Yesterday, the biotech announced that the FDA had approved Linzess, its treatment for irritable bowel syndrome. The PDUFA date for the drug wasn't until Sep. 8. Of course, the FDA took an extra three months to review some additional data it requested; so, perhaps finishing early, especially right before a three-day weekend, shouldn't be all that surprising.
Ironwood and partner Forest Labs
The key for a quick launch is to capture patients who are dissatisfied with current treatments. Ironwood and Forest think there are potentially 10 million patients that fit into that category.
Most patients are taking over-the-counter medications, like Procter & Gamble's
As an example of how the conversion could potentially work, the companies cite AstraZeneca
At a market cap of$1.3 billion, investors don't appear to be expecting a very fast launch. With an approval in hand, Ironwood looks like a fairly low-risk stock at this price, with a potential kicker if Linzess can get out of the gates faster than expected. Be sure to follow these companies by adding them to your free personalized watchlist.