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Merck's Recarbrio Gets FDA Priority Review for New Indication
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Merck & Co. (MRK - Free Report) 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%.
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.
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.
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Merck's Recarbrio Gets FDA Priority Review for New Indication
Merck & Co. (MRK - Free Report) 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%.
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. 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 - Free Report) , Sanofi (SNY - Free Report) and Roche Holding AG (RHHBY - Free Report) . 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 >>