FMP

FMP

Ardelyx Down 17%, FDA Probably Won’t Approve tenapanor

Ardelyx, Inc. (NASDAQ:ARDX) shares were trading around 17% lower on Wednesday as the company is still struggling to find common ground with FDA concerning tenapanor.

The company completed its Type A meeting with the FDA on Oct 1, the key takeaway from which is that the company doesn’t have a better understanding of FDA's concerns on how to define tenapanor's clinical significance and what constitutes a relevant treatment effect.

Analysts at Wedbush provided their view on the situation, mentioning that they believe FDA is unwilling to approve tenapanor and doesn't seem interested in even supplying a framework to do so. As a result, the analysts update their model to remove tenapanor credit entirely and lower their price target on the company’s shares to $1 from $2.