Relypsa inc (rlyp) headed for soaring growth via veltassa success

Relypsa Inc. Electricity generation ( NASDAQ:RLYP), a highly attractive stock since two months, continues to see growth as the company’s highly successful hyperkalemia drug,Veltassa, yields boosting sales growth. Gas in oil lawn mower Only yesterday, the company released prescriptions data of its top-selling drug, with a strong increase in both new patient and outpatient prescriptions covered.

This data was able to reignite investor interest in the stock. Ortega y gasset obras completas Relypsa is up nearly 3.7%, trading at a high of $21 in after-hours trading as of 7:36 AM EDT. Static electricity in water The surge is expected to continue when trading resumes today.

The boost adds to the stock’s northward journey continuing since May 27, when the company’s competing hyperkalemia treatment, ZS-9, by AstraZeneca received a rejection from the US Food and Drug Administration, delaying the approval based on a manufacturing snag. Electricity and circuits class 6 cbse AstraZeneca’s failure in the hyperkalemia space revived analysts’ confidence in Relypsa’s Veltassa, which is now expected to remain the market leader for another year, and is safe from any major competitive threat. Mp electricity bill payment online jabalpur Prior to ZS-9’s rejection, Relypsalost a hefty 41.4% since the beginning of the year in wake of a potential blow from AstraZeneca’s hyperkalemia drug. Gas 47 cents The current upward trend in Relypsa stock is expected to offset much of the loss.

Relypsa’s Veltassa won the green signal from FDA in October 2015 as the first-ever effective treatment approved for hyperkalemia in over 50 years. Electricity and circuits physics Hyperkalemia is a condition marked by high levels of potassium in the bloodstream, which usually translates into abnormal heart rhythms and can be potentially deadly. Gas vs electric water heater savings It is most commonly found in patients suffering from underlying conditions of chronic kidney disease (CKD) or heart failure (HF). Gas vs electric oven efficiency Some common treatments used for CKD or HF patients like ACE inhibitors or ARBs have been known to induce hyperkalemia as a common side-effect.

When Veltassa won FDA nod last year, it brought good news for a large patient population suffering from this potentially fatal disease; as per current figures, nearly three people inside the US alone suffer from the underlying conditions which can lead to hyperkalemia. Gas in dogs symptoms The hyperkalemia market is thought be as large as $6 billion.

Veltassa emerged as the one and only effective treatment option to target this large market and the best alternative to conventional treatment of Kayexalate, which had been associated with some serious, adverse events such as intestinal cell death and gastrointestinal bleeding. Electricity bill saudi electricity company However, Veltassa itself came with FDA’s strictest black-box warning which suggested the drug be used at least six hours apart from other oral drugs. Static electricity zap The drug’s label also stated: “it’s not appropriate for rapid correction of severe hyperkalemia because lowering of serum potassium may take hours to days.”

Because of these attached risks, the doctors were wary of recommending this drug to all hyperkalemia patients as it would involve “changing the habit of a lifetime,” as explained by John Orwin, Chief Executive Officer at Relypsa. Electricity per kwh The drug’s uptake was thus far below expectations and disappointed many analysts and investors, who lost confidence in Relypsa stock as a result; this translated into a fall of more than 48% for the company’s shares in the first five months of this year.

A much needed boost for Relypsa came at the end of May, when the most eagerly awaited FDA approval for AstraZeneca’s hyperkalemia alternative, ZS-9, met a surprising rejection. Gas city indiana newspaper The regulator issued a complete response letter (CRL) to AstraZenenca on May 27 highlighting some major manufacturing concerns that needed to be catered to. Gas 0095 The company has, however, not been asked to carry out any additional trials, which still reflects some hope in ZS-9’s effectiveness.

The recent delay in FDA approval for ZS-9 means the launch won’t happen before 2017; once AstraZeneca resubmits the drug for approval after meeting all the requirements, it would still take atleast six months for the FDA review. Gas finder rochester ny This gives Relypsa enough time to establish its drug as the top and undisputed leader in the hyperkalemia treatments space and reap full benefit from its pioneering advantage. Electricity questions and answers physics Relypsa’s Recent Wins

Relypsa is playing smart by trying to get rid of FDA’s black box warning on its Veltassa to eliminate the potential competitive threat from ZS-9. Gas and water company ZS-9, on track to be approved by next year, is not expected to carry FDA’s boxed warning which would make it a better treatment alternative over Veltassa.

If Relypsa succeeds in getting the warning removed soon, it is sure to gain an unsurpassed dominance in the hyperkalemia field. Electricity cost per kwh south africa The biopharmaceutical company has already submitted a supplemental New Drug Application to FDA asking for label changes on the drug supported by positive results from phase 1 drug-drug interaction clinical trials.

Wedbush analyst Liana Moussatos stated in a recent research report that the firm expects Relypsa to succeed in getting the boxed warning on Veltassa removed by the end of this year. Electricity for dummies amazon “Relypsa recently announced submission of a sNDA to the FDA with data from the Phase 1 drug-drug interaction (DDI) study that showed no reduction in activity when dosing of Veltassa and certain drugs commonly prescribed for CKD and heart failure were separated by three hours and no clinically meaningful interaction for many drugs when co-administered with Veltassa. Gas youtube Given these results, we believe Relypsa is likely to be successful in requesting the FDA remove the black box warning, reduce the drugdrug separation time from 6 hours to 3 hours and having the DDI results included in a standard section of the package insert.”

Adding to the recent wins, Relypsa released pivotal data from Phase 3 OPAL-HK study toward the last week of June, which established the potassium-lowering effect of Veltassa’s via its capability of lowering blood pressure as well as aldosterone levels. P gasol stats This feature is bound to give a strong differentiating edge over its main rival, Z-S9, which has been known for causing transient increases in serum sodium and blood pressure. 76 gas station credit card login Scripts Data Trend

A label change for Veltassa combined with ZS-9’s approval delay is expected to translate into a major boost for Veltassa’s sales, moving forward. Gas out game directions The recent data on the drug’s scripts clearly suggests that Veltassa is already headed for strong growth.

As per the scripts data revealed for the month of June yesterday, the total of new patients who began Veltassa’s use with a free starter supply stood at 1,531, showing an increase of 10.5% from May and a hefty 26%, in comparison to April. Gas prices going up june 2016 Outpatient prescriptions covered and filled registered an even higher growth, coming in at 1,723, signifying an increase of 40% from May, and a striking 86% from April. 1 unit electricity cost in india Hospital/institution units sold in June came out to be 392, with a 41% increase on a quarter-over-quarter (QoQ) basis. Wikipedia electricity generation Attractive Acquisition Target

With this growth trend, Veltassa is soon expected to become a top blockbuster drug for the company; the drug has a potential to reap $1.4 billion in annual sales, as per Street’s estimates. Gas jobs crna The striking growth prospects expected for Veltassa makes Relypsa an attractive acquisition target for large drugmakers looking for high growth assets. 5 gases in the atmosphere Pfizer, Merck, Biogen, and AstraZeneca have already been cited as possible acquirers for the company. Electricity diagram flow In addition, Sanofi SA might also eye Relypsa for a buyout since it is already partnering with Relypsa on marketing of Veltassa inside the US.

AstraZeneca went ahead to buy ZS Pharma for its hyperkalemia treatment target paying a hefty premium of 42%. Electricity fallout 4 This, combined with recent growth trend in Veltassa’s sales, clearly suggests that Relypsa is capable of attracting a takeover bid with a much higher premium.