InvestorsHub Logo
Followers 3
Posts 164
Boards Moderated 0
Alias Born 03/10/2011

Re: None

Monday, 06/06/2016 2:17:57 PM

Monday, June 06, 2016 2:17:57 PM

Post# of 372
It turns out that Relypsa Inc. (NASDAQ:RLYP) largest institutional shareholders are buying more stock as news coming out of the company is turning more bullish.

While Relypsa Inc. is often caught up in takeover rumors surrounding firms from AstraZeneca (NYSE:AZN), to Merck (NYSE:MRK), Biogen (NASDAQ:BIIB), Pfizer Inc. (NYSE:PFE) and its partner Sanofi (NYSE:SNY), recently the stock is up on real news.

First, on May 23rd Relypsa, Inc. rose on new data that the company presented surrounding its drug Veltassa which showed the following:

“Patients with heart failure and chronic kidney disease often have restricted fluid and sodium intake, as these may cause congestive symptoms.

We presented new data suggesting Veltassa may bind and remove sodium as well as potassium in the gastrointestinal tract, which may be relevant for these patients.”

Source: GlobeNewswire

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).

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

Second, and most urgently, Relypsa' s only competitor in the Hyperkalemia space, AstraZeneca's acquired ZS-9, was given a complete response letter (CRL) from the FDA, which in English means, a full rejection of the filing for approval.

The CRL surrounded manufacturing issues with ZS-9, not clinical data. However, that CRL will push the ZS-9 product launch out at least another year and the drug still has issues surrounding its tendency to create sodium in the blood, which is a critical side effect for patients that have Hyperkalemia and may mean the drug will be prevented from treating the largest portion of the market -- chronic cases.

Hopes have now crept in that the ZS-9 drug, if it gets approved, will get 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.

But now we got more news on Relypsa.

INSTITUTIONS ARE BUYING
The good news surrounding Relypsa Inc. has pushed the stock up 40% in recent weeks and the buying appears to be coming from the company's largest institutional shareholders.

While the largest shareholder, Orbimed, saw no change, the next seven largest holders increased their holdings. In total, of the eleven largest holders, eight bought more stock, two sold stock and one was unchanged. The result is an increase of nearly 3.2 million shares on a total stock float of just 31.8 million shares. Institutional shareholders own more than 85% of the Relypsa, Inc. stock as of this writing, and 11% is held by insiders.