Nile Therapeutics (Nasdaq: NLTX) has big plans Print E-mail
By Nick DeCesare   
Wednesday, 02 March 2011 08:38
On Tuesday, we alerted our premium subscribers to a small company with a big time product.  Nile Therapeutics (Nasdaq: NLTX) has big plans for its lead product candidate, CD-NP, or cenderitide, for acute decompensated heart failure (ADHF). This morning, the company announced that they had received a positive determination from the NASDAQ Listing Qualifications Panel (the "Panel") indicating that the Panel had granted the Company's request for an extension to remain listed on The NASDAQ Stock Market. 

This followed even more good news issued on Monday, in which the Company announced some positive news and let investors know that they will pursue a new indication for cenderitide (formerly CD-NP) in a new indication, seeking to treat patients with acutely decompensated heart failure who are discharged from the hospital for the first 90 days. 

More importantly, they simultaneously announced they would have all funding for a Phase I trial paid for by medical giant Medtronic (NYSE: MDT).  This trial will investigate what cenderitide can do when delivered through Medtronic’s MiniMed Paradigm Insulin Pump.  Having support and funding from Medtronic speaks volumes about what bigger pharma thinks of Nile’s lead product candidate. 

{tinyThe post-acute market that Nile is targeting is huge, according to Rochard B. Brewer, Nile’s Executive Chairman,  "With over 1 million admissions per year in the U.S., at a cost of over $33 billion, ADHF is one of our country's most expensive health problems.” 

If you recall, in the acute (hospital) setting Nile Therapeutics revealed top line data from their cenderitide Phase IIa study in November. Results were very good, clearly showing benefits of taking a continuous infusion of cenderitide.

The company has confirmed to us that they will be releasing full data at the American College of Cardiology meeting in April 2011.  We are very excited to hear this data and expect a partnership to be revealed in the coming weeks for the Phase IIb trial.  We also expecting that in the coming days, the company will clarify what the focus of that Phase IIb trial will be from their discussions with the FDA.

With the potential for cenderitide in both an acute and post acute setting, Nile Therapeutics is set to sky rocket.  After running up over 30% in the pre-market yesterday, it ended the day up about 7% on the Medtronic and new indication news.  However, we still expecting much bigger news in the days and weeks ahead and some speculators see Nile Therapeutics as a potential 3 or 4 bagger; a target which could increase- depending on the type of deal they can put together in the near future.  It is obvious Big Pharma knows the potential here and how big cenderitide can be for both acute and post acute indications.

We feel it's only a matter of time before Nile Therapeutics' stock prices start to push higher.

Disclosure:  Long NLTX

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