NILE Therapeutics price target

[giasone]

August 16, 2010

Nile Therapeutics Reports 2010 Second Quarter Financial Results


About Nile Therapeutics

-- Nile Therapeutics, Inc. (NASDAQ: NLTX), a company focused on the development of novel therapeutics for heart failure patients today.......

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Update on CD-NP

During June 2010, Nile completed enrolling a placebo-controlled Phase II study of CD-NP in patients with acute decompensated heart failure ("ADHF") in the United States, Germany and Israel. In total, 77 patients were randomized into four doses of CD-NP (1.25, 2.5, 3.75 and 5 ng/kg/min) vs. placebo. The last patient visit occurred at the end of July and final results from the study are expected in the fourth quarter of 2010. Also in the fourth quarter of 2010, Nile plans to submit to the FDA for review and discussion, the clinical protocol for a double-blind, placebo controlled Phase IIb study of CD-NP in ADHF patients.


Nile Therapeutics, Inc.
August 20, 2010
NLTX

Nile Therapeutics, Inc. (NLTX - Analyst Report) is developing CD-NP, a chimeric natriuretic peptide currently in phase II clinical studies for the treatment of acute decompensated heart failure (ADHF).
Prior phase I and phase II data so far has been highly encouraging. With a market capitalization of only $14 million, Nile Therapeutics shares are bafflingly under-valued.

We believe with positive data from the ongoing phase II program in hand the company is worth at least $80 to 100 million. Taking the mid-range at $90 million, and then backing out the $20 million most likely required to fund the phase IIb program, we arrive at a value of $70 million for Nile Therapeutics. This equates to a price of $2.00 per share.

This study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure


Verified by Nile Therapeutics, March 2010
First Received: February 6, 2009 Last Updated: March 5, 2010 History of Changes
Sponsor: Nile Therapeutics
Information provided by: Nile Therapeutics
ClinicalTrials.gov Identifier: NCT00839007
Purpose
The primary objective of the study is to assess the safety and tolerability of IV administration of CD-NP and the dose relationship of CD-NP on improvement of clinical symptoms and renal function in ADHF patients.


Condition Intervention Phase
Acute Decompensated Heart Failure
Drug: CD-NP
Phase II

Official Title: A Multi-Center, Single-Blind, Placebo-Controlled Phase 2 Study Assessing the Safety and Efficacy of Intravenous CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Nile Therapeutics:

Primary Outcome Measures:
The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion. [ Time Frame: Up to 72 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: June 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Make your considerations ...
Now the price is 0.62

[giasone]

Michael R. Bristow, M.D. Ph.D. Joins Nile Therapeutics Scientific Advisory Board

SAN MATEO, Calif., Oct. 7 /PRNewswire-FirstCall/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, today announced that Michael R. Bristow, M.D. Ph.D. has joined the Scientific Advisory Board overseeing the development of CD-NP, a dual natriuretic peptide receptor agonist in development for the treatment of acute decompensated heart failure.
Dr. Bristow, a recognized leader in the heart failure community, is a Professor of Medicine and the former Head of Cardiology at the University of Colorado Health Sciences Center, where he has been since October 1991. Dr. Bristow was a founder of ARCA biopharma, a biopharmaceutical company developing genetically-targeted therapies for heart failure and other cardiovascular diseases. Dr. Bristow currently serves as Director, President and Chief Executive Officer of ARCA biopharma. Dr. Bristow was the principal founder of Myogen, biopharmaceutical company focused on the discovery, development and commercialization of therapeutics for the treatment of cardiovascular and pulmonary disease. Dr. Bristow served as Myogen's Chief Science and Medical Officer from October 1996 to February 2006 and as a Scientific Advisor to Myogen from February 2006 until the acquisition of Myogen by Gilead Sciences, Inc. in November 2006. Dr. Bristow is also a founder of Miragen Therapeutics, a Boulder, CO based microRNA company.
"We are extremely pleased to welcome Dr. Bristow to our advisory board," said Joshua A. Kazam, Nile's CEO. "We believe that his depth of knowledge in the field of heart failure and his breadth of experience in drug development and commercialization will help us achieve the full potential of CD-NP and our natriuretic peptide program."


NILE IS ON THE MOVE...+ 20% but it's steel very cheap !!!

[giasone]

Good news from Nile AD HF Phase 2 trial...

Nov. 2, 2010, 7:00 a.m. EDT
Nile Therapeutics Phase 2 Study of CD-NP in Patients With Acute Decompensated Heart Failure Meets Primary Endpoint, Has Favorable Trends on Renal Function

SAN MATEO, Calif., Nov. 2, 2010 /PRNewswire via COMTEX/ -- Nile Therapeutics, Inc. (NLTX 0.72, 0.00, 0.00%) , a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, today announced results of its Phase 2 study evaluating its lead compound CD-NP in patients with acute decompensated heart failure (ADHF) and mild to moderate renal insufficiency. Study results demonstrated that multiple doses were characterized as well tolerated with favorable drug activity in this acute patient population.

The open-label, single-blind, placebo-controlled Phase 2 study included 77 patients who were randomized into six cohorts at one of four doses of CD-NP (1.25, 2.5, 3.75 and 5 ng/kg/min) or placebo. Two cohorts were enrolled at each of the 1.25 and 2.5 ng/kg/min dose levels. Patients received study drug for up to 72 hours and were followed for 30 days. The primary objective of the study was to assess the safety and tolerability of CD-NP in a renally compromised ADHF population, the intended population of the therapy. Secondary endpoints included several assessments of drug activity.

CD-NP infusion at 1.25, 2.5 and 3.75 ng/kg/min appeared to be well tolerated. A dose-dependent effect on blood pressure was observed, with minimal or mild blood pressure reduction at 1.25 and 2.5 ng/kg/min, and moderate blood pressure reduction at 3.75 ng/kg/min. Dose escalation was limited by significant blood pressure reduction at 5 ng/kg/min.

Secondary and exploratory analyses demonstrated favorable effects of CD-NP on renal function, particularly at the 1.25 and 2.5 ng/kg/min doses. At these doses, CD-NP appeared to preserve or enhance renal function compared to placebo, as evidenced by favorable trends in several biomarkers correlated with kidney function, including creatinine and cystatin-c.
Data will be presented at an upcoming cardiology conference.

"The data from this trial appear to indicate that we have identified active doses of CD-NP suitable for evaluation in a larger double-blind, placebo controlled study in acute heart failure patients," said James Young, MD, Professor and Dean of Medicine of the Cleveland Clinic and member of Nile Therapeutics Scientific Advisory Board. "Particularly interesting is CD-NP's apparent effect on kidney function, which would be a unique and clinically important benefit over the current standard of care."

"We are excited and encouraged by this data, particularly by the demonstration of activity in the intended patient population, supporting our belief that CD-NP has the potential to be a valuable new therapy for patients with cardiovascular and renal disease," said Joshua Kazam, Chief Executive Officer of Nile Therapeutics. "We look forward to the continued advancement of the CD-NP program."

About Heart Failure

Heart failure is the fastest-growing clinical cardiac disease in the U.S. according to the American Heart Association, affecting over 5 million Americans. Over 1 million patients in the U.S. each year are hospitalized with ADHF, an acute exacerbation of heart failure. This hospitalization rate is almost double the rate seen 15 years ago, and is the most frequent cause of hospital admission in the U.S. for patients older than 65 years, generating annual inpatient costs of more than $33 billion.

[giasone]

Hallo guys !

I need some Answers !!!

Read this...

Why Nile Therapeutics May Succeed Where J&J Failed - Seeking Alpha

NASDAQ:NLTX has the 3rd highest upside potential in this segment of the market. Its upside is 566.7%. Its consensus target price is $4.00 based on the average of all estimates.

For me Nile Therapeutics is really undervalued .

Good Phase II results = possible partnership = possible acquisition

but..

How is real Nasdaq delisting risk for Nile ?

How delisting risk can hurts Nile's stocks price ?


Someone....?!!

[giasone]

No delisting risk until May 31, 2011.

Nile presents phase IIa ADHF results at American College of Cardiology New Orleans April 2 - 5 ,2011

0,63 = Great buy opportunity !!!




Nile Teams With Medtronic for Post-Acute Heart Failure - Seeking Alpha

[giasone]

NILE on the news !!

Nile Therapeutics Receives Fast Track Designation for Cenderitide for Post-Acute Indication -- SAN MATEO, Calif., March 31, 2011 /PRNewswire/ --

Nile Therapeutics Announces Upcoming Data Presentation at the American College of Cardiology Annual Scientific Meeting1 day ago / 6:00San Mateo, Calif.Mar. 30, 2011

SAN MATEO, Calif., March 30, 2011 /PRNewswire/ Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced the schedule of its upcoming cenderitide presentation taking place at the American College of Cardiology (ACC) 60th Scientific Session, April 2-5th.
Location: Ernest N. Morial Convention Center, Hall FDate : Sunday, April 3, 2011Time: 10:00 AM -11:15 AM (CDT)Poster Presentation: Board #256 Presenter: Hsiao D. Lieu, MD, FACCTitle: "A Phase II, Dose-Ranging Study with CD-NP, a Chimeric Natriuretic Peptide, in Acute Decompensated Heart Failure Patients with Renal Compromise"

Don' t miss this great opportunity !!!