Merck's Recarbrio Gets FDA Priority Review For New Indication

Merck & Co. (NYSE: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%.

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 currently has a Zacks Rank #3 (Hold).

A few better-ranked stocks from the healthcare space are Pfizer, Inc. (NYSE:PFE) , Sanofi (NASDAQ:SNY) and Roche Holding (SIX:ROG) AG (OTC: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.

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