Shares of Flamel Technologies (FLML +15.7%) pop on a 5x surge in volume representing a tidy 450% gain from the December 2012 low of $2.85. The fuel for the uptrend is the expectation that the FDA will issue a ruling that will favor Flamel's Bloxiverz (neostigmine methysulfate injection).
Neostigmine was first synthesized in 1931, making it eligible for grandfathering when the FDA was established. No company had an approved NDA for the product until Flamel's in July 2013. The regulator typically removes unapproved products within one year after it clears an NDA. Bloxiverz will enjoy a period of exclusivity as a result. Approximately 5M vials of neostigmine are sold in the U.S. each year.