Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of clinical-stage pharmaceutical company Chelsea Therapeutics (UNKNOWN:CHTP.DL)skyrocketed as much as 151% shortly after the opening bell following a positive recommendation from the Food and Drug Administration's advisory panel on the symptomatic neurogenic orthostatic hypotension drug, Northera.
So what: Chelsea Therapeutics said in a press release after the closing bell yesterday that the FDA panel voted 16-1 in favor of recommending Northera for approval. This news comes in stark contrast to fears last Friday about the panel's decision, based on briefing documents that alluded to a complex decision based on Northera's significant short-term effectiveness and iffy long-term effectiveness. Although the FDA isn't required to follow the panel's advice, it does more often than not, giving Northera a better than 50-50 chance at approval at this point.
Now what: I'd be lying if I said that the overwhelming support for Northera didn't shock the heck out of me, especially after all the questions surrounding the longer-term efficacy of the drug designed to abate dizziness in Parkinson's disease patients. The real test here will be whether the FDA will approve Northera given its checkered past and, if approved, if physicians will opt for the medication considering that it only appears to offer a statistically significant, but short-term benefit. Don't get me wrong; this is clearly a win for Chelsea Therapeutics, but I'd also suggest keeping your optimism in check and considering the shaky history and data behind Northera before bidding shares even higher.