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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.

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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).

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TER

Teradyne

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-0.83 (-1.38%)

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LEVI

Levi Strauss

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BNY Mellon

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Wells Fargo

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FMBI

First Midwest

$20.13

0.11 (0.55%)

17:42
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Earnings
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GVA

Granite Construction

$36.76

0.44 (1.21%)

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REZI

Resideo

$15.17

0.03 (0.20%)

, STZ

Constellation Brands

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2.055 (1.06%)

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REZI

Resideo

$15.17

0.03 (0.20%)

STZ

Constellation Brands

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2.055 (1.06%)

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SNAP

Snap

$14.00

-0.58 (-3.98%)

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Snap says average revenue per user was $2.12 in Q3, an increase of 33% y-o-y »

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KFS

Kingsway Financial

$2.23

-0.045 (-1.98%)

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REZI

Resideo

$15.17

0.03 (0.20%)

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Resideo begins comprehensive operational and financial review »

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REZI

Resideo

$15.17

0.03 (0.20%)

17:27
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17:27
Earnings
Resideo cuts FY19 revenue growth view to 2%-4% from 2%-5%, consensus $5.02B »

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REZI

Resideo

$15.17

0.03 (0.20%)

17:26
10/22/19
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17:26
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17:26
Earnings
Resideo reports preliminary Q3 revenue $1.226B, consensus $1.25B »

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HNGR

Hanger

$20.50

0.39 (1.94%)

, RTEC

Rudolph Technologies

$27.36

-0.12 (-0.44%)

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Hanger to replace Rudolph Technologies in S&P 600 at open on 10/28 »

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HNGR

Hanger

$20.50

0.39 (1.94%)

RTEC

Rudolph Technologies

$27.36

-0.12 (-0.44%)

NANO

Nanometrics

$34.01

0.03 (0.09%)

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PSB

PS Business Parks

$184.20

-1.53 (-0.82%)

17:11
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Earnings
PS Business Parks reports Q3 FFO $1.71, two estimates $1.73 »

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EPSN

Epsilon Energy

$3.20

(0.00%)

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Epsilon Energy CEO comments on recent well results »

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CALX

Calix

$7.15

0.005 (0.07%)

17:06
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Earnings
Calix sees Q4 non-GAAP EPS 6c-10c, consensus 11c »

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  • 23

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NOW

ServiceNow

$228.26

-12.315 (-5.12%)

17:05
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Breaking Hot Stocks news story on ServiceNow »

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CALX

Calix

$7.15

0.005 (0.07%)

17:05
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Earnings
Calix reports Q3 non-GAAP EPS 6c, consensus 4c »

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  • 23

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GSS

Golden Star Resources

$2.99

0.05 (1.70%)

17:04
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Golden Star Resources to move corporate office, CFO Andre van Niekerk to leave »

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  • 31

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TER

Teradyne

$59.24

-0.83 (-1.38%)

17:03
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Earnings
Teradyne reports Q3 adjusted EPS 77c, consensus 70c »

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UCBI

United Community Banks

$29.30

0.12 (0.41%)

17:02
10/22/19
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17:02
Earnings
United Community Banks reports Q3 adjusted EPS 63c, consensus 58c »

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NEM

Newmont Goldcorp

$37.80

-0.17 (-0.45%)

17:01
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  • 05

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ATR

AptarGroup

$116.78

-1.22 (-1.03%)

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BUSE

First Busey

$25.45

0.05 (0.20%)

17:01
10/22/19
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Earnings
First Busey reports Q3 adjusted EPS 55c, consensus 52c »

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  • 13

    Nov

SNAP

Snap

$14.00

-0.58 (-3.98%)

17:01
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Snap says each daily active user opens Snapchat 30 times per day on average »

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SMH

Market Vectors Semiconductor

$123.51

-0.88 (-0.71%)

, TXN

Texas Instruments

$128.61

-2.32 (-1.77%)

16:57
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Hot Stocks
Semiconductor stocks fall after Texas Instruments gives dismal outlook »

Shares of Market Vectors…

SMH

Market Vectors Semiconductor

$123.51

-0.88 (-0.71%)

TXN

Texas Instruments

$128.61

-2.32 (-1.77%)

INTC

Intel

$52.00

-0.12 (-0.23%)

QCOM

Qualcomm

$78.46

-0.5 (-0.63%)

TSM

TSMC

$50.66

0.65 (1.30%)

AVGO

Broadcom

$287.54

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NVDA

Nvidia

$195.52

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ASML

ASML

$255.32

-5.14 (-1.97%)

ADI

Analog Devices

$110.91

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LRCX

Lam Research

$234.91

-3.77 (-1.58%)

AMD

AMD

$31.51

-0.54 (-1.68%)

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