Will BioSante Pharmaceuticals (BPAX) continue to surge upward?

1 Jun

About BioSante Pharmaceuticals

BioSante is a specialty pharmaceutical company focused on developing products the treatment of female sexual health and oncology.

 Products

 

Link from company website:

http://www.biosantepharma.com/Products.php

  •  The product I am mainly focusing in on is Bio-T-Gel which is a testosterone gel for the treatment of low testosterone levels in men.  The FDA has accepted the application for the drug and given a PDUFA date of November 14th 2011
    • http://www.reuters.com/article/2011/04/13/us-biosante-idUSTRE73C2RV20110413?feedType=RSS&feedName=globalMarketsNews&rpc=43
    • One negative for the drug is taken right from the companies 10Q is the following:  “Bio-T-Gel was developed initially by BioSante, and then it was licensed to Teva for late stage clinical development.  Teva has filed the Bio-T-Gel NDA and the PDUFA date is November 14, 2011. In April 2011, Abbott Laboratories, a marketer of a testosterone gel for men, filed a complaint against Teva alleging patent infringement with respect to Bio-T-Gel.  In its NDA filing, Teva has asserted that Bio-T-Gel does not infringe any patent listed in the FDA Orange Book related to Abbott’s testosterone gel for men.  Although the outcome of the litigation is uncertain, it could delay the FDA approval and commercial launch of Bio-T-Gel and therefore potentially affect our receipt of royalties based on sales of Bio-T-Gel by Teva.”
    • Another negative is this is the first go round for approval, so there is always the greater possibility of a CRL
  • BioSante is also currently performing a Phase III trial for its lead product LibiGel which is a treatment of female sexual dysfunction under a SPA (special protocol assessment)
  • Other catalysts include 4 cancer vaccines that have all been granted FDA orphan drug status that are still in developmental phase

Financial information

From 10Q filed  5/10/11

 From Yahoo! quote summary6/1/11

  • Market cap $287M
  • Avg analyst target $5.05
  • P/E – N/A
  • Shares o/s 94M, float 83M, short 10.5M

 Stock data and trading plan

  

My plan is to wait for the next dip and trigger the first round of buying between 2.60-2.80 per share, then wait for a break to a new high to add (the high it hits on this leg up).  I will be playing this for a gain of about 10-20% due to the worries about the lawsuit, the fact that this is the first attempt at approval for Bio-T-Gel, the high float of the stock and the anticipation of a summer sideways market.  Of course, if news breaks that the lawsuit has been dismissed then I will play more aggressively.  Also, the fact that the Company has already received financing allows for no more dilution until the PDUFA date.  For now, though the plan is to buy on the dip, hold for a breakout, add, then sell into strength.  GLTA

I would like to hear your comments and also be sure to see my other reports under the Biotech Momentum tab and sign up on the right hand side to subscribe for e-mail alerts:

https://pokerexpress.wordpress.com/category/biotech-momentum/

Disclosure:  currently no position in BPAX

Disclaimer: I have never ever been paid or compensated by anyone for any stock I trade or discuss. None of the information posted on this site is to be construed as financial or investment advice. This information is not to be construed as an offer to buy or sell any security mentioned on this blog. The creator of this blog is not a licensed broker or financial advisor of any kind. The information on this site is gathered from sources available to the public. As consideration in using this blog, all users agree, understand, and acknowledge the creator of the blog is not liable or responsible for the accuracy or use of the information provided on this site and agree to indemnify and hold the creator of this blog harmless from any liability resulting from the accuracy or inaccuracy of the information and from use of the information on this board. All of the information that I post on this blog is public information available to anyone! You are responsible for your own trades and not the creator of this blog.  Please be aware that investing in securities carries the risk of losing some or all of your money.

 

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4 Responses to “Will BioSante Pharmaceuticals (BPAX) continue to surge upward?”

  1. SandyEggoJake June 3, 2011 at 3:47 pm #

    Biotech and horse racing tips? You know, it sort of works!

    We’ve been long $BPAX for over a year…and following the company for several years. As is usual, I’m typically way too early, but we added more in Dec ’10 and April ’11. Our cost basis of less than 50% the value.

    Your plan to buy on a pull back to $2.60-$2.80 is sound. We would add more then too for a trading tranche. But this stock is working very well, and $2.60 might be wishful thinking. Even in the AM bloodbath on the labor data (6/3), it never broke the prior day close.

    But playing for only a 10-20% gain seems modest. If you buy at your low and sell at your low target, you would be out at just $2.86. Even if one uses your high marks, it would seem you would be happy with a sales at $3.36 – just 5% above the high.

    Call us a pig, but we are playing for much more. And not by a price target but by events. The first event we are watching is the Bio-T-Gel PUDFA runup November 14th 2011. We would not be surprised to see the $5 handle by then… the 161% fib from the $3.2 peak. Our tentative strategy then would be to sell out our cost basis plus our trading tranche, and let the rest our core long ride on the lottery ticket… the LibiGel Data/NDA/PUDFA. We feel it will be very difficult for the FDA not to approve LibiGel in this post menopause population, given the SPA, as long at the safety data continues its current trajectory.

    Best of luck catching this train.

    • pokerexpress June 3, 2011 at 10:47 pm #

      Sandy, this stock will definitely come down with the market as it is overbought on virtually no news and the catalyst is still months away. You sound pretty bullish and that is great, however, I am worried about the general market at this stage and that is why I am being conservative. Summer is almost here and unfortunately usually brings low volume and sideways action. Not saying we can’t make money, but I think there is no shame to locking in early profits in the 10-20% range. GLT

  2. pokerexpress June 9, 2011 at 11:05 am #

    Bought the first round today at 2.73. Long BPAX

  3. pokerexpress July 8, 2011 at 11:32 am #

    Sale alert: sold today at 3.39 for a 24% gain. May look to play again on a retracement back down to 3.00-3.10 as long as the selling is on low volume and there is still plenty of time until the PDUFA date.

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