<SEC-DOCUMENT>0001299933-17-001079.txt : 20171026
<SEC-HEADER>0001299933-17-001079.hdr.sgml : 20171026
<ACCEPTANCE-DATETIME>20171026084028
ACCESSION NUMBER:		0001299933-17-001079
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20171026
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20171026
DATE AS OF CHANGE:		20171026

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			HERON THERAPEUTICS, INC. /DE/
		CENTRAL INDEX KEY:			0000818033
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				942875566
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33221
		FILM NUMBER:		171154868

	BUSINESS ADDRESS:	
		STREET 1:		4242 CAMPUS POINT COURT, SUITE 200
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92121
		BUSINESS PHONE:		6503662626

	MAIL ADDRESS:	
		STREET 1:		4242 CAMPUS POINT COURT, SUITE 200
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92121

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	AP PHARMA INC /DE/
		DATE OF NAME CHANGE:	20010511

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ADVANCED POLYMER SYSTEMS INC /DE/
		DATE OF NAME CHANGE:	19920703
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
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<TITLE> Heron Therapeutics, Inc. (Form: 8-K) </TITLE>
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		UNITED STATES<BR>
	SECURITIES AND EXCHANGE COMMISSION
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	WASHINGTON, D.C. 20549
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	FORM 8-K
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	CURRENT REPORT
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	October 26, 2017
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	Heron Therapeutics, Inc.
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	Delaware
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	001-33221
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	94-2875566
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	of incorporation)
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	4242 Campus Point Court, Suite 200, San Diego, California
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	92121
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	(858) 251-4400
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	Not Applicable
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167;240.12b-2 of this chapter).</FONT>
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Emerging growth company [&nbsp;&nbsp;]<br>
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	Item 8.01 Other Events.
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On October 26, 2017, Heron Therapeutics, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration has granted Fast Track designation to the Company&#x2019;s investigational agent, HTX-011, for local administration into the surgical site to reduce postoperative pain and the need for opioid analgesics for 72 hours, as described in the press release furnished herewith as Exhibit 99.1.
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(d) Exhibits.<br><br>Exhibit No./ Description<br> 	 <br>99.1 Press Release, dated October 26, 2017<br>
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	99.1
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	&nbsp;
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<A HREF="exhibit1.htm" >
Press Release, dated October 26, 2017
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	SIGNATURES
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	Pursuant to the requirements of the Securities Exchange Act of 1934, the
	registrant has duly caused this report to be signed on its behalf by the
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	Heron Therapeutics, Inc.
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	October 26, 2017
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<TYPE>EX-99.1
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<P align="left" style="font-size: 10pt"><FONT style="font-size: 12pt"><B>EXHIBIT 99.1</B>
</FONT>

<P align="center" style="font-size: 12pt"><B>Heron Therapeutics Granted FDA Fast Track Designation for HTX-011 to Reduce Postoperative Pain and<BR>
the Need for Opioid Analgesics for 72 Hours</B>



<P align="center" style="font-size: 12pt"><I>- First Opioid Alternative for Local Administration Into the Surgical Site<BR>
Granted Fast Track Designation -</I>



<P align="center" style="font-size: 12pt"><I>- Phase 3 Studies for HTX-011 Ongoing;<BR>
NDA Filing Planned for 2018 -</I>



<P align="left" style="font-size: 12pt">SAN DIEGO, Calif.&#151; (BUSINESS WIRE) &#150; October&nbsp;26, 2017&#151; Heron Therapeutics, Inc. (Nasdaq: HRTX)
(the Company or Heron), a commercial-stage biotechnology company focused on developing novel
best-in-class treatments to address some of the most important unmet patient needs, announced today
that the U.S. Food and Drug Administration (FDA)&nbsp;has granted Fast Track designation to the
Company&#146;s investigational agent, HTX-011, for local administration into the surgical site to reduce
postoperative pain and the need for opioid analgesics for 72 hours. Fast Track designation is a
process designed to facilitate the development and expedite the review of new therapies to treat
serious conditions with unmet medical needs by providing sponsors with the opportunity for frequent
interactions with the FDA. Heron recently initiated the HTX-011 Phase 3 program and expects to file
an NDA in 2018.


<P align="left" style="font-size: 12pt">&#147;Fast Track designation of HTX-011 is an important milestone in ongoing efforts to get ahead of the
opioid crisis in America with preventative measures,&#148; said Anita Gupta, D.O., Pharm.D., Senior Vice
President, Medical Strategy and Government Affairs of Heron. &#147;Over-reliance on postoperative
opioids can become the gateway to addiction by exposing opioid na&#239;ve patients to potent and
addictive narcotics and leaving hundreds of millions of leftover pills hiding in our community&#146;s
medicine cabinets. It is encouraging to see the FDA prioritize new options like HTX-011 that can
help minimize or prevent exposure to opioids in the postoperative setting. This will be essential
to stopping addiction before it begins.&#148;


<P align="left" style="font-size: 12pt">HTX-011 is the first and only long-acting, extended-release formulation of the anesthetic
bupivacaine designed to address both postoperative pain and inflammation in a single administration
at the surgical site. HTX-011 leverages meloxicam in our proprietary polymer formulation to
potentiate the local anesthetic activity of bupivacaine over 72 hours. In Phase 2 clinical studies,
HTX-011 has consistently demonstrated superiority over both placebo and bupivacaine, the current
standard-of-care, in all surgical models evaluated and significantly reduced the need for opioids
following surgery. The ongoing Phase 3 studies were designed using the following Phase 2 results
for HTX-011:


<P align="center" style="font-size: 10pt; display: none">1
<!-- PAGEBREAK -->


<P align="left" style="margin-left:4%; font-size: 12pt"><U><B>Bunionectomy</B></U><B>: </B>HTX-011 60 mg reduced pain through 72 hours significantly better than
placebo (p=0.0003) and bupivacaine 50 mg (p=0.0166)


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="6%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">&#149;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>HTX-011 significantly increased the proportion of patients that were
opioid-free through 72 hours after surgery, as compared to placebo (p=0.0106)</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:4%; font-size: 12pt"><U><B>Hernia Repair</B></U><B>: </B>HTX-011 300 mg reduced pain through 72 hours significantly better
than placebo (p=0.0045) and bupivacaine 75 mg (p=0.0427)


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="6%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">&#149;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>HTX-011 significantly increased the proportion of patients that were
opioid-free through 72 hours after surgery, as compared to placebo (p=0.0001) and
bupivacaine 75 mg (p=0.0108)</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">&#147;We are very pleased to receive Fast Track designation for HTX-011 and look forward to working
closely with the FDA to bring this option to patients,&#148; said Barry D. Quart, Pharm.D., Chief
Executive Officer of Heron. &#147;HTX-011 is the first opioid alternative for local administration into
the surgical site to receive Fast Track designation and demonstrates the FDA&#146;s commitment to
addressing the opioid crisis. We expect to report top-line results from our pivotal Phase 3 studies
in the first half of 2018 and then file for FDA review in the second half of 2018. Fast Track
designation may allow us to expedite our commercial launch of HTX-011.&#148;


<P align="left" style="font-size: 12pt"><B>About HTX-011 for Postoperative Pain</B>


<P align="left" style="font-size: 12pt">HTX-011, which utilizes Heron&#146;s proprietary Biochronomer&#174; 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 prevention 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. The Phase 2 development program for HTX-011
was designed to target the many patients undergoing a wide range of surgeries who experience
significant postoperative pain. Heron has recently initiated the HTX-011 Phase 3 program and
expects to file an NDA in 2018.


<P align="left" style="font-size: 12pt"><B>About Heron Therapeutics, Inc.</B>


<P align="left" style="font-size: 12pt">Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives
of patients by developing best-in-class treatments that address some most important unmet patient
needs. Heron is developing novel, patient-focused solutions that apply its innovative science and
technologies to already-approved pharmacological agents for patients suffering from cancer or pain.
For more information, visit <U>www.herontx.com</U>.


<P align="left" style="font-size: 12pt"><B>Forward-Looking Statements</B>


<P align="left" style="font-size: 12pt">This news release contains &#147;forward-looking statements&#148; as defined by the Private Securities
Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on
management&#146;s expectations and assumptions as of the date of this news release and are subject to
certain risks and uncertainties that could cause actual results to differ materially, including,
but not limited to, those associated with: the timing of completion and results of the Phase 3
studies for HTX-011; the timing of the HTX-011 NDA filing and review; the timing of the HTX-011
commercial launch; and other risks and uncertainties identified in the Company&#146;s filings with the
Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their
stated date, and Heron takes no obligation to update or revise these statements except as may be
required by law.


<P align="left" style="font-size: 12pt"><B>Investor Relations and Media Contact:</B>


<P align="left" style="font-size: 12pt">David L. Szekeres
<BR>
Senior VP, General Counsel, Business Development&nbsp;and Corporate Secretary
<BR>
dszekeres@herontx.com
<BR>
858-251-4447


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