Breaking News Instant updates and real-time market news.

MRK

Merck

$79.40

-0.44 (-0.55%)

12:46
04/14/19
04/14
12:46
04/14/19
12:46

Merck presents results from Phase 3 trial evaluating ZERBAXA

Merck announced the first presentation of results from ASPECT-NP, a randomized, double-blind, multi-center Phase 3 clinical trial evaluating the efficacy and safety of ZERBAXA for the treatment of adult patients with ventilated nosocomial pneumonia. The results demonstrated non-inferiority of an investigational dose of ZERBAXA to meropenem, the active comparator, in the primary and key secondary endpoints. Based on these results, Merck has submitted supplemental new drug applications to the U.S. Food and Drug Administration and European Medicines Agency seeking regulatory approval for ZERBAXA for this potential new indication. The FDA Prescription Drug User Fee Act date is June 3, 2019. ASPECT-NP is a prospective, randomized, double-blind, multicenter, non-inferiority, Phase 3 clinical trial to evaluate the safety and efficacy of ZERBAXA compared to meropenem in ventilated patients diagnosed with nosocomial pneumonia, including hospital-acquired and ventilator-associated bacterial pneumonia. In the study, 726 patients were randomized 1:1 to receive an investigational 3g dose of ZERBAXA or meropenem 1g dose, administered intravenously every eight hours for eight to 14 days. Meropenem is an approved broad-spectrum injectable antibiotic widely used to treat serious infections. The primary and key secondary endpoints are Day 28 all-cause mortality and Clinical Response at test-of-cure in the intent-to-treat population. ZERBAXA was non-inferior to meropenem for the primary endpoint of 28-day all-cause mortality in the ITT population, 24.0% and 25.3% respectively, for a weighted proportion difference of 1.1%. In addition, ZERBAXA was non-inferior to meropenem in the key secondary endpoint, clinical cure at Test-of-Cure in the ITT population, 54.4% and 53.3% respectively, for a weighted proportion difference of 1.1%. Additionally, an analysis of efficacy outcomes by causative pathogens showed that clinical and microbiologic response rates for ZERBAXA were comparable to meropenem for Gram-negative respiratory tract pathogens, including Pseudomonas aeruginosa and Enterobacteriaceae. In the microbiologically evaluable population in patients with a Gram-negative pathogen at baseline clinical cure rates were 75.2% and 66.7% and microbiologic response rates were 69.9% and 62.4% for ZERBAXA and meropenem respectively. Results were consistent in the microbiologic intention-to-treat population with clinical cure rates of 73% and 67.9% for ZERBAXA and meropenem respectively. Treatment-emergent adverse events were reported in 85.9% of ZERBAXA versus 83.3% of meropenem treated patients. The incidence of treatment-related AEs was 10.5% in the ZERBAXA group and 7.5% in the meropenem group. The most commonly reported AEs with ZERBAXA were abnormal liver function tests, Clostridium difficile colitis and diarrhea. Comparable rates of AEs were reported for ZERBAXA and meropenem in critically ill patients, and approximately 1% of patients had treatment-related AEs leading to discontinuation of therapy.

  • 17

    Apr

  • 30

    Apr

  • 18

    May

  • 03

    Jun

  • 17

    Jun

  • 20

    Jun

  • 16

    Jul

  • 06

    Aug

  • 20

    Sep

MRK Merck
$79.40

-0.44 (-0.55%)

02/22/19
CANT
02/22/19
INITIATION
Target $95
CANT
Overweight
Merck initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Louise Chen started Merck with an Overweight rating and $95 price target. The company's sales growth across oncology, vaccines, animal health, and select hospital/specialty care products, as well as its margin expansion opportunities, are underappreciated at current share levels, Chen tells investors in a research note. She expects upward earnings revisions and multiple expansion in 2019 to drive Merck shares higher.
03/11/19
WBLR
03/11/19
NO CHANGE
WBLR
Outperform
William Blair sum-of-the-parts analysis yields $19.80 value for Pfenex
The majority of Pfenex (PFNX) investor focus has been placed on lead asset PF708, the therapeutic equivalent product candidate to Forteo, William Blair analyst Andy Hsieh tells investors in a research note, citing his talks with clients. The analyst, however, sees "potential for significant value" from the company's collaboration with Jazz Pharmaceuticals (JAZZ). The deal with Jazz could provide patients with an alternative to Erwinaze/Erwinase, which currently suffers from significant supply constraints, and CRM197, a carrier protein that is incorporated as an adjuvant in several vaccine candidates, including Merck's (MRK) pneumococcal vaccine, V114, Hsieh writes. Based on these royalties, the analyst conducted a sum-of-the-parts analysis for Pfenex based on discounted cash flow, and the resulting net present value yielded a value of $19.80 per share. The stock closed Monday at $4.26. The analyst believes the company's "value-creating" catalysts this year, including milestone payment from Jazz for the successful tech transfer of PF743 and PF745 and the approval of PF708, coupled with his valuation analysis, affirm his bullish thesis. Hsieh believes Pfenex shares offer one of the best risk/reward symmetries in small-cap biotech and reiterates an Outperform rating on the name.
03/13/19
CANT
03/13/19
NO CHANGE
Target $95
CANT
Overweight
Merck opportunity in China is underappreciated, says Cantor Fitzgerald
After taking a deeper look at the Chinese PD-1 market, Cantor Fitzgerald analyst Louise Chen believes it could equate to billions of sales that are not yet in the forecasts for Merck's Keytruda. She thinks the peak sales potential of PD-1s in China remains underappreciated. China's pharma market can grow to $225B by 2025, which would support a growing PD-1/PD-L1 market, Chen tells investors in a research note titled "Deep Dive into China: A Complicated but Underappreciated Opportunity." The analyst keeps an Overweight rating on Merck with a $95 price target.
03/20/19
SBSH
03/20/19
NO CHANGE
SBSH
Bayer shares likely to remain 'depressed' pending trial success, says Citi
While sentiment will "clearly take a knock" at the second Roundup trial going against Bayer (BAYRY), both verdicts were delivered by juries in California and EUR 22B of litigation risk is already priced into the shares, Citi analyst Peter Verdult tells investors in a research note. The analyst says his legal checks continue to instruct him to be more focused on the upcoming Hall vs. Monsanto trial being held in St Louis from April 1. He says that verdict will better determine whether his estimate of a potential settlement liability of $1B-$6B needs to be refined. However, Bayer shares will "likely remain depressed" until there is evidence of the company prevailing in one or more of the six cases to go to trial in 2019, Verdult contends. He keeps a Buy rating on the stock but prefers other Pharma plays AstraZeneca (AZN), Sanofi (SNY), Novartis (NVS) and Merck (MRK).

TODAY'S FREE FLY STORIES

01:50
09/17/19
09/17
01:50
09/17/19
01:50
General news
FX Update: The Australian dollar ebbed to an 11-day low »

FX Update: The Australian…

01:35
09/17/19
09/17
01:35
09/17/19
01:35
General news
FX Action: »

FX Action: The Dollar…

01:25
09/17/19
09/17
01:25
09/17/19
01:25
General news
FOMC outlook: »

FOMC outlook: the Fed…

01:25
09/17/19
09/17
01:25
09/17/19
01:25
General news
Asian Market Wrap: »

Asian Market Wrap:…

XLRN

Acceleron

$44.67

0.75 (1.71%)

22:05
09/16/19
09/16
22:05
09/16/19
22:05
Recommendations
Acceleron analyst commentary at Piper Jaffray »

Acceleron's ACE-083…

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

  • 17

    Oct

  • 17

    Oct

  • 04

    Dec

  • 04

    Apr

PNRL

Paringa Resources

$2.28

-0.06 (-2.56%)

20:18
09/16/19
09/16
20:18
09/16/19
20:18
Hot Stocks
Paringa Resources names Jim Middleton as Executive Advisor »

Paringa Resources is…

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

RBNC

Reliant Bancorp

$24.70

0.16 (0.65%)

20:17
09/16/19
09/16
20:17
09/16/19
20:17
Hot Stocks
Reliant Bancorp to buy Tennessee Community Bank Holdings for $37.2M »

Reliant Bancorp announced…

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

  • 23

    Sep

ORCL

Oracle

$53.12

-0.64 (-1.19%)

, INTC

Intel

$52.21

-0.32 (-0.61%)

19:12
09/16/19
09/16
19:12
09/16/19
19:12
Hot Stocks
Intel, Oracle collaborate on Optane DC Persistent Memory »

Intel (INTC) and Oracle…

ORCL

Oracle

$53.12

-0.64 (-1.19%)

INTC

Intel

$52.21

-0.32 (-0.61%)

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

    Oct

ORCL

Oracle

$53.12

-0.64 (-1.19%)

, VMW

VMware

$155.87

4.81 (3.18%)

19:08
09/16/19
09/16
19:08
09/16/19
19:08
Hot Stocks
VMware, Oracle expand partnership on hybrid cloud »

Oracle (ORCL) and VMware…

ORCL

Oracle

$53.12

-0.64 (-1.19%)

VMW

VMware

$155.87

4.81 (3.18%)

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

  • 10

    Oct

ACRS

Aclaris Therapeutics

$1.09

0.06 (5.83%)

, BBCP

Concrete Pumping

$4.40

0.265 (6.41%)

19:05
09/16/19
09/16
19:05
09/16/19
19:05
Hot Stocks
Fly Intel: After Hours Movers »

HIGHER: Aclaris…

ACRS

Aclaris Therapeutics

$1.09

0.06 (5.83%)

BBCP

Concrete Pumping

$4.40

0.265 (6.41%)

GLW

Corning

$30.04

-0.12 (-0.40%)

XLRN

Acceleron

$44.67

0.75 (1.71%)

SHOP

Shopify

$337.93

-0.77 (-0.23%)

KHC

Kraft Heinz

$29.62

0.37 (1.27%)

PSTV

Plus Therapeutics

$9.51

-0.05 (-0.52%)

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

  • 16

    Sep

  • 18

    Sep

  • 01

    Oct

  • 17

    Oct

  • 17

    Oct

  • 04

    Dec

  • 04

    Apr

  • 17

    Sep

KHC

Kraft Heinz

$29.62

0.37 (1.27%)

19:03
09/16/19
09/16
19:03
09/16/19
19:03
Hot Stocks
3G Capital sells 25.1M shares of Kraft Heinz »

In a regulatory filing,…

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

    Oct

KHC

Kraft Heinz

$29.62

0.37 (1.27%)

18:53
09/16/19
09/16
18:53
09/16/19
18:53
Hot Stocks
Kraft Heinz's Lemann acquires nearly 3.5M common shares »

In a regulatory filing,…

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

    Oct

HMSY

HMS Holdings

$37.14

0.24 (0.65%)

18:43
09/16/19
09/16
18:43
09/16/19
18:43
Hot Stocks
HMS Holdings acquires VitreosHealth for approximately $36.5M »

HMS Holdings announced it…

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

18:25
09/16/19
09/16
18:25
09/16/19
18:25
General news
U.S. industrial production preview: »

U.S. industrial…

18:25
09/16/19
09/16
18:25
09/16/19
18:25
General news
Treasury Market Summary »

Treasury Market Summary:…

ICAD

iCAD

$6.89

-0.01 (-0.14%)

18:25
09/16/19
09/16
18:25
09/16/19
18:25
Conference/Events
iCAD to hold an investor reception »

Management hosts "An…

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

  • 16

    Sep

  • 12

    Nov

GLW

Corning

$30.04

-0.12 (-0.40%)

18:18
09/16/19
09/16
18:18
09/16/19
18:18
Hot Stocks
Corning down 5.5% or $1.64 at $28.40 per share after cutting volume outlook »

As part of the…

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

WE

We Company

$0.00

(0.00%)

18:17
09/16/19
09/16
18:17
09/16/19
18:17
Periodicals
We Company IPO delayed until October at earliest, WSJ reports »

The We Company's IPO…

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

GLW

Corning

$30.04

-0.12 (-0.40%)

18:16
09/16/19
09/16
18:16
09/16/19
18:16
Hot Stocks
Corning cuts Q3 volume guidance for Display and Optical Communications units »

Corning is providing the…

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

WE

We Company

$0.00

(0.00%)

18:05
09/16/19
09/16
18:05
09/16/19
18:05
Periodicals
Breaking Periodicals news story on We Company »

We Company IPO delayed…

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

GM

General Motors

$37.21

-1.62 (-4.17%)

18:02
09/16/19
09/16
18:02
09/16/19
18:02
Periodicals
Auto workers strike could cost GM $100M daily, WSJ says »

General Motors could lose…

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

HLNE

Hamilton Lane

$59.95

-0.51 (-0.84%)

17:57
09/16/19
09/16
17:57
09/16/19
17:57
Hot Stocks
Hamilton Lane vice chairman sells 150K shares of common stock »

In a regulatory filing,…

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

  • 26

    Sep

17:52
09/16/19
09/16
17:52
09/16/19
17:52
Conference/Events
SVB Leerink biotech analysts to hold analyst/industry conference call »

Biotech Analysts discuss…

HLNE

Hamilton Lane

$59.95

-0.51 (-0.84%)

17:52
09/16/19
09/16
17:52
09/16/19
17:52
Hot Stocks
Hamilton Lane chairman sells 78.5K shares of common »

In a regulatory filing,…

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

  • 26

    Sep

GD

General Dynamics

$190.91

0.98 (0.52%)

, BAH

Booz Allen

$70.35

0.85 (1.22%)

17:44
09/16/19
09/16
17:44
09/16/19
17:44
Hot Stocks
General Dynamics, Booz Allen and Parsons awarded $427M max Air Force contract »

General Dynamics (GD),…

GD

General Dynamics

$190.91

0.98 (0.52%)

BAH

Booz Allen

$70.35

0.85 (1.22%)

PSN

Parsons

$37.25

0.35 (0.95%)

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

    Oct

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.