2.83%)

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Puma Biotechnology presents Phase II results of neratinib in breast cancer »

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GTHX

G1 Therapeutics

$23.06

-0.18 (-0.77%)

18:05
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G1 Therapeutics presents data from Phase 1b/2a trial of lerociclib at SABCS »

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NH

NantHealth

$0.86

-0.0225 (-2.54%)

18:01
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NantHealth presents new breast cancer research findings at SABCS »

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TWTR

Twitter

$30.56

0.71 (2.38%)

, AAPL

Apple

$270.71

2.09 (0.78%)

17:51
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Twitter announces support for iOS Live Photos that will show as GIFs »

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TWTR

Twitter

$30.56

0.71 (2.38%)

AAPL

Apple

$270.71

2.09 (0.78%)

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  • 06

    Feb

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