Market Overview

Ahead Of Merck's Keytruda PDUFA Date, Analyst Says Expect Approval

Ahead Of Merck's Keytruda PDUFA Date, Analyst Says Expect Approval

Merck & Co., Inc. (NYSE: MRK) traders that haven't already done so should mark May 10 on their calendars. The company announced in early January the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab).

A Priority Review has been granted with a date set for next Wednesday.

Keytruda is a therapy used for the treatment of patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC).

BMO: Expect Keytruda Approval

Merck also reported its first quarter results Tuesday, which BMO Capital Markets' Alex Arfaei described as "cautious." However, after taking a deep-dive into the report, the analyst became "more comfortable" with the results after the earnings conference call.

The analyst noted Januvia's miss in the quarter was "explainable" and driven by a $70 million purchase timing adjustment. Also, Zepatier's ex-U.S. launch is off to a better than expected start, vaccines performed well, and animal health was once again strong due to Bravecto.

Looking forward, Arfaei believes the "most important" upcoming event for Merk is the May 10 PDUFA date for Keytruda. The analyst is assigning an 80 percent likelihood of approval given its excellent efficacy and good safety profiles.

"We believe Merck is in a strong position to lead in IO with Keytruda monotherapy, combination with chemo, as well as in combination with INCY's Epacadostat for which we will likely see positive data at ASCO 2017, and soon its own secondary IO's," the analyst wrote.

Finally, Arfaei said Merck's primary growth driver through 2017 will be Keytruda, followed by a ramp-up in Zepatier. The company expects these two therapies to be a meaningful contributor in the bottom half of 2017 and the analyst's Keytruda sales estimate of $3.9 billion is even ahead of the consensus estimate of $3.5 billion.

See Also:

Merck's Keytruda Gains Momentum At The Expense Of Bristol-Myers

Everything We Know About Merck's Keytruda

Latest Ratings for MRK

Jul 2019Initiates Coverage OnBuy
Jun 2019MaintainsOverweight
Jun 2019MaintainsOverweight

View More Analyst Ratings for MRK
View the Latest Analyst Ratings

Posted-In: Alex Arfaei BMO Capital Markets Januvia Keytruda Merk ZEPATIERAnalyst Color Analyst Ratings Best of Benzinga


Related Articles (MRK)

View Comments and Join the Discussion!

Latest Ratings

BCELInitiates Coverage On23.0
View the Latest Analytics Ratings
Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Trading Daily
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Daily Analyst Rating
A summary of each day’s top rating changes from sell-side analysts on the street.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at

Contrarian View: Buy U.S. Steel Following 'Abysmal' Q1

Mid-Afternoon Market Update: Lantheus Rises After Strong Q1 Results; Veritiv Shares Slide