Biotech Analysis Central Preview Series: Ardelyx, Inc.

This is a preview blog series on what you can expect when subscribing to my "Biotech Analysis Central" service marketplace. For the full article you must subscribe to my service. This is just an intro of two snippets on the research articles that are written. Thus far, there are about 100+ research reports on both both small-cap and mid-cap biotech stocks with full analysis of the pipeline, catalysts, financials, and clinical trial analysis. If you want to read more then please subscribe to my marketplace service. As always I offer a 2-week free trial just to show you how helpful my service is. You can cancel anytime before the 2-week free trial is up and never be charged a dime.

First Section Of Marketplace Article (This article piece was originally written on June 27, 2020)

For this Biotech Analysis Central Update Series I wanted to go over again a biotech by the name of Ardelyx, Inc. (ARDX). The reason why I wanted to go over this biotech next is because it is gearing up to submit its New Drug Application (NDA) to the FDA in mid-2020 for its drug tenapanor. This drug is being developed to treat patients with Chronic Kidney Disease (CKD) and those who are on dialysis. The thing though is that it is purely helping these patients out in terms of serum phosphorus levels. Additional updated data from both phase 3 AMPLIFY AND PHREEDOM studies are anticipated at upcoming medical conferences. Recent results from the phase 4 NORMALIZE study using tenapanor to treat these patients had already been revealed back in December of 2019. With all these studies being positive, that's why Ardelyx is able to move forward toward filing an NDA any time now in mid-2020. It also intends to initiate another study in 2020, for this patient population, known as OPTIMIZE. The goal of this study is to see real world practice of tenapanor in helping serum phosphorus levels for these CKD patients who are on dialysis.

Conclusion Of Marketplace Article

The Final Verdict is that Ardelyx is a good speculative biotech to look into. It has received FDA approval for IBS-C with IBSRELA, but it needs to still find partners to help commercialize it. The global IBS market is large, because it is expected to reach $3.3 billion by 2026. The competition is pretty strong in the IBS-C space and it will need lots of financial backing to increase its sales. That's why I think it is more prudent for it to seek a partner to help improve U.S. sales of the drug. It has its partner for Canada known as Knight Therapeutics, so that's a good start. I believe that the NDA filing in mid-2020 for tenapanor in CKD patients on dialysis will move the stock. The main issue comes from whether or not IBSRELA sales continue to improve or weaken in the coming quarters. That's why I'm stating that Ardelyx is a good speculative biotech to look into. I need to see tangible evidence that it is not only meeting its sales goals for IBSRELA, but beating expectations by large margins. Even then, it is good that the biotech is able to shift over to the CKD market, for those who are on dialysis. This is another multi-billion dollar market. The global chronic kidney disease (CKD) market is expected to reach $16.8 billion by 2025. Even with only a subset of those who are on dialysis, about 500,000 to 1 million people, it is still a large market to help. The good thing about Ardelyx is that its technology platform provides a way to help reduce the amount of pills that these patients have to take. That is a good competitive advantage to have. If things go well with the NDA for tenapanor in patients with CKD on dialysis, then I believe Ardelyx can definitely become a good long-term biotech to own.