« Steve Nissen vs. GlaxoSmithKline |
| Unintelligent Design »
May 5, 2010
Intermune: Right Back Down Again
Back in March, Intermune's stock saw a sudden jump on news that an FDA advisory committee treated their drug pirfenidone more positively than expected. But the agency is in no way committed to following these recommendations, and yesterday they turned down the drug, sending Intermune stock right back down into the basement again.
Pirfenidone was, even after the advisory committee, an iffy proposition. It made it through one Phase III trial, but missed its endpoints on another. And even though there's no current treatment for idiopathic pulmonary fibrosis, there's no use in telling people that there is one (and asking their insurance companies to pay for it) if there really isn't. The company isn't saying much, but all indications are the the FDA is concerned about efficacy: they aren't convinced that the drug really works, and will want fresh clinical trial data before reconsidering approval.
Whether Intermune can raise the cash to do that is in doubt. If they can't convince the FDA that they have something worthwhile, they'll likely have trouble persuading investors.
+ TrackBacks (0) | Category: Business and Markets | Regulatory Affairs
POST A COMMENT
- RELATED ENTRIES
- The Last Post
- The GSK Layoffs Continue, By Proxy
- The Move is Nigh
- Another Alzheimer's IPO
- Cutbacks at C&E News
- Sanofi Pays to Get Back Into Oncology
- An Irresponsible Statement About Curing Cancer
- Oliver Sacks on Turning Back to Chemistry