ARTICLE | Company News
Priority Review for KemPharm's pain candidate
February 11, 2016 1:14 AM UTC
KemPharm Inc. (NASDAQ:KMPH) gained $2.16 (21%) to $12.67 on Wednesday after FDA granted Priority Review to an NDA for KP201/APAP for short-term management of acute pain. Its PDUFA date is June 9.
The NDA is KemPharm's first marketing application. The company submitted the application under the 505(b)(2) pathway, allowing it to reference data from previously approved products. ...