Join        Login             Stock Quote

Three Biotechs On The FDA's December Calendar That Could Pop Before 2013

 December 12, 2012 06:06 PM

Although the holidays are rapidly approaching, can you believe it? the Food and Drug Administration (FDA) has a lot of work left on its calendar before flipping to 2K13. Studies we've recently read suggest that biotechs offer abnormal returns in the three days before and following news from the FDA. Approvals, on average, deliver abnormal returns of almost 20%.

iStock reviewed the FDA's pending calendar for some drug stocks that could put some sugar in your portfolio during the holidays.

Alexza Pharmaceuticals Inc's (ALXA) expects to hear from the FDA for its ADASUVE New Drug Application (NDA) with an indicated Prescription Drug User Fee Act (PDUFA) goal date of December 21, 2012. ADASUVE (Staccato loxapine) is Alexza's lead program, which is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

[Related -Futures Down Ahead Of Service Sector Data; Compugen Ltd. (CGEN) Soars]

According to the NAMI  Blue Ridge Family Alliance:

  • Bipolar disorder affects 2.3 million Americans (1.2 percent of the population)
  • Average length of time from onset of symptoms to diagnosis is 10 years.
  • Bipolar disorder accounts for approximately $7.6 billion in direct healthcare costs in the U.S.
  • Lifetime costs per consumer range from $12,000 for a person with a single manic episode to more than $600,000 for those with multiple episodes.

In October, the FDA's Gastrointestinal Drugs Advisory Committee voted unanimously to recommend approval of NPS Pharmaceuticals, Inc.'s (NPSP) Gattex® (teduglutide) for adults with short bowel syndrome (SBS). The committee's recommendation will be considered by the FDA in its review of the company's New Drug Application (NDA) for Gattex. The Prescription Drug User Fee Act (PDUFA) date for completion of the review is December 30, 2012.

[Related -Futures Down On China Worries; Vanguard Health Systems Inc. (VHSSurge]

Short bowel syndrome is a condition in which nutrients are not properly absorbed (malabsorption) because a large part of the small intestine is missing or has been surgically removed. Approximately 10,000–20,000 people in the United States have short bowel syndrome and occurs in about 2 of 10,000 live births, and 75% of the time it occurs in first-born children. There is no cure for short bowel syndrome and has a high infant mortality rate.

Isis Pharmaceuticals, Inc. (ISIS) could have a one two punch for investors the year ends and the next one begins. ISIS plans to initiate the Phase 2/3 study evaluating ISIS-TTRRx in patients with TTR amyloidosis before the end of the year. TTR amyloidosis is a fatal disease that affects approximately 50,000 patients worldwide.  Patients with familial amyloid polyneuropathy, or FAP, experience TTR build up in their peripheral nerves and experience the loss of motor functions, such as walking.  These patients also experience the accumulation of TTR amyloid in the heart, causing familial amyloid cardiomyopathy (FAC), and in their intestinal tract, which prevents the proper absorption of nutrients, leading to death.

Encyclopedia.com says amyloidosis is a rare disease, about 2,000 new cases a year and has no cure. It affects males and females equally and usually develops after the age of 40. At least 15 types of amyloidosis have been identified. Each one is associated with deposits of a different kind of protein.

Early in 2013, the company hopes to get approval for KYNAMRO following a positive recommendation from the FDA's advisory committee. KYNAMRO is a treatment for patients with homozygous FH, who are at extreme cardiovascular risk and are in need of new therapeutic options.

Medicine Plus describes Familial hypercholesterolemia as a genetic disorder caused by a defect on chromosome 19. The defect makes the body unable to remove low density lipoprotein (LDL, or "bad") cholesterol from the blood. This results in high levels of LDL in the blood. High levels of LDL cholesterol make you more likely to have narrowing of the arteries from atherosclerosis at an early age.

Rightdiagnosis.com reports that 1 per 1 million US people suffer from homozygous familial hypercholesterolemia, or roughly 330 people.

With FDA announcements producing a history of abnormal returns, high-risk, high-reward investors would be wise to pay attention to the agency's calendar. If you would like this sort of story to be a regular  feature, let us know by hitting the contact author link up top.



Post Comment -- Login is required to post message
Alert for new comments:
Your email:
Your Website:

rss feed

Latest Stories

article imageTackling China's Debt Problem: Can Debt-Equity Conversions Help?

China’s high and rising corporate debt problem and how best to address it has received much attention read on...

article imageWill Job Growth Kill The Bear-Market Signal For Stocks?

It’s all about jobs now. Actually, it’s always been about jobs. But the stakes are even higher—perhaps more read on...

article imageAutomating Ourselves To Unemployment

In this current era of central planning, malincentives abound. We raced to frack as fast we could for the read on...

article imageFed: Waiting For June… Or Godot?

The Federal Reserve left interest rates unchanged yesterday, as widely expected. But the possibility of a read on...

Popular Articles

Daily Sector Scan
Partner Center

Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.