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PREFACE
While Relypsa is often caught up in takeover rumors surrounding firms from AstraZeneca (NYSE:AZN), to Merck (NYSE:MRK) and its partner Sanofi (NYSE:SNY), today the stock is up on real news.


This article was originally published to news.cmlviz.com

Relypsa, Inc. (NASDAQ:RLYP) is rising today, up more than 13%, on new data presented surrounding its drug Veltassa. Further, Relypsa's biggest competitor, AstraZeneca's ZS-9 drug candidate, will have its FDA decision date (PDUFA) this week on Thursday.

STORY
Relypsa, Inc. stock is rising today for two reasons. First, hopes have now crept in that the ZS-9 drug will get an approval with a black box warning surrounding its side effect of creating sodium in the blood. The black box is the harshest warning the FDA can issue.

Second and rather conveniently, new data from Relypsa that was presented at the European Renal Association shows that its drug, Veltassa, actually reduces sodium in the blood.

Here are the results Relypsa presented at the European Renal Association, delivered by Lance Berman, M.D., chief medical officer of Relypsa, Inc.


The new data revealed that:
* Daily administration of Veltassa resulted in a dose-related decrease in mean urine sodium compared with placebo (p=0.009 across Veltassa doses).

* The most common adverse events were gastrointestinal events that were mild or moderate in severity.

* No serious adverse events were reported, and no study participants discontinued treatment because of an adverse event.

CONCLUSION
That first bullet point (Daily administration of Veltassa resulted in a dose-related decrease in mean urine sodium) is the critical result.

Relypsa is already taking a competitive stance against ZS-9 before the drug has even been approved. If the FDA issues a black box warning surrounding sodium from ZS-9, Relypsa stock could spike much higher.

But, please read this -- if the FDA does not issue a warning on ZS-9, Relypsa stock could drop substantially.

The author is long Relypsa call options in his personal account.

SEEING THE FUTURE
There's so much going on with Relypsa we can't cover it all in one report but it is one of the few precious "Top Picks" named by CML Pro.

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Thanks for reading, friends.


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