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.
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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.
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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.