FDA accepts Heron’s refiled HTX-011 application

The FDA accepts for review Heron Therapeutics’ (NASDAQ:HRTX) resubmitted marketing application seeking approval of HTX-011 for the management of postoperative pain. The agency’s action date is March 26, 2020.

The first application was rejected in May citing the need for additional Chemistry, Manufacturing and Controls (CMC) data and other nonclinical information.

Shares up 6% premarket on light volume.

https://seekingalpha.com/news/3510063-fda-accepts-herons-refiled-htxminus-011-application-shares-6-percent-premarket