Skip to main content

Market Overview

Incyte PDUFA Date Pushed Back, JMP Discusses Impact

Share:
Incyte PDUFA Date Pushed Back, JMP Discusses Impact

There has been a three-month delay in the Food and Drug Administration Prescription Drug User Fee Act date for Incyte Corporation (NASDAQ: INCY)'s partnered rheumatoid arthritis drug, baricitinib. The U.S. approval and launch of the drug is now expected in Q2 2017, JMP Securities analysts said in a report. They reiterated a Market Outperform rating on the company, with a price target of $130.

The PDUFA allows the FDA to collect fees from drug manufacturers to fund the new drug approval process. The FDA has pushed the new PDUFA date for baricitinib to April. Incyte’s partner for this drug, Eli Lilly and Co (NYSE: LLY), has submitted additional data for analysis.

Impact Of Delay

Meanwhile, the PDUFA date for competitor Xeljanz (tofacitinib) from Pfizer Inc. (NYSE: PFE) for the same indication has been delayed for safety reasons.

“We continue to anticipate approval [for baricitinib] is forthcoming, but will be postponed by three months as we await the FDA to review the new data,” the analysts wrote. They added, “The delay is immaterial to our price target as the postponed royalty is small.”

There is a milestone of $100 million associated with the approval. However, the delay is only for three months and is partially offset by a milestone of $30 million for psoriatic arthritis.

“Our thesis on the shares of INCY remains intact and we recommend buying shares on weakness as we expect tremendous value creation through the development of the oncology pipeline and opportunistic indications,” the JMP report noted.

In Tuesday's pre-market session, shares of Incyte were seen down 0.85 percent at $116.75.

Latest Ratings for INCY

DateFirmActionFromTo
Feb 2021Morgan StanleyMaintainsEqual-Weight
Feb 2021SVB LeerinkDowngradesMarket PerformUnderperform
Jan 2021Truist SecuritiesInitiates Coverage OnBuy

View More Analyst Ratings for INCY
View the Latest Analyst Ratings

 

Related Articles (INCY)

View Comments and Join the Discussion!

Posted-In: Analyst Color Biotech Long Ideas News Health Care Reiteration FDA Analyst Ratings Best of Benzinga

Latest Ratings

StockFirmActionPT
FSRMorgan StanleyMaintains40.0
NATJefferiesMaintains2.8
MEDDA DavidsonMaintains302.0
VICRBWS FinancialMaintains120.0
PSXMizuhoMaintains96.0
View the Latest Analytics Ratings
Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
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.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
SPAC
Everything you need to know about the latest SPAC news.
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 vipaccounts@benzinga.com