topgun - more players are in this over $30/shr (tutes) and they will have a say but I would agree with a $2B BO which will pretty much cover ALL bigger owners cost + some gains. $46-$50 will avoid lawsuits etc. Selling for $28/shr is $1.25B or so and that would be a scam!
gamebirdy - For me, your post sums it up. this kind of comment should be posted by some of our loyal Analysts that have a clue. The hill that was once there for ZS-9 has now become a mountain for a variety of reasons. This drug would have to be equal, if not greater, than Veltassa but it is actually inferior. So, why should it be approved with possible negative patient impact? Also, maybe the data was ZS004E's but why would they (AZN) have waited so long to send to the FDA? As for Veltassa, the positives keep coming with the additional studies/trials. BP should be seeing ALL that has occurred. The only real issue that remains (besides RLYP's financing) is assessing the CKD/HK market's size (which goes beyond that market per PAH and other results) for Veltassa AND SALES reach. Get rid of Sanofi now and pay off VIFOR (Galenica) and you (BP) own the whole USA/ROW market. Huge opportunity!!! thx
New data was from/for the manufacturing issue/correction (per FierceBIO/AZN). So, the extension of ZS005 was not even discussed/mentioned. Those 2 new trials in November could have been for this issue?? Not sure but either way - CRL. They sure as heck did not just find out about this in the last few weeks.
Agree - now is the time with the separation between any competition and all the other DUCKS (see checklist 2016) are in a row. Next week should produce some REAL noise
Launch Veltassa (check)
Secure $45M at the ATM (check) YUCK1
Complete Phase I DDI trial and report (check)
Veltassa gets covered by most insurance plans (check)
Have Veltassa added to Medicare Formulary (CHECK)
Report monthly on Scripts (check)
Insiders purchase shares (check)
Tutes add in 1st Quarter (over 2M shares) (check)
File MAA in the EU for Veltassa approval (VF) (check)
Secure more financing of $150M to get into 2017 (check) - YUCK2
File sNDA with FDA to change label BB from 6 hrs (check)
Report on other trial's progress/successes (check)
ZS-9 does NOT get approved May 26th - delayed 9-16 months) CHECK!!!
And the PPS is barely $18? YUCK3
Have a good weekend/holiday everyone and feel free to add to the checklist!!!
And these indexes still loom heavy over BIOs. Nasdaq is looking better but that did little for us today!
anton - almost 15M shares traded and EVERYONE but a few lately lost today. Cracker Box Palace - we were expecting this - the CLOWN show continues
AstraZeneca is suddenly finding out how it feels to be the underdog.
"Until Friday, AstraZeneca looked smart for its November purchase of ZS Pharma and its potential blockbuster hyperkalemia drug ZS-9. Relypsa, which has a competing drug on the market, looked in trouble. Though its treatment for the blood condition was approved in October, it's saddled with restrictive FDA guidelines and slow sales growth. The company's high cash burn rate led it to take out $150 million in loans in April, expensively.
All that changed early Friday morning, when AstraZeneca announced the FDA had rejected ZS-9. Relypsa is remembering how to enjoy life again, and AstraZeneca may be diverting scientists into time-machine research.
It looks like AstraZeneca may have shelled out too early and on the wrong company. Relypsa, in contrast, may be back on the blockbuster track and back to being an acquisition target. Relypsa's shares spiked as much as 27 percent Monday morning, while AstraZeneca's dropped as much as 1 percent.
The FDA declined to approve ZS-9 after finding issues in a manufacturing inspection. The agency also said it hasn't reviewed some of AstraZeneca's data on the drug. The company is working to figure out next steps and will try again for approval, but the lack of a timeline makes things unpredictable. Resolving the agency's issues and getting a new approval date may take a year or more. And the FDA could still reject the drug again based on its clinical data.
Until Friday, analysts expected ZS-9 to outsell Relypsa's drug Veltassa by nearly $100 million in 2020. That was based partly on expectations AstraZeneca's drug, unlike Veltassa, could be approved without a so called "black box" warning label -- the FDA's strictest warning -- or to treat a broader group of patients. etc.
Relypsa's woes have made it less attractive to potential acquirers. Any buyer will likely want to see some improvement in Veltassa's sales trends, or may wait for more ZS-9 clarity. etc."
To me that is remarkable that so many of these BUYERS (include me) are so stupid to buy in the $18.80's and above. Think of all those 2m+ who traded above $21? Day traders pretty much lost except for those who bought below $18.50. Thank you Hedgies , Berens/MS and those 14M SI clowns!!!
gamebirdy - in November, they removed the DMC (Data monitoring Committee) from this trial AFTER the interim results in early November showed SAE concerns. Not sure why AZN/ZSPH would do that or if the FDA suggested that??? Now in May another change and extension. But all the CRL was for was "manufacturing". Yep, that's the ticket. Slam dunk best in class ZS-9 LOL
The attack has been occurring since way above $19 and then we traded over 2M shrs between $18.80 and $19. NOW they have it down to between $18.50 and $18.70. All decent BIDS get scooped up and then the PPS goes lower. BIOs doing almost nothing today which does not help. Very disappointing and very manipulated.
This biopharmaceutical company also has been hammered but has big upside potential, according to the Stifel analyst. Relypsa Inc. (NASDAQ: RLYP) is focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract.
The company’s first medicine, Veltassa (patiromer) for oral suspension, was developed based on Relypsa’s rich legacy in polymer science. Veltassa is approved in the United States for the treatment of hyperkalemia. Veltassa has intellectual property protection until 2030 in the United States and 2029 in the European Union.
In a huge win for the company, and a big surprise for many, AstraZeneca’s competing drug to Veltassa, ZS-9, which many thought would gain approval but have a severe black box warning, was not approved by the U.S. Food and Drug Administration (FDA). This incredible and unexpected setback is fantastic news for Relypsa. With AstraZeneca out of the game for now, Relypsa has the commercial market, with estimated peak sales forecasts of about $1 billion, all to itself.
Relypsa also announced this week that the company has submitted a supplemental New Drug Application (sNDA) to the FDA requesting label changes for Veltassa for oral suspension based on results of 12 Phase 1 drug-drug interaction studies in healthy volunteers.
Stifel has a huge $36 price target for the stock, while the consensus price objective is $31.33. The stock closed Thursday at $16.60 but opened Friday at $20.63, up more than 20%.
thx kwarter but I will defer to Whitecoatmafia, Lurker, (even Golong if he ever smiles), the PIRATE, yourself and a few others who have recently joined or started posting well thought out ideas - both ways. Have to admit sometimes I felt pretty STUPID LOL
I thought a CRL was possible but I never believed ZS-9 would be approved except for nominal use (short term - maybe 10 days) awaiting further data. BB probably for DDI, HP and Edema. This CRL news is frosting on this sodium cake and the FDA has made a very underappreciated statement to BP and the market. The FDA did the right thing here (all agree) and we should not have ZS-9 concerns for at least 9 months (or ????). For those who are adamant that Relypsa sells - I 90% agree as the timing is right and if we all want Veltassa to become SOC for this (and other diseases), another BP would do much better. Today's trading may be pushed lower by the MM's working for the Hedgies who got caught. Berens MAY stay quiet until his clients are totally out!!
NICE - They had just added/bought 973K shares in the 1st Qtr:
DEERFIELD MANAGEMENT CO 03/31/2016 1,873,471 973,190
So, with 2.36M+ they have added another 350K+ in April/May, to their holdings since 3/31. WHY?
here she is (says ZS-9 will go well into 2017!!!):
"Mizuho analyst Irina Koffler is re-evaluating her Underperform rating and $12 PT on Relypsa (NASDAQ: RLYP) after AZN announced receipt of a CRL for its ZS-9 zirconium silicate NDA, with a delay that we expect to persist well into 2017.
The CRL was attributed to pre-approval manufacturing deficiencies along with submission of additional data ahead of the NDA that required more review time. Koffler hypothesizes that this could have been the human drug-drug interaction data on the ZS-9 molecule, which Relypsa submitted post-approval on Veltassa, while the manufacturing issue is more difficult to predict.
"We previously indicated that this outcome represents the best possible scenario for Relypsa as it gives it more time to gain traction in the market as first-mover and increases the likelihood of takeout interest in the name," Koffler said.
"That said, we still view the Veltassa launch trajectory as quite slow and expect the stock to remain relatively range-bound until growth becomes more tangible. Today we expect a strong rebound to the stock towards our $31 takeout valuation and will re-evaluate our rating and PT after speaking with mgmt."