A CRL was received from the FDA regarding the NDA for HTX-011 on April 30, 2019. Heron is conducting The HOPE (Helping Opioid Prescription Elimination) Project evaluating HTX-011 as the foundation of non-opioid multimodal analgesia (MMA). The MarketWatch News Department was not involved in the creation of this content. About Heron Therapeutics, Inc. Heron Therapeutics Receives Complete Response Letter for HTX-011 for the Management of Postoperative Pain - Complete Response Letter Requests Additional Non-Clinical Information - - … In 2019, Heron submitted marketing applications for HTX-011 in the US, European Union, and Canada. Heron resubmitted an NDA to the FDA for HTX-011 in September 2019. Heron submitted an NDA to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018.

An MAA for HTX-011 was validated by the EMA in March 2019 for review under the Centralised Procedure.