Heron Therapeutics, Inc. (NASDAQ:HRTX) Files An 8-K Other Events
Item 8.01 Other Events.
On May1, 2019, Heron Therapeutics, Inc. (the Company) issued a press release announcing that it had received a Complete Response Letter from the U.S. Food and Drug Administration on April30, 2019 for the Companys New Drug Application for the investigational agent HTX-011, 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 (the Press Release). A copy of the Press Release is filed herewith as Exhibit 99.1 and is incorporated herein by reference.
Item 8.01 Financial Statements and Exhibits.
(d) Exhibits.
| Press Release, dated May1, 2019 |
HERON THERAPEUTICS, INC. /DE/ Exhibit
EX-99.1 2 d739627dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 HERON THERAPEUTICS RECEIVES COMPLETE RESPONSE LETTER FOR HTX-011 FOR THE MANAGEMENT OF POSTOPERATIVE PAIN – Complete Response Letter Requests Additional Chemistry Manufacturing and Controls (CMC) and Non-Clinical Information – – No Clinical Safety or Efficacy Issues Identified,…
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About Heron Therapeutics, Inc. (NASDAQ:HRTX)
Heron Therapeutics, Inc. is a biotechnology company engaged in developing pharmaceutical products for patients suffering from cancer or pain. The Company’s product candidates include SUSTOL, HTX-019 and HTX-011. All of its product candidates utilize science and technology platforms, including its Biochronomer drug delivery technology. The Company’s SUSTOL (granisetron) injection, extended release is being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). HTX-019, which is an intravenous formulation of aprepitant, a neurokinin-1 (NK1) receptor antagonist, is being developed for the prevention of CINV. HTX-011, a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam, is being developed for the prevention of post-operative pain. HTX-011 is in Phase II clinical trials.
