Thanksgiving is just a few short weeks away, but a few small drug companies are looking to give thanks for the Food and Drug Administration a little early. They all have PDUFA dates in the next week.
Double dose of pain-free PDUFA?
Cadence Pharmaceuticals
There's a large market for injected pain relievers, which are dominated by opioids that have unwanted side effects. The FDA even signaled as much by giving Acetavance a priority review. With a PDUFA date of the 13th, investors won't have to wait much longer to know if Cadence won its first drug approval.
On the other side of the weekend, NeurogesX
The patch passed two phase 3 clinical trials in PHN patients, so an approval seems fairly likely. With any small biotech, the worry is often in the FDA finding an issue with manufacturing or quality control, which are less visible to investors than results from clinical trials. But that risk is somewhat diminished because the EU signed off on the patch earlier this year.
My bioreactor is bigger than your bioreactor
Orphan drug specialist Genzyme
Easier said than done.
The company had a PDUFA date last November, but the decision was pushed back after the FDA decided that the drug produced at the larger scale wasn't similar enough, and therefore required a different name: Lumizyme. Add in another delay, after a warning letter from the FDA because of problems with its manufacturing plant, and suddenly, a year has gone by.
The PDUFA day for Lumizyme is Saturday, so investors may hear about a decision on Friday. An approval seems likely, but then it seemed likely last year as well. With all the trouble that Genzyme has gotten itself into this year, an approval would go a long way toward getting Genzyme back into investors' good graces.
No guarantee of a decision
The FDA issues PDUFA dates based on the Prescription Drug User Fee Act, but the agency is under no obligation to make sure it hits the target date. Delays -- announced or otherwise -- can and do happen.
Take Xenoport
Trading on these dates might seem like a great way to make a quick buck -- the smash-and-grab version of investing -- but getting in and out quickly depends on a finicky FDA. If you're interested in investing because you think the drug is a good one, my advice is to buy now and don't worry about any delay in a decision. It may seem like the FDA is on a never-ending holiday, but it eventually gives responses to all the applications it accepts.