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Merck (MRK) Gets Priority Tag for Antiviral Drug Prevymis sNDA

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Merck (MRK - Free Report) announced that the FDA has accepted and granted priority review to a supplemental new drug application (sNDA) seeking expanded use of its antiviral medicine, Prevymis. The sNDA seeks approval for Prevymis for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk. The FDA is expected to give its decision on the sNDA on Jun 5, 2023.

Prevymis is presently approved for the prevention of clinically-significant CMV infection in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT). 

The FDA also accepted another sNDA to allow the extended use of Prevymis from 100 days to 200 days in adults receiving an HSCT who are at risk of late CMV infection. The decision on this sNDA is expected on Sep 7, 2023.

Merck’s stock has risen 43.5% in the past year compared with the industry’s increase of 11.8%.

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Prevymis recorded sales of $428 million, up 16% year over year. Prevymis is part of Merck’s Hospital Acute Care segment.

Zacks Rank & Stocks to Consider

Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked large drug stocks include Novartis (NVS - Free Report) , Roche (RHHBY - Free Report) and Novo Nordisk (NVO - Free Report) . Novo Nordisk has a Zacks Rank of 1 (Strong Buy), while Roche and Novo Nordisk have a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for Novartis’ 2023 earnings per share have increased from $6.44 to 6.51 in the past 60 days, while the same for 2024 have gone up from $6.92 to $6.96 in the same time frame. Novartis’ stock has risen 0.8% in the past year.

Novartis beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 2.92%, on average.

In the past 60 days, estimates for Novo Nordisk’s earnings per share for 2023 have increased from $4.03 to $4.20, while the same for 2024 has gone up from $4.61 to $4.90 in the same time frame. Shares of Novo Nordisk have risen 40.5% in the past year.

Novo Nordisk beat earnings expectations in three of the trailing four quarters while missing in one. The company delivered a four-quarter earnings surprise of 3.0%, on average.

In the past 60 days, estimates for Roche’s earnings per share for 2024 have increased from $2.79 to $2.82. Shares of Roche have declined 18.3% in the past year.

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