Market Overview

AstraZeneca Remains Committed To Development Of ZS-9 Despite Letter From FDA

AstraZeneca Remains Committed To Development Of ZS-9 Despite Letter From FDA

Shares of AstraZeneca plc (ADR) (NYSE: AZN) were trading lower by more than 1.5 percent early Friday after the company confirmed it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration relating to its New Drug Application (NDA) for sodium zirconium cyclosilicate, also known as ZS-9.

ZS-9 is an investigational medicine produced by ZS Pharma, a fully-owned subsidiary AstraZeneca. The medicine is intended for the treatment of hyperkalaemia or high potassium level in the blood serum.

The CRL refers to observations the governmental agency made in a pre-approval manufacturing inspection. However, the letter does not imply that AstraZeneca must submit new clinical data.

Related Link: AstraZeneca's ZS-9 Delay Highlights Broader Risk Of Pipeline-Led EPS Growth Outlook

"AstraZeneca remains committed to the development of sodium zirconium cyclosilicate as a treatment option for patients with hyperkalaemia," the company said in its press release. "Interactions are ongoing with other health authorities in the European Union and Australia, where sodium zirconium cyclosilicate is currently under separate regulatory review."

Finally, AstraZeneca noted it's working with its subsidiary to evaluate the content of the letter and will also work closely with the FDA to determine the appropriate steps needed for the NDA.

Shares traded recently at $29.49, down 1.54 percent in the pre-market session.

Posted-In: AstraZeneca FDA Complete Response Letter Hyperkalemia New Drug ApplicationNews Health Care FDA General


Related Articles (AZN)

View Comments and Join the Discussion!
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.
Daily Analyst Rating
A summary of each day’s top rating changes from sell-side analysts on the street.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
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