Biotech Momentum moved to another site!

Hi, I have been wanting to post this for a while now but have not had a chance.  If you are interested in following and discussing bio tech stocks, please go to the following url at TheLion.com forum (it is called Biotech Breakthrough).  I have created my own forum where I can post my ideas and keep track of what I am doing in the biotech world:

http://www.thelion.com/bin/forum.cgi?tf=biotech_breakthrough

 

Hope to see you there!

 

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Sucampo Pharmaceuticals (SCMP) a good risk/reward play

Sucampo Pharmaceuticals, Inc. (SCMP)

 The following research is based on a potential momentum play based on the Companies PDUFA date for Amitiza of April 26, 2013.  Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused on the discovery, development and commercialization of proprietary drugs based on prostones. Prostones are a class of compounds that occur naturally in the human body as a result of enzymatic catalysis by 15-PGDH of eicosanoids and docosanoids.

 About Amitiza:  from the Companies website: (http://investor.sucampo.com/phoenix.zhtml?c=201197&p=irol-presentations)

• Amitiza has been used for over 6 years with 6 million prescriptions by patients with chronic idiopathic constipation and irritable bowel syndrome with constipation
• Priority review in the US (although FDA extended review by 3 months) with target filing in the UK and Switzerland in Q1 2013 as sNDA for treatment of Opioid-Induced Constipation
• Pregnancy warnings have been removed from labeling
• Good safety data and product efficacy

 Product pipeline

Key catalysts

 

Financial info

From Sep 29, 2012 SEC filing:

• Cash $ 78.6M
• Total assets $ 121.1M
• L-T debt $ 61.2M
• Looks to be in solid cash position; should be able to last through potential approval without further dilution, i.e. stock offering(s)

From quote summary Yahoo! Finance 2/8/13

• Market cap $ 219.6M
• Shares o/s 41.59M, float 13.34M
• P/E n/a
• Average analyst target $ 8.00

Stock data

 

 

While the chart above is not the most impressive chart, the stock has been trending sideways with a slight bias to the upside.  As you can see from the trendline drawn there should be a nice floor for the stock around 5.06-5.08.  What I would like to see is a break at 5.50 on greater than average volume.  Once that happens we could see a run back to the 6.00 area before the PDUFA date.  I think this will start to see increased volume in the next couple of weeks once people roll out of other plays and see the potential in this one.  I think there is a greater than 60% probability that this will be approved based on prior use of the drug, the safety and efficacy.  Coupled with possible European filings there are enough catalysts to create nice potential for a 20-25% gain.  There is a nice risk reward on this with IMO.  Set your stop a little below 5 and look to sell around 6.

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

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

Disclosure:  currently long SCMP

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.

Will BioSante Pharmaceuticals (BPAX) continue to surge upward?

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 14^th 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

• Cash and cash equivalents $51M with a shelf offering out of the way in March 2011 we should see no more dilution of shares
• http://finance.yahoo.com/news/BioSante-Pharmaceuticals-bw-797127719.html?x=0&.v=1
• Total assets $57M

 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.

 

Pain Therapeutics (PTIE) positioned to cash in on the pain market?

About Pain Therapeutics, Inc.

• Pain Therapeutics (PTIE) is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, a unique, abuse-resistant controlled-release oxycodone, the Company has three drug candidates in clinical programs, including a novel radio-labeled monoclonal antibody to treat metastatic melanoma, as well as PTI-202 and PTI-721. Pain Therapeutics is also working on a new treatment for patients with hemophilia.

Product pipeline

• The product we are focusing in on is REMOXY.  REMOXY is an exciting product, that is set to take on the $3B pain killer market for Oxycodone; so Blockbuster potential.  It is a reformulation, but is an abuse deterrent drug and its efficacy is good.  REMOXY comes in gel tab form that when crushed retains its form.  It also does not absorb in alcohol or water like the current drugs on the market do.  This allows for less abuse by addicts.
• History of REMOXY
  • June 2008 filed NDA
  • Aug 2008 was given priority review
  • Nov 2008 panel was in favor
  • Dec 2008 FDA issued a CRL asking for no new trials, no change in formulation, but for stability data
  • Dec 2010 PTIE filed stability data
  • Jan 2011 received acceptance for NDA with PDUFA of6/23/11
• Company will receive $15M upon approval from partner Pfizer (formerly King Pharmaceutical) and a 15% royalty on net sales for the first $1B of REMOXY plus 2 other abuse-resistant pain killers currently in clinical trials, and a 20% royalty on net sales > $1B.  PTIE gets a 10% royalty on international sales.

Financial information

From 10K filed2/3/11

• At12/31/10had approx $ 91M in cash, and CFO expects less than $ 5M in cash expenditures in 2011 (does not include potential 15M milestone if REMOXY is approved)
• Total assets $ 99M

From Yahoo! quote summary4/20/11

• Market cap of $ 377M
• Avg analyst target $12
• P/E n/a
• Shares o/s 43M, float 28.5M

 Stock data and trading plan

 

A great opportunity to buy on the dip here, PTIE is currently oversold and within the 50%-38% retracement zone so it is a screaming buy.  Bought more today and will add if it falls under $ 8.50 but I doubt it will.  I am very excited about playing this and think they will get an approval into this $ 3B market, it is a huge market, and they have a shot at being the first abuse deterrent Oxycodone drug on the market.  Run don’t walk to your broker – buy now and hold until it goes over $10.  Will post a comment if I am holding some through approval.

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

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

Disclosure:  currently long PTIE

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.

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

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

http://finance.yahoo.com/news/Transcept-Pharmaceuticals-prnews-422487675.html?x=0&.v=1

• For info on Intermezzo, see the Companies website:

http://www.transcept.com/content/view/39/95/

•   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:

http://finance.yahoo.com/news/Zolpimist-Oral-Spray-Launched-bw-760115425.html?x=0&.v=1

 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:

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

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.

Can NuPathe, Inc. (PATH) add to its recent gains

About NuPathe, Inc. (PATH)

The following research is based on a potential momentum play based on the Companies PDUFA date for Zelrix of August 29, 2011.  NuPathe Inc is a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system. 

 About Zelrix:  from the Companies website:  (http://www.nupathe.com/cns/migraine-zelrix.php)

• Is a transdermal sumatriptan patch for the treatment of migraine; if approved will be the first patch to treat migraine
• Fast onset and sustained release resulting in less nausea during use than other pain medications
• Migraines affect approximately 28 million people in the U.S ~ could be a large market
• Good safety data (see “Top line results from 12 month study” link below)
• Negatives
  • Unusual delivery system ~ will people wear patch
  • Patch causes rashes and/or skin irritations

 FDA acceptance of NDA filing for Zelrix

http://finance.yahoo.com/news/NuPathe-Announces-FDA-iw-2664699224.html?x=0&.v=1

Top line results from 12 month study for Zelrix

http://finance.yahoo.com/news/NuPathe-Announces-Positive-iw-371046875.html?x=0&.v=1

Product pipeline

 

 Financial info

 From 10K for year ended 12/31/10; filing on 3/18/11

• Cash $ 38.9M
• Total assets $ 43.7M
• L-T debt $ 3.7M
• Looks to be in solid cash position; should be able to last through potential approval without further dilution, i.e. stock offering(s)

From quote summary 3/22/11

• Market cap $ 117M
• Shares o/s 14.55M, float 4.54M
• P/E n/a
• Average analyst target $ 13.70

 Stock data

  

Based on the above chart, I am definitely a buyer right now due to a break above the triangle (bull flag) and a stop loss set a little below 7.  Buy more if it breaks the 9.60 level on high volume.  The only downfall is the lack of pipeline as there are only 2 other products that are not even in Phase I trials yet and the fact that the migraine patch is an unusual delivery system that may not gain traction in the market.  However, the safety data IMO gives PATH a greater chance of approval.  So given the chance of approval, the limited market cap of the company and the cash balance that appears there would be no dilution before PDUFA,  I think this stock has great potential, for a 20-30% gain or more by the PDUFA date.  Target range 9.60-10.40. 

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

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

Disclosure:  currently long PATH

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.

Optimer Pharmaceuticals OPTR is another biotech momentum candidate

Optimer Pharmaceutical is another upcoming biotech with a chance for some momentum due to some upcoming game changing events.  See my research below.  Always do your own due diligence before buying any security and please see my diclaimer at the end of this report.

 Notes on Fidaxomicin

• for treatment of Clostridium Difficile Infection or CDI
• Optimer recently received a priority review PDUFA date of May 30, 2011 for its NDA of Fidaxomicin and an advisory committee on April 5th:

 http://www.optimerpharma.com/news.asp?news_story=145&page_num=&year=2011

 Currently over 700k cases in U.S. per year ~ blockbuster potential

• Optimer plans to market the drug in the U.S. and use 3^rd party outside the U.S.
• According to research by Decision Resources, Fidaximicin will be used by the majority of infectious disease specialists.

 http://www.optimerpharma.com/news.asp?news_story=124&page_num=&year=2010

 Additional product pipeline is as follows:

Another exciting product is Pruvel for the treatment of infectious diarrhea, however the company has voluntarily terminated its research study on this due to higher than expected incidences of mild skin rashes during use.  There is no current timeline given by the Company as to how long it will take to research this skin rash issue.

 Financial info:

     On 2/16, Optimer completed a public offering of 6.9M shares at $11.25 per share, resulting in gross proceeds to Optimer of $77.6M ~ now that this offering is done, we can expect some momentum going into the panel and PDUFA event

     Annual filing expecting on or around March 10, 2011

     Last quarter filing

• Cash and cash equivalents $58M
• No long-term debt
• 9 mo revenue of only $1.3M

 Stock data:

  

The stock price is currently at 11.90.  The market just dropped considerably today possibly starting a small correction.  My price range to buy would be around 11.25-11.50, adding more if it goes below 11.  The year end earnings should not affect the stock too much as there are no revenues.  My target is from $13-14, with further upside after approval of $15-16.

See my other reports on upcoming biotech momentum plays and sign up for e-mail alerts:

SPPI

https://pokerexpress.wordpress.com/2011/02/09/spectrum-pharmaceuticals-sppi-has-room-to-run/

 XNPT

https://pokerexpress.wordpress.com/2011/02/03/xnpt-cleared-for-takeoff/

Disclosure:  currently no position in OPTR

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.