CHTP could be the next 3-4 bagger at the end on this quarter. Recently the stock tanked after dissapointing P3 results for a neurological low-blood-pressure drug. But the company will be releasing new P3 results at the end of this quarter which will be stacked on the good side.
The initial P3 results were excellent in 4 out of 5 categories (dizziness, weakness, fatigue, concentration, and head/neck pain), with the 1 category which wasnt a failure, but didnt show a significant difference from the placebo. The drug failed to discernibly help symptoms of dizziness or lightheadedness, which was the primary focus of the double-blind trial. But with the new study, the trials are being stacked with patients who showed the highest response to the drug. So results should be great.
The point here is that no other drug for this type of low blood pressure comes close to Droxidopa to treating the disease. The FDA put this on the fast track and analysts are expecting the new P3 results to be good.
This drug Droxidopa has been used in Japan for the past 10 years with a high success rate and found to be very safe. CHTP does not own the distribution right in Japan so they have not collected any revenue from this drug . They bought the rights for the US market and will have complete control upon approval. They are also applying for approval in the EU which will bring in even more revenue.
Since this drug has been proven to be safe and effective, getting approval in the US should not be a problem. This is a much needed drug which has been granted "orphan" status by the FDA. There is an estimated $350M/year market in the US for Droxidopa once is becomes available.
Many people are looking at this to be the next HGSI. Analysts have a price target of $9-$14 once the drug passes P3.
These biotechs are very risky, but as I posted, this drug has been proven to work and is completely safe, so getting approval shouldn't be a problem.
"From October 20, 2009:
Wedbush Morgan Analyst
Dr. Moussatos: Right now I've put one of my companies on the Wedbush Best Ideas List, and it's called Chelsea Therapeutics, the ticker is CHTP. I have an outperform rating and $9 fair value, and it's trading between $2 and $3. The reason I have it outperform is they have guided to releasing the data from their first Phase III trial on a drug that treats a certain kind of low blood pressure condition called neurogenic orthostatic hypotension, or NOH. And that data is due at the end of this quarter, and so it's a near-term major catalyst for this company. The way the trial was designed, they enriched for patients who had the highest response to the drug. And also the drug has already been approved in Japan for over 10 years for the same condition. So we know the drug works. I'm pretty comfortable that this Phase III trial is going to be positive. My fair value is $9. I think the stock is going to go to $9-10 by the end of the quarter. So it's pretty big uptick. I'm pretty comfortable that this drug is going to work in this trial. That's my top pick."
I'm very bullish on this, but obviously, nothing is a sure bet. But the way I look at it, the stock dropped from over $7 down to $2 after the disappointing intial P3 results. So right now, I see it as the pps already reflects bad results. So if for some wild chance that they new P3 trials end up missing, there isnt much downside. I'd say the reward far out weighs the risk. But thats just my opinion. Good Luck to all!
Posted by beerlady on :
how soon do you expect the results to be out, and how soon before the fda gives the approval?
Posted by carl67 on :
The new results are expected sometime this quarter. Most likely in December.
As far as the FDA approval goes, I'm not really sure. But if the P3 results are positive, the approval really doesnt mean much. If it passes P3 trials, the stock should make a nice run.
Look at HGSI, still no approval for their Lupus drug, but once the P3 results came back as successful, the stock went from $2.50 up to almost $23.
So the FDA approval doesnt mean much in the near term as far as how the stock will move. Its the P3 results that will drive the stock.
And as posted before, this drug is proven to work and be safe, so if the trials meet the expectations, approval should be a breeze!
Posted by beerlady on :
cool. Thanks
Posted by carl67 on :
Below is info from a PR about the drug and the "Fast Track" designation which applies to the quickness of approval upon submission of results to FDA. "fast Track" submissions typically take 6 months to review after submission. But that isnt what people look for in the near term. They just want to see positive results from the trials.
"About Droxidopa and the Droxidopa Registration Trial in NOH
Currently available in Japan and with 15 years of safety and efficacy data, Droxidopa is the first drug to demonstrate symptomatic improvement of NOH. As an orally active synthetic precursor of norepinephrine, Droxidopa increases the supply of norepinephrine available for delivery to its receptors, effectively targeting the root cause of NOH to improve orthostatic blood pressure and alleviate symptoms of orthostatic hypotension.
The Droxidopa Phase III registration program in NOH includes two double-blind, placebo-controlled studies: Study 301 and Study 302. Study 301was reviewed by the U.S. Food and Drug Administration (FDA) and awarded a Special Protocol Assessment (SPA). An SPA provides a binding agreement that the study design, including trial size, clinical endpoints and/or data analyses is acceptable to support regulatory approval. In addition to the SPA, the FDA has awarded Chelsea Fast Track designation for its pivotal program in NOH. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need and provides the option to file a New Drug Application (NDA) on a rolling basis. This permits the FDA to review the filing as it is received, expediting the review process. "
Posted by drop24 on :
Thanks for posting.
I love playing biotech stocks. Theres such huge upside to these companies if their drugs pass phase III trials.
This particular drug looks like a winner considering its been used for 15 years in Japan. I dont know how it could fail here in the US.
I'll be keeping an eye on this.
Posted by drop24 on :
Looking into this stock some more reveals posative insider and institutional buying. Some big name institutions are buying shares. This continutes to look better the more I look into it.
I noticed all that insider & institution buying over the past several months too.
Just one of many things pointing to Droxidopa being successful.
I'be been adding to my position over the past week and hopefully the stock will stay under $3 for a couple more weeks. I've been able to get all my shares under $3 and I really want to get more.
Posted by carl67 on :
The insiders as well as the analysts and institutions know much more than me. So when I see the big players willing to move money into a company like this, It makes me feel much better about my investment.
Posted by carl67 on :
From TheStreet.com:
"Chelsea Therapeutics has a 23.1 million-share float with a short interest float of 2.9% as of Sept. 10, according to Yahoo! Finance. Nearly 30% of the company's shares are held by insiders and another 42% is held by institutions. "
So 70% of the shares are help between insiders and institutions!!
Posted by carl67 on :
Barron's 13D
31-Oct-09 05:39 pm Josiah T. Austin increased his stake to 8,169,801 shares (24.04%).
The stock is making a nice little move here at mid-day.
Posted by drop24 on :
Stock getting hammered today....looks like there are changes in the trial which makes the stock riskier.