Heron Therapeutics' NDA for HTX-011 accepted for Priority Review by FDA

1 January 2019

Heron Therapeutics’ (Nasdaq: HRTX) shares were up 5.85% at $25.14 by late morning on Monday, after the company announced an important development for its drug candidate HTX-011.

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Heron's investigational agent, HTX-011, and has granted it a Priority Review designation.

HTX-011 is a long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. HTX-011 is the first and only dual-action fixed-combination product specifically designed to address both postoperative pain and inflammation in a single administration at the surgical site.

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