KERX Keryx Biopharmaceuticals Inc
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Ik ben ook ingestapt Genkie. gekocht op 7.09
Gaat weer lekker hier, 11,53$ . Het begint weer te kriebelen om te verkopen, ze zijn nu 56 keer meer waard als toen ik ze kocht.
Ik verwacht ze volgend jaar rond de 25 als zerenex goedgekeurd is door de fda en de verkoop start.
deze week weer een partij bijgekocht. Ik hoop dat ze hetzelfde trackrecord volgen als cldx (wat een topper dit jaar) +500%
Had cldx ook en heb ze verkocht aan 12 dollar omdat ik ze toen al te duur vond. Had ze gekocht aan 4,5 dollar. Daarom dat ik t nu ook zo moeilijk vind om te verkopen. Heb me gisteren nog wat clsn bijgekocht en vandaag nog wat zlcs.
CTIC is ook een potentiële kanshebber. Bedrijf heeft nagenoeg geen schulden. Toch uitzonderlijk voor biotech
Keryx Biopharma (NASDAQ: KERX) announced that the U.S. Food and Drug Administration (FDA) approved Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
"We are thrilled with the FDA's decision to approve Ferric Citrate, and look forward to bringing it to market in the U.S. within the next 12 weeks," said Ron Bentsur, Chief Executive Officer of Keryx. "We are committed to bringing innovative therapies to the market for patients with kidney disease and are excited to be offering this important treatment option to dialysis patients."
The U.S. approval of Ferric Citrate was based on data from its Phase 3 registration program. In the Phase 3 clinical trials, Ferric Citrate effectively reduced serum phosphorus levels to well within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL. In addition to the effects on serum phosphorus levels, Ferric Citrate's pharmacodynamic properties resulted in increased ferritin and transferrin saturation (TSAT); whereas these parameters remained relatively constant in patients treated with active control (Renvela® and/or Phoslo®). The most common adverse events for Ferric Citrate treated patients were gastrointestinal-related, including diarrhea, nausea, vomiting and constipation.
"I believe that Ferric Citrate offers clear benefits to patients and represents a new way for physicians to manage hyperphosphatemia," said Julia Lewis, MD, lead investigator, nephrologist and Professor of Medicine at Vanderbilt University Medical Center. "Given Ferric Citrate's pharmacodynamic properties that lead to increases in iron stores, physicians should assess and monitor iron parameters and may need to reduce the dose of or discontinue IV iron therapy."
Recently, the Company was informed by the FDA that approval of the brand name Zerenex had been rescinded. Keryx believes the Company will have an approved brand name on or prior to launch, although a brand name is not a pre-requisite for the launch of an FDA-approved drug.
Vorige week aangekocht aan € 6,91
UPDATE: Keryx Biopharma (KERX) Could Be Worth $1-$1.2 Billion In M&A Deal Updated - July 3, 2017 9:37 AM EDT) (updated to add add comments on guidance raise) Raymond James maintains Outperform on Keryx Biopharma (NASDAQ: KERX) price target of $9.00. Analyst Reni Benjamin said the company could fetch over a $1 billion in a deal which may occur before the company releases Pdufa data in November according to an email reviewed by Street Insider. That would be a premium of nearly 20% over the current market capitalization of $805 million. Benjamin comments that should strong prescription trends persist "we believe they will likely need to raise guidance." Benjamin speculated that possible suitors could be either DaVita (NYSE: DVA), Sanofi (NYSE: SNY) or Vifor Frensenius, the JV operation between Vifor Pharma and Fresenius Medical Care (NYSE: FMS). He says that as biotech firms reach commercialization there has been chatter for the potential for M&A. For an analyst ratings summary and ratings history on Keryx Biopharmaceuticals click here. For more ratings news on Keryx Biopharmaceuticals click here.
Piddybull schreef op 4 jul 2017 om 00:02:
Vorige week aangekocht aan € 6,91
UPDATE: Keryx Biopharma (KERX) Could Be Worth $1-$1.2 Billion In M&A Deal Updated - July 3, 2017 9:37 AM EDT) (updated to add add comments on guidance raise) Raymond James maintains Outperform on Keryx Biopharma (NASDAQ: KERX) price target of $9.00. Analyst Reni Benjamin said the company could fetch over a $1 billion in a deal which may occur before the company releases Pdufa data in November according to an email reviewed by Street Insider. That would be a premium of nearly 20% over the current market capitalization of $805 million. Benjamin comments that should strong prescription trends persist "we believe they will likely need to raise guidance
." Benjamin speculated that possible suitors could be either DaVita (NYSE: DVA), Sanofi (NYSE: SNY) or Vifor Frensenius, the JV operation between Vifor Pharma and Fresenius Medical Care (NYSE: FMS). He says that as biotech firms reach commercialization there has been chatter for the potential for M&A. For an analyst ratings summary and ratings history on Keryx Biopharmaceuticals click here. For more ratings news on Keryx Biopharmaceuticals click here.
Zeker een interessant aandeel, staan op de radar. Een premie van 20% is mager, dacht eerder aan $14/15, koersen van 2014/2015. Het medicijn trekt aan nadat het weer op de markt is gekomen, geen problemen meer met de makers. Benieuwd naar de aanstaande cijfers.
Gaat vandaag goed, een nieuwe 52wks high op een goed volume. RT 8,05.
Ik zit er nu erg behoorlijk in.
Sinds vorige week verhoogd tot 45 % van mijn huidige portefeuille.
Vrijdag heeft het ook op vrij hoog volume alle kanten uitgedraaid om op hetzelfde niveau te eindigen.
Namelijk : $ 7,86
Als ik goed geïnformeerd ben zouden de Q2 cijfers begin augustus moeten vrijgegeven worden.
Daarna is de belangrijkste datum 06 november voor de PDUFA
Aantal scripts vorige week : IMS 999
Why Keryx Biopharmaceuticals Stock Soared 11.6% Higher in June !
Sales are finding their footing at this biotech, and optimism is increasing ahead of an important FDA decision later this year.
Todd Campbell (TMFEBCapital)
Jul 8, 2017 at 6:31AM
What happened ?
After the biotech issued an update on its first-quarter progress in May, investors continued buying Keryx Pharmaceuticals (NASDAQ:KERX) shares in June, sending them 11.6% higher last month, according to S&P Global Market Intelligence. So what Keryx Biopharmaceuticals was once a high-flying biotech star, but its reliance on one commercial drug caused shares to crash when sales were slow to grow and production difficulties crimped prescriptions in 2016.
Now, it appears Keryx Biopharmaceuticals is regaining some of its luster. The company's lone drug is Auryxia, a treatment that removes excess phosphorous from chronic kidney disease patients on dialysis. Phosphorous can build up in these patients, stripping away calcium from bones, weakening them, and potentially creating calcium deposits that can cause heart disease.
Auryxia launched to nine-figure sales projections, but net product sales totaled only $27.2 million in 2016. This year, however, Auryxia may begin to get closer to analysts' rosy outlook. In Q1, net product sales in the U.S. were $10.5 million, and management thinks that full-year 2017 net product sales will come in between $56 million and $60 million.
Sales could grow much bigger than that in 2018, however, if the FDA approves Auryxia's use in stage 3 to 5 chronic kidney disease patients not on dialysis. In phase 3 trials, Auryxia helped treat anemia in these patients, and the FDA has set a target action PDUFA date of Nov. 6 to decide on whether to expand the drug's label.
If it does, then it will significantly increase Auryxia's addressable patient population !
An estimated 1.6 million Americans with stage 3 to 5 non-dialysis dependent chronic kidney disease have iron deficiency anemia. Now what Despite revenue gaining momentum, Keryx Biopharmaceuticals continues to lose money. In Q1, spending led to a loss of $23 million and cash burn of $21 million. As a result, the company's balance of cash and cash equivalents has fallen to $90.9 million.
There isn't a cash crunch yet, but Keryx could end up tapping equity markets with a stock offering later this year if sales fall shy of projections or the FDA passes on approving the expanded label. Nevertheless, Keryx Biopharmaceuticals is an intriguing stock for bargain hunters to consider buying.
The company's $850 million market cap isn't too rich of a valuation (assuming the FDA allows expanded use of Auryxia), and an argument can be made that a suitor could come knocking on its door if the FDA gives it a green light in November.
Todd Campbell has no position in any stocks mentioned. His clients may have positions in the companies mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
Bron : www.fool.com/investing/2017/07/ ... -high.aspx
Met dank aan Sanderus
Will patience (finally) pay off?
Keryx Pharmaceuticals' Auryxia won FDA approval in 2014, but so far, the drug has been more of a commercial dud than a stud. Auryxia reduces phosphorous levels in chronic kidney disease patients on dialysis, and while Auryxia's oral dosing offers advantages to existing phosphate binders, it's struggled to gain a toehold in the indication. Auryxia's net product sales were just $27.2 million last year, which is less than 3% of what Sanofi's Renagel and Renvela -- the most common phosphate binders -- hauled in during 2016. Obviously, Auryxia's performance so far has been disappointing, but there's evidence that demand for the drug is picking up, and that sales could accelerate in the coming couple of years. Auryxia's sales were $10.5 million in Q1, and this year, management thinks sales will exceed $56 million. Revenue could climb even higher in 2018 if the FDA decides to expand Auryxia's label in November. In trials, Auryxia boosted iron levels in non-dialysis patients with stage 3 to 5 chronic kidney disease (CKD). There are 1.6 million patients with CKD in these stages who have iron deficiency anemia, and thus, an approval would significantly increase Auryxia's addressable market. Keryx Biopharmaceuticals shares have more than doubled from their lows, but a market cap of less than $900 million may not adequately reflect Auryxia's peak sales potential, if it gets an FDA green light later this year.
Nu Donderdag normaal voorbeurs cijfers op website Keryx
Zeer benieuwd naar koersverloop daaropvolgend.
FDA : 06 November blijft wel belangrijkere trigger !
Nieuw twitteraccount sinds 08 augustus LL.
Nog 76 dagen of slechts 54 handelsdagen voor 06 november
KERYX BIOPHARMACEUTICALS TO WEBCAST ITS PRESENTATIONS AT INVESTOR HEALTHCARE CONFERENCES IN SEPTEMBER 2017
BOSTON, Sept. 05, 2017 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc, (NASDAQ:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with kidney disease, today announced it will webcast corporate presentations at the following investor conferences in September:
A fireside chat at Morgan Stanley’s Global Healthcare Conference in New York City on Tuesday, September 12, 2017 at 12:55 p.m. EDT.
Cantor Fitzgerald’s Global Healthcare Conference in New York City on Monday, September 25, 2017 at 4:45 p.m. EDT.
Ladenburg Thalmann’s 2017 Healthcare Conference in New York City on Tuesday, September 26 at 11:30 a.m. EDT.
Live audio webcasts of the presentations will be accessible from Keryx Biopharmaceuticals’ website at investors.keryx.com within the Investor Relations section under “webcasts and presentations.” An archived version of the webcast will be available for at least 15 days following the conclusion of the live presentations.
Keryx Biopharmaceuticals Announces Changes to its Board of Directors Date(s):
13-Sep-2017 4:11 PM
Mark Enyedy appointed to Keryx's board of directors Current Keryx board member Michael Rogers appointed chairman BOSTON, Sept. 13, 2017 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with kidney disease, today announced the appointment of Mark J. Enyedy as an independent member of the company's board of directors. Mr. Enyedy brings extensive biopharmaceutical leadership experience to the company. John Butler, chairman of the Keryx board of directors and president and chief executive officer of Akebia Therapeutics, Inc., has resigned from Keryx's board. Current Keryx board member Michael Rogers has been appointed as chairman of the board. These changes are effective immediately. "On behalf of the entire board, we look forward to Mike's chairmanship and thank John for his contributions to our company," said Greg Madison, president, chief executive officer and board member of Keryx Biopharmaceuticals. "We are thrilled to have Mark join our board. His experience building leading biopharmaceutical organizations will be invaluable to Keryx as we work to pursue our vision of building a leading multi-product company focused on kidney disease." "Keryx has a unique opportunity, as it prepares for the potential launch of an additional indication for Auryxia, to help more than one million adults with chronic kidney disease in the United States manage two complications of this illness," said Mr. Enyedy. "Auryxia has all of the characteristics of a foundational medicine from which Keryx can build a leading multi-product company focused on improving outcomes for people with kidney disease. I look forward to working with the Keryx team in realizing this vision." "It has been a pleasure to work with the Keryx team," said Mr. Butler. "I am proud of our accomplishments during my time on the board and I look forward to following the company's continued success." Mr. Enyedy has more than 25 years of combined general management, business development, and legal experience in the biotechnology industry across multiple therapeutic areas. He currently serves as president and chief executive officer of ImmunoGen, Inc., a position he has held since 2016. Prior to ImmunoGen, Mr. Enyedy served as executive vice president and head of corporate development for Shire plc leading the company's strategy, merger and acquisitions, and corporate planning functions and providing commercial oversight for the company's pre-Phase 3 portfolio. Previously, Mr. Enyedy served as chief executive officer of Proteostasis Therapeutics, Inc., following 15 years at Genzyme Corporation in diverse roles, and president of the transplant, oncology, and multiple sclerosis divisions. Before joining Genzyme, Mr. Enyedy was an associate with the law firm Palmer & Dodge. He holds a J.D. from Harvard Law School and a B.S. from Northeastern University. Mr. Enyedy also serves on the board of directors of Fate Therapeutics. Pursuant to the company's October 2015 financing transaction with The Baupost Group, LLC., Mr. Enyedy replaces Mr. Butler as Baupost's board appointee.
Zijn er hier nog met Keryx in portefeuille ??
Nog 1 maand !
17 mio short
Nog één nacht !!!
Hopelijk goedkeuring en stevige winst !
We zullen het snel merken.
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