Akebia Therapeutics (na fusie met Keryx)

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Re: Akebia Therapeutics (na fusie met Keryx)

Bericht door believer » 12 mar 2019 12:04

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Re: Akebia Therapeutics (na fusie met Keryx)

Bericht door Jojo » 12 mar 2019 12:13

Press Release










Akebia Therapeutics Announces Positive Top-Line Results from Two Pivotal Phase 3 Studies of Vadadustat in Japanese Patients with Anemia Due to Chronic Kidney Disease






PDF VersionPDF Version

– Each Study Met Its Primary Endpoint –

– Regulatory Submission in Japan Expected in 2019 –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 12, 2019-- AkebiaTherapeutics, Inc. (Nasdaq:AKBA) today announced positive top-lineresults from two phase 3 active-controlled pivotal studies evaluatingvadadustat, an investigational oral hypoxia-inducible factor prolylhydroxylase inhibitor (HIF-PHI), in Japanese subjects with anemia due tochronic kidney disease (CKD). These studies were conducted by Akebia’sdevelopment and commercialization collaboration partner in Japan, Mitsubishi Tanabe Pharma Corporation (MTPC). Each study, one innon-dialysis dependent subjects and one in hemodialysis-dependentsubjects, met its primary endpoint. In addition, results from two phase3 single-arm studies conducted by MTPC in peritoneal dialysis subjectsand hemodialysis subjects further support vadadustat’s potential inthese indications. MTPC expects to submit a Japanese New DrugApplication in 2019.

“Collectively, these data provide further confirmation of vadadustat’spotential to meaningfully transform the treatment paradigm for patientswith anemia due to CKD,” said John P. Butler, President and ChiefExecutive Officer of Akebia. “These results add to our datasetdemonstrating the potential for vadadustat to effectively managehemoglobin levels in both dialysis-dependent and non-dialysis dependentpatients, including those who convert from erythropoiesis stimulatingagents.”

Top-Line Results from the Pivotal Phase 3 Study in Non-DialysisDependent CKD Subjects (J01 Study)
The phase 3 randomized, open-label, active-controlled correction andconversion study assessed the efficacy and safety of vadadustatcompared to darbepoetin alfa, an erythropoiesis stimulating agent(ESA), in 304 Japanese non-dialysis dependent subjects with anemia dueto CKD, with a treatment duration of 52 weeks. Data from the plannedanalysis at 24 weeks are provided. The study met its primary endpoint,with the mean hemoglobin (Hb) level at week 20 and week 24 at 11.66g/dL (95% CI 11.49, 11.84 g/dL) for vadadustat-treated subjectscompared to 11.93 g/dL (95% CI 11.76, 12.10 g/dL) for darbepoetinalfa-treated subjects. The difference in mean Hb was -0.26 g/dL (95%CI -0.50, -0.02 g/dL), achieving the pre-specified non-inferioritycriterion of -0.75 g/dL. The incidence of adverse events (AEs) was72.2% in the vadadustat-treated group compared to 73.2% in thedarbepoetin alfa-treated group. The most common AEs reported invadadustat-treated subjects were nasopharyngitis (14.6%), diarrhea(10.6%), constipation (5.3%), and contusion (5.3%). The incidence ofserious adverse events (SAEs) was 13.9% in the vadadustat-treatedgroup compared to 14.4% in the darbepoetin alfa-treated group; no SAEwas considered related to study drug. No deaths were reported in thevadadustat-treated group, and one fatal myocardial infarction wasreported in the darbepoetin alfa-treated group, which was assessed asnot related to study drug.

Top-Line Results from the Pivotal Phase 3 Study in Dialysis-DependentCKD Subjects (J03 Study)
The phase 3 randomized, double-blind, active-controlled conversionstudy assessed the efficacy and safety of vadadustat compared todarbepoetin alfa in 323 Japanese hemodialysis subjects with anemia dueto CKD who had been receiving ESA therapy prior to study screening,with a treatment duration of 52 weeks. Group level data at 24 weeksfrom this ongoing double-blind study are provided. The study met itsprimary endpoint, with the mean Hb level at week 20 and week 24 at10.61 g/dL (95% CI 10.45, 10.76 g/dL) for vadadustat-treated subjectscompared to 10.65 g/dL (95% CI 10.50, 10.80 g/dL) for darbepoetinalfa-treated subjects. The difference in mean Hb was -0.05 g/dL (95%CI -0.26, 0.17 g/dL), achieving the pre-specified non-inferioritycriterion of -0.75 g/dL. The incidence of AEs was 89.5% in thevadadustat-treated group compared to 88.2% in the darbepoetinalfa-treated group. The most common AEs reported in vadadustat-treatedsubjects were nasopharyngitis (19.8%), diarrhea (10.5%), and shuntstenosis (8.0%). The incidence of SAEs was 13.0% in thevadadustat-treated group compared to 10.6% in the darbepoetinalfa-treated group; no SAE was considered related to study drug.

Top-Line Results from Two Phase 3, Single-Arm Studies inDialysis-Dependent CKD Subjects (J02 Study and J04 Study)
The phase 3 open-label, single-arm J02 study assessed the efficacy andsafety of vadadustat in 42 Japanese peritoneal dialysis subjects withanemia due to CKD, with a treatment duration of 24 weeks. The mean Hblevel at week 20 and week 24 was 11.35 g/dL (95% CI 10.99, 11.70 g/dL)for vadadustat-treated subjects. Thirty-eight subjects (90.5%)experienced an AE and twelve (28.6%) experienced an SAE. One SAE offatal myocardial ischemia was assessed as possibly related tovadadustat by the investigator.
The phase 3 open-label, single-arm J04 correction study evaluated thesafety and efficacy of vadadustat, with a treatment duration of 24weeks, in 24 Japanese hemodialysis subjects with anemia due to CKD whohad not been receiving ESA therapy prior to study screening or whounderwent ESA washout during screening. The mean Hb level at week 20and week 24 was 10.75 g/dL (95% CI 10.35, 11.14 g/dL) forvadadustat-treated subjects. Twenty-three subjects (95.8%) experiencedan AE, and seven (29.2%) experienced an SAE. No SAE was assessed asrelated to study drug, and no deaths were reported.

Akebia will discuss these findings on its previouslyannounced fourth quarter and full-year 2018 investor update call on Monday, March 18, 2019 at 4:30 p.m. Eastern Time. Additional data fromthe studies are expected be presented by MTPC at an upcoming medicalmeeting.

In Japan, an estimated 13 million people are afflicted with advancedstages of CKD. Anemia is common in patients with CKD and its prevalenceincreases as CKD progresses. Injectable ESAs are currently the standardof care. Vadadustat, if approved for marketing, would provide patientswith a once-daily oral treatment option and has the potential to set anew standard of care for the treatment of anemia due to CKD.

About Vadadustat

Vadadustat is an oral hypoxia-inducible factor (HIF) prolyl hydroxylaseinhibitor currently in global phase 3 development for the treatment ofanemia due to chronic kidney disease. Vadadustat’s proposed mechanism ofaction is designed to mimic the physiologic effect of altitude on oxygenavailability. At higher altitudes, the body responds to lower oxygenavailability with increased production of HIF, which coordinates theinterdependent processes of iron mobilization and erythropoietinproduction to increase red blood cell production and, ultimately,improve oxygen delivery. Vadadustat is an investigational therapy and isnot approved by the U.S. Food and Drug Administration or any otherregulatory authority.

About Akebia Therapeutics

Akebia Therapeutics, Inc. is a fully integrated biopharmaceuticalcompany focused on the development and commercialization of therapeuticsfor patients with kidney disease. The company was founded in 2007 and isheadquartered in Cambridge, Massachusetts. For more information, pleasevisit our website at www.akebia.com,which does not form a part of this release.

Forward-Looking Statements

This document contains forward-looking statements within the meaning ofthe federal securities laws. Such statements are based upon currentplans, estimates and expectations that are subject to various risks anduncertainties. The inclusion of forward-looking statements should not beregarded as a representation that such plans, estimates and expectationswill be achieved. Words such as “anticipate,” “create,” “expect,”“project,” “intend,” “believe,” “may,” “will,” “should,” “plan,”“could,” “target,” “contemplate,” “estimate,” “position,” “predict,”“potential,” “opportunity,” “working to,” “look forward” and words andterms of similar substance used in connection with any discussion offuture plans, actions or events identify forward-looking statements. Allstatements, other than historical facts, including regarding plans forregulatory submissions, the potential to set a new standard of care, andmarket and growth opportunity and potential, are forward-lookingstatements. Important factors that could cause actual results to differmaterially from Akebia’s plans, estimates or expectations could include,but are not limited to: whether the data from the phase 3 clinicaltrials of vadadustat in Japanese subjects will warrant a Japanese NewDrug Application (JNDA) submission on the timeline expected, or at all,and whether any such JNDA will be approved; the timing and content ofinteractions with and decisions made by regulatory authorities; andsuccess of others in developing competing products. Other risks anduncertainties include those identified under the heading “Risk Factors” in Akebia’s most recently filed Quarterly Report on Form 10-Q, and otherfilings that Akebia may make with the U.S. Securities and ExchangeCommission in the future. Akebia does not undertake, and specificallydisclaims, any obligation to update any forward-looking statementscontained in this press release.




View source version on businesswire.com: https://www.businesswire.com/news/home/ ... 005287/en/

Source: Akebia Therapeutics, Inc.

Akebia Therapeutics Contact:
Argot Partners
MelissaForst / Maghan Meyers
(212) 600-1902
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2019 : het jaar van .........

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Re: Akebia Therapeutics (na fusie met Keryx)

Bericht door believer » 12 mar 2019 12:20

Nu voorbeurs 45% en zeer veel aandelen zitten bij de grote zoals Clarman. Shortsqeeuze in de maak of overname?
Laatste weken waren er al heel weinig verkopers

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Re: Akebia Therapeutics (na fusie met Keryx)

Bericht door sanderus » 12 mar 2019 12:56

Zeer mooi nieuws. Resultaten van 2 Japanse studies (Correction and conversion) in een open label head to head studie met darbepoetin alfa (Aranesp) waarbij het primaire eindpunt werd bereikt.

Zolas je in onderstaande kan zien zijn er nog verschillende studies lopende in de VS + EU met uitlezingen in 2020
U kunt zich hier registreren om de bijlage te zien.
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Re: Akebia Therapeutics (na fusie met Keryx)

Bericht door Karl » 12 mar 2019 14:49

believer schreef:Dik feest en shortsqeeuze

http://ir.akebia.com/news-releases/news ... esults-two
Dik feest valt nog mee of verwachten jullie in de loop van de dag al reacties van analisten die adviezen en koersdoelen gaan wijzigen?

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Re: Akebia Therapeutics (na fusie met Keryx)

Bericht door believer » 12 mar 2019 15:07

Karl schreef:
believer schreef:Dik feest en shortsqeeuze

http://ir.akebia.com/news-releases/news ... esults-two
Dik feest valt nog mee of verwachten jullie in de loop van de dag al reacties van analisten die adviezen en koersdoelen gaan wijzigen?
Eerste is er al 17$!

https://www.marketbeat.com/stocks/NASDA ... ce-target/

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Re: Akebia Therapeutics (na fusie met Keryx)

Bericht door Karl » 12 mar 2019 16:18

Op $8 heb ik een order geplaatst, dan kan ik het feestje meevieren :? Vanaf de top al bijna 15 procent kwijtgespeeld.


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Re: Akebia Therapeutics (na fusie met Keryx)

Bericht door believer » 16 mar 2019 13:00

Nog een kleine 1,5miljoen verhandeld in de eindveiling :clap:

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Re: Akebia Therapeutics (na fusie met Keryx)

Bericht door sanderus » 18 mar 2019 21:17


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