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.
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.
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.
Each company in our "Top Picks" is the single winner in an exploding thematic shift like biotech, artificial intelligence, Internet of Things, drones, and more. In fact, here are just two of the trends that will radically affect the future that we are ahead of:
The Internet of Things (IoT) market will be measured in trillions of dollars as of next year. CML Pro has named the top two companies that will benefit. Then there's cyber security:
Market correction or not, recession or not, the growth in this area is a near certainty, even if projections come down, this is happening. CML Pro has named the single best cyber security stock to benefit from this theme.
These are just two of the themes we have identified and this is just one of the fantastic reports CML Pro members get along with all the visual tools, the precious few thematic top picks for 2016, research dossiers and alerts. For a limited time we are offering CML Pro at a 90% discount for $10/mo. with a lifetime guaranteed rate. Join Us: Get the most advanced premium research delivered to your inbox along with access to visual tools and data that until now has only been made available to the top 1%.
Thanks for reading, friends.
Please read the legal disclaimers below and as always, remember, we are not making a recommendation or soliciting a sale or purchase of any security ever. We are not licensed to do so, and we wouldn’t do it even if we were. We're sharing my opinions, and provide you the power to be knowledgeable to make your own decisions.
Legal The information contained on this site is provided for general informational purposes, as a convenience to the readers. The materials are not a substitute for obtaining professional advice from a qualified person, firm or corporation. Consult the appropriate professional advisor for more complete and current information. Capital Market Laboratories ("The Company") does not engage in rendering any legal or professional services by placing these general informational materials on this website.
The Company specifically disclaims any liability, whether based in contract, tort, strict liability or otherwise, for any direct, indirect, incidental, consequential, or special damages arising out of or in any way connected with access to or use of the site, even if we have been advised of the possibility of such damages, including liability in connection with mistakes or omissions in, or delays in transmission of, information to or from the user, interruptions in telecommunications connections to the site or viruses.
The Company makes no representations or warranties about the accuracy or completeness of the information contained on this website. Any links provided to other server sites are offered as a matter of convenience and in no way are meant to imply that The Company endorses, sponsors, promotes or is affiliated with the owners of or participants in those sites, or endorse any information contained on those sites, unless expressly stated.