FDA calendar crowded with blockbuster decisions for Ironwood, Pfizer and Sanofi

Ironwood's 14-year quest to grow into a full-fledged biotech complete with a commercial product and ambitious development plans is finally coming down to the wire. After posting positive data from a slate of four late-stage studies on the irritable bowel syndrome drug linaclotide, the Cambridge, MA-based developer ($IRWD) now faces an early September PDUFA date with the FDA.

Ironwood CEO Peter Hecht has been set on this course for years, working a partnership with Forest Laboratories ($FRX) and taking the company public--with a considerable amount of help from company insiders--during a trying time for the entire industry. Hecht has been an outspoken champion of the company's future. And he's not about to step back from his bullish stance now that the company is on the verge of a major turning point.

"We're working feverishly to launch this drug," Hecht tells The Boston Globe. "We've got to be able to stock 40,000 pharmacies within a few weeks of launch."

Over the next few weeks the FDA is slated to deliver a series of decisions on key drugs. TheStreet's roundup today includes the linaclotide PDUFA date of September 7, along with Gilead's ($GILD) Aug. 27 date for its HIV combo Quad, Pfizer's ($PFE) unspecified August timetable for tofacitinib for rheumatoid arthritis and Sanofi's ($SNY) closely-watched Aubagio for multiple sclerosis, which is in Genzyme's hands as keeper of the MS franchise.

Ironwood may face one of the biggest game-changing days when it hears back from the FDA, but all of these apps are key for their companies' futures. Pfizer needs to get past the bitter demise of its Alzheimer's drug, while Sanofi has to make a case that its new R&D focus will pay off in major approvals. And like Gilead, the companies enjoy pretty good odds as they go into the final stretch.

- here's the story from the Globe
- and TheStreet's report on the FDA calendar