Is Transcept Pharmaceuticals (TSPT) new drug application a slam dunk for approval?

6 Apr

About Transcept Pharmaceuticals, Inc.

  • Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience.

 Product pipeline

  • Transcept has two products under development:
    • The main one is Intermezzo® (zolpidem tartrate sublingual tablet) for the treatment of insomnia which has a pdufa date of July 14, 2011

  • For info on Intermezzo, see the Companies website:

  •   the other is TO-2061 for an adjunctive treatment of Obsessive Compulsive Disorder (OCD) which is is Phase II development

Financial Info

 From 10K for year ended 12/31/10; filing on

  • $ 67M cash & marketable securities
  • Total assets $ 74M
  • L-T debt $ 348k
  • Solid cash position, should not need to dilute further via shelf offerings

 From quote summary 4/6/11

  • Market cap $ 120M
  • Average analyst target $12
  • P/E n/a
  • Shares o/s 13.46M, float 5.68M

 Stock data and trading plan


Stock chart looks great, just bought today on the break in trend line and will add on a pullback or a break of $ 9.50.  Here’s the deal, although I am not as excited of the actual drug getting approved due to big time competition in this market, I also think its going to be a slam dunk approval for two reasons:

  1. As stated on the Company website, there was already at a CRL issued against Intermezzo in the past, so this is the second go around for the Company and getting this drug approved.
  2. More importantly, there has already been an approval for the same drug, for the same use, in a spray mist form this year.  See link for official launch:

 Given the above, IMO Intermezzo should be approved and I will most likely hold the stock through approval unless the stock experiences strong momentum before the pdufa date.  My target price is $10-11 pre-pdufa and $12-14 post-pdufa if drug is approved.

 See my other reports under the Biotech Momentum tab and sign up at the bottom to subscribe for e-mail alerts:

Disclosure:  currently long TSPT

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 board. The creator of this board 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 board, all users agree, understand, and acknowledge the creator of the board 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 board 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 board is public information available to anyone! You are responsible for your own trades and not the creator of this board.  Please be aware that investing in securities carries the risk of losing some or all of your money.

2 Responses to “Is Transcept Pharmaceuticals (TSPT) new drug application a slam dunk for approval?”

  1. pokerexpress April 26, 2011 at 2:41 pm #

    Just added today right before the breakout at 9.56. Got a half order filled at 9.46 and I really like the stock chart, although I would like to see a little more volume. All in all though, good action and we have a nice breakout here. Let’s see where this thing can go…

  2. pokerexpress May 9, 2011 at 10:41 am #

    Sold my holdings today for a 6% gain in order to protect against a possible correction in the markets. Will alert if I get back in.

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