November 23, 2012
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 development-stage drug company MAP Pharmaceutical (Nasdaq: MAPP ) jumped as high as 20% today, after its New Drug Application resubmission for Levadex was accepted by the FDA.
So what: The FDA's ruling helps pave the way for Levadex, an orally-inhaled treatment for migraine headaches, and the agency set a goal date of April 15, 2013 under the Prescription Drug User Act. The FDA had rejected an earlier application in March on a number of concerns, though the resubmission successfully addressed those areas. CEO Timothy Nelson called the FDA's acceptance an "important milestone" for the company, and JPMorgan Chase reiterated its overweight rating on MAP, saying it expects Levadex to be approved.
Now what: MAP has no drugs on the market, and Levadex is its most developed, so any steps toward its approval should jolt the share price. According to one estimate, Levadex could bring in $350 million in annual sales by 2016, though MAP would not have sole claim on that income, because Levadex is being marketed in partnership with Allergan (NYSE: AGN ) . With MAP's market cap near $500 million, that contribution should be enough to move the stock higher. Keep an eye the drug maker come April 15 of next year.
Don't miss out on the next MAP update.