New River Pharmaceuticals
saw their shares jump Monday after regulators said their attention-deficit hyperactivity disorder drug was approvable.
Shares of Shire were up 8.7% to $53.70, while New River's shares soared to $38.53, up 47%.
The Food and Drug Administration says the drug is approvable but is contingent on a schedule determination by the U.S. Drug Enforcement Administration, Shire said in a press release late Friday. No additional trials need to be conducted for the drug to be cleared.
The FDA has requested that the drug be assigned the status of a schedule II controlled substance, indicating that the treatment has a high potential for abuse and should be prescribed with certain restrictions.
The two companies and the FDA are still discussing a trade name for the drug, which is currently dubbed NRP104. The drug is on track to go on sale in the first quarter of 2007.