Advertisement
UK markets closed
  • FTSE 100

    7,952.62
    +20.64 (+0.26%)
     
  • FTSE 250

    19,884.73
    +74.07 (+0.37%)
     
  • AIM

    743.26
    +1.15 (+0.15%)
     
  • GBP/EUR

    1.1704
    +0.0010 (+0.09%)
     
  • GBP/USD

    1.2639
    +0.0017 (+0.14%)
     
  • Bitcoin GBP

    55,471.07
    -1,131.58 (-2.00%)
     
  • CMC Crypto 200

    885.54
    0.00 (0.00%)
     
  • S&P 500

    5,254.35
    +5.86 (+0.11%)
     
  • DOW

    39,807.37
    +47.29 (+0.12%)
     
  • CRUDE OIL

    83.11
    -0.06 (-0.07%)
     
  • GOLD FUTURES

    2,254.80
    +16.40 (+0.73%)
     
  • NIKKEI 225

    40,369.44
    +201.37 (+0.50%)
     
  • HANG SENG

    16,541.42
    +148.58 (+0.91%)
     
  • DAX

    18,492.49
    +15.40 (+0.08%)
     
  • CAC 40

    8,205.81
    +1.00 (+0.01%)
     

Merck's Recarbrio Gets FDA Priority Review for New Indication

Merck & Co. MRK announced that the supplemental new drug application (sNDA) seeking approval of its new antibacterial injection Recarbrio for a new indication has been accepted by the FDA. The sNDA has been filed to get Recarbrio approved to treat adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms. With the FDA granting a priority review to the sNDA, a decision is expected on Jun 4, 2020.

Recarbrio is a fixed combination of relebactam and imipenem/cilastatin. Recarbrio was approved for the treatment of adults with complicated urinary tract infections and complicated intra-abdominal bacterial infections caused by certain susceptible gram-negative bacteria in July last year.

The sNDA submission is based on the results of the pivotal phase III RESTORE-IMI 2 study.

Shares of the company have gained 13.6% in the past year compared with the industry’s growth of 10.9%.

 

ADVERTISEMENT

In a separate release, the company announced that the FDA approved updating the label of its insomnia drug Belsomra (suvorexant) C-IV to include data from a study, evaluating the drug for the treatment of insomnia in people with mild-to-moderate Alzheimer’s disease dementia. Belsomra is presently approved to treat insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

The update is based on the data from a multi-site 4-week polysomnography study, in which Belsomra demonstrated a statistically significant improvement in both Total Sleep Time (TST) and Wake After Sleep Onset (WASO) measures compared to those treated with placebo, as assessed objectively by polysomnography.

 

Merck & Co., Inc. Price

 

Merck & Co., Inc. Price
Merck & Co., Inc. Price

 

Merck & Co., Inc. price | Merck & Co., Inc. Quote

Zacks Rank and Stocks to Consider

Merck currently has a Zacks Rank #3 (Hold).

A few better-ranked stocks from the healthcare space are Pfizer, Inc. PFE, Sanofi SNY and Roche Holding AG RHHBY. While Pfizer sports a Zacks Rank #1 (Strong Buy), Sanofi and Roche carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Pfizer’s earnings per share estimates have moved up from $2.62 to $2.77 for 2020 and from $2.73 to $2.81 for 2021 in the past 90 days. The company delivered a positive earnings surprise of 7.46%, on average, in three of the last four quarters.

Sanofi’s earnings per share estimates have moved up from $3.26 to $3.29 for 2019 and from $3.45 to $3.49 for 2020 in the past 60 days. The company delivered a positive earnings surprise of 8.25%, on average, in the last four quarters.

Roche’s earnings per share estimates have increased from $2.61 to $2.66 for 2020 in the past 60 days.

7 Best Stocks for the Next 30 Days

Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers “Most Likely for Early Price Pops.” Since 1988, the full list has beaten the market more than 2X over with an average gain of +24.7% per year. So be sure to give these hand-picked 7 your immediate attention.

See 7 handpicked stocks now >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Pfizer Inc. (PFE) : Free Stock Analysis Report
 
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
 
Roche Holding AG (RHHBY) : Free Stock Analysis Report
 
Sanofi (SNY) : Free Stock Analysis Report
 
To read this article on Zacks.com click here.