Keryx Biopharma - KERX

:mmmm: se nn ricordo male il duo :cool:aveva posto tp prudenziale a 5$ ... ma rivisto in upgrade tra i 10$ -15$ :cool::cool::cool:

sbaglio acqua+? :D


Gli analisti VERI ,,,, arrivano adesso :lol::lol::lol:



Brean Murray Ups Keryx (KERX) Target to $5 Following Zerenex OLE Trial Results
Sep 23, 2009 12:57PM
An analyst at Brean Murray raised his price target on shares of Keryx Pharma (Nasdaq: KERX) from $3 to $5 earlier. The firm maintains a Buy rating.

The increased price target follows news this morning that the company reported results from an Open Label Extension trial of Zerenex. The analyst believes that Keryx can now "focus on Zerenex's numerous benefits such as reduce pill burden compared to Renagel/Renvela, a potential reduction in iron requirements, no hypercalcemia or fear of lanthanum accumulation, and a modest cost compared to Renagel/Renvela..." Brean Murray notes that phosphate binders had sales of more than $600 million in the US last year, and the market is growing at 25% on a year-over-year basis.

The firm expects a Phase 3 trial to start by the end of this year.

The analyst's new price target is based on the summation of Keryx's development pipeline: an estimated value of $140 million for Zerenex and $100 million for Perifosine, with cash of about $23 million.
 
Dickkkk ,,, ti ricordi ,,,, a marzo su FOL ,,,, Kerx stava a 0,11 :eek::eek::eek:

quei PIRLUN che ci davano dei PAZZI VISIONARI ,,,, quando dicevamo 5$ :D:D:D:D


vedi delle analogie con l'attualità di qlc titolo ??????? :fiu::fiu::fiu:
 


Investment Highlights

Overview

KERX engages in the acquisition, development and commercialization of drug therapies for the treatment of renal disease and cancer. The Company’s novel, oral, anti-cancer agent called KRX-0401 (perifosine) is developed to inhibit cell growth and cell transformation. KRX-0401 has cleared phase I clinical trials for safety and efficacy. KRX-0401 is currently in phase II clinical trials to determine efficacy for multiple tumor types, and phase III for the efficacy to treat multiple myeloma. The Company seeks strategic relationships to develop drug candidates, including evaluating compounds for acquisition or licensing.

Market Size

The United States’ market for end-stage renal disease dialysis is estimated to reach more than $2 billion in 2010, and reach more than $11 billion worldwide. According to the Cancer Market Outlook report published by Business Insights, the market for cancer therapeutic drugs is expected to reach $40.9 billion by 2012.

Company Drug Candidates

KRX-0401 (perifosine)

KRX-0401 (perifosine) is the Company’s lead oral anti-cancer agent developed to modulate important signal transduction pathways, including the JNK and MAPK pathways. JNK and MAPK are identified as the pathways associated with the growth, differentiation, death and survival of human cells. KRX-0401 modulates the Akt pathway, which is believed to be the pathway for the development of most cancers. The Company has evidence that these pathways are activated in tumors, which have historically resisted traditional anticancer therapies. The Company’s challenge is to inhibit this pathway without excessive toxicity to the patient.

Tested in more than 1,800 patients, the Company has demonstrated a distinctly different safety profile from most cytotoxic agents. Typical cytotoxic agents usually cause flu-like symptoms, decreased platelet count and and/or hair loss; but in contrast, KRX-0401 does not cause these symptoms. KRX-0401 causes different symptoms, including nausea, vomiting, diarrhea and fatigue; however, these symptoms are easily managed particularly at lower dosages of 50 mg and 100 mg. At this daily dosage level, tumor regression and manageable symptoms were indicated.

Zerenex (ferric citrate)

Zerenex (ferric citrate) is an iron-based compound developed to bind to phosphate, forming non-absorbable complexes. In phase II clinical trials, Zerenex was proved safe and efficacious to treat elevated phosphate levels in patients with end-stage renal failure. In the United States, phase III clinical trials of the drug are nearly complete. In addition to the United States market, Zerenex is in phase II clinical trial for the introduction of the drug therapy in the Japanese market, and has undergone development in conjunction with partners, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd.

Recent News

On September 16, the Company said it had received notification by the Food and Drug Administration that KRX-0401 (perifosine) was given Orphan Drug Status—a status given to drugs which have promise to treat rare or untreated conditions or disease. An FDA Orphan Drug Status offers incentives for further development, including a seven-year exclusivity protection period following FDA approval, clinical trial help from the FDA, reduced FDA fees and tax credits.
 
Updated Single Agent Phase 2 Data of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Renal Cell Carcinoma Reported at the Eighth International Kidney Cancer Symposium - Yahoo! Finance

Updated Single Agent Phase 2 Data of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Renal Cell Carcinoma Reported at the Eighth International Kidney Cancer Symposium

KRX-0401 (Perifosine) Continues to Demonstrate Impressive Efficacy, Safety and Tolerability in Metastatic Renal Cell Carcinoma Patients who Progressed after Failing Treatment with both a VEGF Receptor Inhibitor and an mTOR Inhibitor

NEW YORK, Sept. 29 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX - News) today announced updated clinical results from a Phase 2 study of KRX-0401 (perifosine), the Company's PI3K/Akt pathway inhibitor for cancer, as a single-agent treatment for advanced metastatic renal cell carcinoma (RCC). Dr. Thomas E. Hutson, Director of the Genitourinary Oncology Program at Baylor-Sammons Cancer Center in Dallas, Texas, presented the data on Saturday, September 26th, in an oral presentation featured at the Eighth International Kidney Cancer Symposium held in Chicago.

Dr. Hutson's presentation, entitled "Phase 2 study of perifosine in patients with metastatic renal cell carcinoma progressing after prior therapy with both a VEGF Receptor Inhibitor and an mTOR inhibitor," included results from a subgroup of patients who failed both a VEGF receptor inhibitor (sunitinib or sorafenib) and an mTOR inhibitor (temsirolimus or everolimus). Evaluable patients (n=16) were defined as those who had greater than 7 days of treatment (2 additional patients withdrew consent within 7 days). Patients received 100 mg of perifosine daily until progression or unacceptable toxicity. The primary endpoint of this study was clinical benefit, defined as response rate (CR / PR by RECIST) or percent of patients progression-free for at least 3 months. Median progression-free survival (PFS) and overall survival were also analyzed for efficacy. Safety was a secondary endpoint. Perifosine was well-tolerated with the most common adverse events being gastrointestinal discomfort and fatigue. Best response to single agent perifosine was as follows:

PR SD > 12 wks PD < 12 wks Overall
N N (%) N (%) N (%) Median PFS Survival
---- ------ ----------- ----------- ------------------- -------------
16 1 (6%) 7 (44%) 8 (50%) 16 wks [95% CI
(11.7, 28)] Not Reached
---- ------ ----------- ----------- ------------------- (14/16 alive)
Median PFS for patients SD or > 33 wks [95% CI at 22+ months
(19, NR)]
--------------------------------------- ------------------- -------------

PR: Partial response; SD: Stable disease; PD: Progressive disease



This multi-center Phase 2 study was led by both Dr. Hutson and Dr. Nicholas Vogelzang, Chair and Medical Director of Developmental Therapeutics, Comprehensive Cancer Centers of Nevada / US Oncology Research. Drs. Hutson and Vogelzang also serve as co-chairs of the Genitourinary Committee for US Oncology Research. Data from this study was first presented by Dr. Vogelzang at the American Society of Clinical Oncology (ASCO) annual meeting in May 2009.

Commenting on the data, Dr. Hutson stated, "Perifosine continues to demonstrate impressive single agent activity and safety in an advanced group of RCC patients, with 50% of patients progression-free for a median of 8 months. Given the convenient oral schedule, with a manageable safety profile and demonstrated efficacy, future studies with perifosine in the 2nd or 3rd line setting (single agent or in combination with an mTOR inhibitor) should be considered."

Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, remarked, "We continue to be encouraged by the single agent activity of perifosine in the treatment of advanced renal cell carcinoma. While preliminary, perifosine's response and PFS data presented appear equivalent to that of other agents for advanced RCC, which were approved in a less heavily pre-treated patient population. We look forward to evaluating future perifosine trial designs with Dr. Hutson, Dr. Vogelzang and other RCC experts."

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (Nasdaq: AEZS - News; TSX: AEZ - News) in the United States, Canada and Mexico.

About Renal Cell Carcinoma (RCC)

Of all kidney tumors, 85% are classified as renal cell carcinoma (RCC), and of all patients with RCC, 25% present with advanced disease. Advanced RCC is resistant to such standard treatments as radiation therapy and chemotherapy, and the initial treatment for most patients is surgical removal of the kidney. If the cancer is confined to the kidney, the five-year survival rate is 60 to 70 percent; but the survival rate is considerably lower after the cancer has metastasized to other parts of the body. Even with the recent approval of several biological therapies for the treatment of advanced metastatic RCC (VEGF inhibitors, sunitinib and sorafenib, and mTOR inhibitors, everolimus and temsirolimus), the National Cancer Institute reports a rising incidence of RCC with incidence and mortality rates more than twice as high in men as in women. In 2009, an estimated 49,000 new cases of RCC and 11,000 deaths attributable to RCC are expected in the United States.
 
Keryx Pharma Could Turn into a Real Winner Down the Road -- Seeking Alpha

Keryx Pharma Could Turn into a Real Winner Down the Road
September 30, 2009

n an early Tuesday press release, Keryx Pharmaceuticals (KERX) announced positive information regarding the continued "impressive" efficacy of its treatment for Advanced Metastatic Renal Cell Carcinoma, Perifosine. This news followed the recent announcement of positive Phase II trials for Zerenex, the company's treatment for developing kidney disease.

While I do believe that KERX, based on the Phase II results of both of the above mentioned drugs, is a good pick for the long term, we're still only talking about Phase II trial results and both drug candidates are still a long ways off before they have a chance to make it to market. That is why, in my opinion, the stock could see a slide back down to the $2 level - or below - once again.

A recent stock offering was announced for $2.50/share - in a move that the company says will raise $20 million towards funding Phase III trials - but it's common in the biotech sector to see a stock price drop below an offering price in the weeks following the offering.

I still like KERX as an accumulation play, but I would temper accumulation at these prices and see if it drops at all.

That being said, KERX could turn into a real winner later on down the road if Perifosine and Zerenex continue to impress. It also may be worth looking out for a partnership deal - I'm not so sure that the recently raised $20 million will be enough to carry both drugs through Phase III trials. With positive Phase II already in the basket, a larger pharma may wish to take a chance on one or both of the drugs and offer Keryx an up front payment to do so.

Accumulate KERX for the long term, but don't be surprised if it dips to the $2 level again.

Disclosure: Sold position for just over $3.
 
Keryx Biopharmaceuticals to Present at the Oppenheimer 20th Annual Healthcare Conference
Presentation Scheduled for Wednesday, November 4th at 4:30PM ET

"solita" presenza di rappresentanza? ..o occasione per qualche comunicato ?

QUI

e

WEBCAST



altra presenza per settimana prossima

11/10/09 3:40 p.m. ET
Keryx Biopharmaceuticals, Inc. at Merriman Curhan Ford Investor Summit

e

WEBCAST
 
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