NuPathe (PATH) is a company I am very impressed with, and I consider it one of the most undervalued companies I have ever seen, even after it made a nice run from $3.40 to $5.10 a share in just 3 trading sessions. As I remarked in my article about Nupathe, my short term target price was $4 a share, so I was also too low on that one. I honestly don't think my article is the main reason it moved so high, but more along the lines of investors not knowing about this little company with such a small market cap and the huge potential it has. Investors and traders just simply see what I see with Nupathe, as they should in my opinion.
Key pipelined drug: NP101
NP101 actively delivers sumatriptan, the most widely prescribed migraine medication. In clinical trials involving more than 10,000 applications, NP101 offered patients fast onset and sustained relief of debilitating migraine symptoms including headache pain and migraine-related nausea (MRN). It utilizes SmartRelief, a proprietary transdermal delivery technology that rapidly transports medication through the skin using a process called iontophoresis.
On Aug 30, 2011, NuPathe announced that it has received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for its migraine patch (NP101 or Zelrix).
In the CRL, the FDA acknowledged that NuPathe established the efficacy of the migraine patch in the overall migraine population. The CRL primarily contained chemistry, manufacturing, and safety questions which the company believes it has, or shortly will have, sufficient data to address. The company may conduct additional clinical and/or non-clinical studies to address these issues.
The CRL is the only real reason the company's stock is not selling for at least 2 times its current price level of around $4.80 a share in my opinion. Efficacy was good, and I believe this is a viable and more efficient treatment for those who suffer from migraines that could be revolutionary in terms of bringing more effective relief and preventive recurrence of migraines. I believe the company has properly addressed the issues the FDA raised in the CRL response, so it is my opinion NP101 will be approved this time around.
The reason for my belief in this is because the company's management has years of experience dealing with The FDA, especially the company CEO. The data looks good in my opinion, and the CRL issues raised by the FDA are definitely fixable.
I hope to be doing a question and answer article with Nupathe CEO Jane H. Hollingsworth soon, so stay tuned for that.
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