Heron Announces Alignment With FDA On Next Steps For HTX-011 NDA Resubmission

(RTTNews) - Heron Therapeutics, Inc. (HRTX) announced a successful Type A meeting with the FDA in which alignment was reached on the plans for the company to resubmit the New Drug Application for HTX-011 for the management of postoperative pain in the fourth quarter of current year. The company plans to resubmit the HTX-011 NDA in the next few months.

"The FDA responded very positively to the information that Heron has generated to resolve the issues contained in the Complete Response Letter and agreed that the proposed specification change was acceptable," said Barry Quart, CEO of Heron.

Shares of Heron Therapeutics were up nearly 9% in pre-market trade on Tuesday.