ARDX's Upcoming PDFA in CKD

What is the readout? FDA approval decision deadline date (PDUFA) for tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis

Timing (estimate) of readout:

PDUFA date (FDA target deadline date) April 29, 2021

What is success?

Approval by the FDA

What are our thoughts on this PDUFA:

There is a very good chance of approval on this first FDA review for serum phosphorus control, although with FDA delays recently, there is less certainty that the FDA will hit the April 29, 2021 target date. Furthermore, the effect of approval on the stock is hard to predict: Our Big-Mover analysis indicates that the market thinks it is likely that this stock will move at least 20% up or down. However, the stock has already gained more than 20% from its late March lows and current volatility may be reflecting that. Whether ARDX can quickly ramp revenue to over the $100M/annual level, seems unlikely given the pandemic and the challenge of launching into a market without an established sales force, and with lots of relatively low price options. Of course, the hard-to-predict wild card here is a possible acquisition of ARDX, especially by a company that already has a sales force that calls on nephrologists. The timing and likelihood of acquisition are hard to predict, and thus we don't buy a stock on the possibility of an acquisition.

So are we buying or selling into this PDUFA? Check out our decision and lots more comments for and against investing in ARDX ahead of the PDUFA at our forum post about it. You need a free 30-day trial signup (no credit card required) to access the article. Just go to and follow the links.