Heron Therapeutics Inc. (HRTX)

[north40000]

https://ih.advfn.com/p.php?pid=nmona&article=77714461

"Item 7.01 Regulation FD Disclosure.
On June 21, 2018, Heron Therapeutics, Inc. (the “Company”) issued a press release announcing positive topline results from its Phase 2b study of HTX-011 in subjects undergoing total knee arthroplasty and breast augmentation, as described in the press release furnished herewith as Exhibit 99.1.

The Company also issued a press release announcing that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to the Company’s investigational agent, HTX-011, for postoperative pain management, as described in the press release furnished herewith as Exhibit 99.2.

A copy of presentation materials describing a Company update, all or a part of which may be used by the Company in investor or scientific presentations from time to time, is furnished as Exhibit 99.3 hereto. The attached materials have also been posted on the Company’s website at www.herontx.com . The Company does not undertake any obligation to update this presentation.



Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.



Exhibit
No. Description
99.1 Press Release, dated June 21, 2018
99.2 Press Release, dated June 21, 2018
99.3 Corporate Presentation, dated June 21, 2018"

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"About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer® drug delivery technology, is an investigational, 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. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine alone in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. In the second half of 2018, Heron expects to submit a New Drug Application (NDA) to the FDA for HTX-011."