Posted by: ctraderd | August 26, 2012

Biotech Plays in September

The biotechnology industry has been heating up lately. There are many PDUFAs scheduled for the month of September. I hope to be in the run-ups and run-downs of several companies in September. Also, I will be looking at just plain volatile  biotechs with a lot of potential. The companies  that I will be looking in this report Progenics Pharmaceuticals, Inc. (PGNX), Ironwood Pharmaceuticals, Inc. (IRWD), Navidea Biopharmaceuticals, Inc. (NAVB), and Cornerstone Therapeutics Inc. (CRTX).

1. Progenics Pharmaceuticals (PGNX):

Progenics Pharmaceuticals (PGNX) is a biopharmaceutical organization that focuses on the development and commercialization of cutting-edge therapeutic products to treat patients with life-threatening or debilitating diseases (Paraphrased from: http://www.progenics.com/about.cfm).

PGNX submitted their NDA on August 30, 2011 for their RELISTOR (methylnaltrexone bromide) injection, which is the first medication that explicitly targets the underlying cause of OIC (opioid-induced constipation) in their adult patients with chronic, non-cancer pain. On April 25, 2012, the FDA extended PGNX’s goal PDUFA date of April 27, 2012 to July 27, 2012, on which the FDA issued a CRL requesting more information. There is no current PDUFA date scheduled for RELISTOR this month.

PGNX is currently trading at around $4.29 with a market cap of $145.35 million. The 52-week range of PGNX is $4.12 to $11.34, losing 49.23% this quarter.

PGNX

2. Ironwood Pharmaceuticals (IRWD):

Ironwood Pharmaceuticals (IRWD) is a biopharmaceutical organization that discovers, develops, and intends to commercialize cutting-edge human medicines for their patients (Paraphrased from: http://www.ironwoodpharma.com/index.php).

On April 23, 2012, the FDA extended IRWD’s PDUFA action date by four months in order to complete its review of Linaclotide, which is a treatment for IBS-C (irritable bowel syndrome with constipation) and also chronic constipation (CC). The new PDUFA date is scheduled on September 9, 2012.

IRWD is currently trading at around $12.50 with a market cap of $1.34 billion. The stock has a 52-week range of $9.97 to $15.92, gaining 5.40% this quarter.

IRWD

3. Navidea Biopharmaceuticals (NAVB):

Navidea Biopharmaceuticals (NAVB) is a biopharmaceutical organization that is focused on the development and commercialization of cutting-edge diagnostic agents. These diagnostic agents are for paints with cancer and Alzheimer’s disease. NAVB’s main goal is to introduce the next generation of precision radiopharmaceutical agents to market so doctors and patients can readily access, and benefit from, cutting-edge diagnostic science (Paraphrased from: http://navidea.com/about-us/).

On April 3, 2012, NAVB announced that the FDA extended their PDUFA date for Lymphoseek, part of the 99m-Tc-Tilmanocept kit, to September 10, 2012 from the initial PDUFA date of June 10, 2012. Lymphoseek is an investigational, proprietary radioactive tracing agent for lymphatic mapping and lymphoscintigraphy.

NAVB is currently trading for around $3.81 with a market cap of $394.36 million. The stock has a 52-week range of $2.05 to $4.77 and has gained 42.16% this quarter.

NAVB

4. Cornerstone Therapeutics (CRTX):

Cornerstone Therapeutics (CRTX) is a specialty pharmaceutical company focused on commercializing products for the hospital, niche respiratory and related markets (Paraphrased from: http://www.crtx.com/about_us/our_strategy.html).

CRTX has an AdComm on September 13, 2012 for their NDA of lixivaptan, a treatment for hypervolemic and euvolemic hyponatremia associated with with heart failure and syndrome of inappropriate antidiuretic (SIADH). The PDUFA for lixivaptan is scheduled on October 29, 2012.

CRTX is currently trading for around $6.98 with a market cap of $184.05 million. CRTX has a 52-week range of $4.45 to $8.15 and has gained 38.49% this quarter.

CRTX

All of these stocks hold a lot promise for spectacular volatility, run-ups and run-downs during the month of September. We shall see what happens!

Disclosure: I do not hold positions in any of these stocks as of August 26, 2012 and do not plan to open any positions in these stocks within the next 48 hours.


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