<SEC-DOCUMENT>0001299933-15-000773.txt : 20150514
<SEC-HEADER>0001299933-15-000773.hdr.sgml : 20150514
<ACCEPTANCE-DATETIME>20150514141615
ACCESSION NUMBER:		0001299933-15-000773
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20150514
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20150514
DATE AS OF CHANGE:		20150514

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:		15862007

	BUSINESS ADDRESS:	
		STREET 1:		123 SAGINAW DRIVE
		CITY:			REDWOOD CITY
		STATE:			CA
		ZIP:			94063
		BUSINESS PHONE:		6503662626

	MAIL ADDRESS:	
		STREET 1:		123 SAGINAW DRIVE
		STREET 2:		123 SAGINAW DRIVE
		CITY:			REDWOOD CITY
		STATE:			CA
		ZIP:			94063

	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
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<TYPE>8-K
<SEQUENCE>1
<FILENAME>htm_51825.htm
<DESCRIPTION>LIVE FILING
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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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	Pursuant to Section&nbsp;13 or 15(d) of the Securities Exchange Act of 1934
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	Date of Report (Date of Earliest Event Reported):
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	May 14, 2015
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	Heron Therapeutics, Inc.
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	(Exact name of registrant as specified in its charter)
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	Delaware
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	001-33221
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	94-2875566
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_____________________<BR>
	(State or other jurisdiction
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	of incorporation)
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	File Number)
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	Identification No.)
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	123 Saginaw Drive, Redwood City, California
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	94063
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_________________________________<BR>
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	650-366-2626
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	Not Applicable
<BR>______________________________________________<BR>
	Former name or former address, if changed since last report
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	&nbsp;
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Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:</FONT>
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[&nbsp;&nbsp;]&nbsp;&nbsp;Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)<br>
[&nbsp;&nbsp;]&nbsp;&nbsp;Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)<br>
[&nbsp;&nbsp;]&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))<br>
[&nbsp;&nbsp;]&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))<br>
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	Item 8.01 Other Events.
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On May 14, 2015, Heron Therapeutics, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration has accepted the Company&#x2019;s proposal to use the 505(b)(2) development pathway for HTX-019, the Company&#x2019;s proprietary intravenous  formulation of aprepitant for the prevention of chemotherapy induced nausea and vomiting, as described in the press release furnished herewith as Exhibit 99.1.
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	Item 9.01 Financial Statements and Exhibits.
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(d) Exhibits. <br> <br>		<br>Exhibit No.     Description<br>	<br>99.1	  	Press Release, dated May 14, 2015<br>
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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
	undersigned hereunto duly authorized.
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	Heron Therapeutics, Inc.
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	May 14, 2015
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	By:
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<I>
	/s/ Esme C. Smith
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	Name: Esme C. Smith
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	Title: VP, General Counsel & Secretary
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	Exhibit&nbsp;Index
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	99.1
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Press Release dated May 14, 2015
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<P align="center" style="font-size: 10pt"><FONT style="font-size: 14pt">Heron Therapeutics Announces Positive Outcome from Meeting with FDA for HTX-019</FONT>



<P align="left" style="font-size: 14pt"><FONT style="font-size: 12pt">REDWOOD CITY, Calif. &#150; May&nbsp;14, 2015 &#150; Heron Therapeutics, Inc. (NASDAQ: HRTX), announced today
that the U.S. Food and Drug Administration (FDA)&nbsp;has accepted the Company&#146;s proposal to use the
505(b)(2) development pathway for HTX-019, Heron&#146;s proprietary intravenous formulation of
aprepitant for the prevention of chemotherapy induced nausea and vomiting (CINV).
</FONT>

<P align="left" style="font-size: 12pt">A 505(b)(2) application allows a portion of the information required for a New Drug Application
(NDA)&nbsp;approval, such as safety and efficacy data on the active ingredient, to come from previously
completed studies conducted by other parties. This pathway can lead to significantly reduced costs
and time required for development compared with a traditional development path.


<P align="left" style="font-size: 12pt">&#147;We are extremely pleased that the FDA has accepted our proposal to develop and eventually register
HTX-019 using the 505(b)(2) pathway,&#148; commented Barry D. Quart, Pharm.D., Chief Executive Officer
of Heron Therapeutics. &#147;Injectable 5-HT<sub>3 </sub>and NK<sub>1</sub> receptor antagonists are the
backbone of CINV prophylaxis, representing U.S. sales of over 3.6&nbsp;million units annually. With the
potential approval of HTX-019 and 5-HT<sub>3</sub> receptor antagonist SUSTOL<sup>&#174;</sup>, our lead
development candidate for the treatment of CINV, Heron would be the only company able to market
intravenous formulations of both 5-HT<sub>3</sub> and NK<sub>1</sub> receptor antagonists.&#148;


<P align="left" style="font-size: 12pt"><B>About HTX-019 for Chemotherapy Induced Nausea and Vomiting</B>


<P align="left" style="font-size: 12pt">HTX-019 is a proprietary intravenous formulation of aprepitant, a neurokinin-1 (NK<sub>1</sub>)
receptor antagonist for the prevention of CINV. NK<sub>1</sub> receptor antagonists are typically
used in combination with 5-HT<sub>3</sub> receptor antagonists. At present, the only injectable
NK<sub>1</sub> receptor antagonist approved in the U.S. contains polysorbate 80, a surfactant,
which may cause hypersensitivity reactions, infusion site reactions or other adverse reactions in
some patients. Heron&#146;s formulation for HTX-019 does not contain polysorbate 80 and may have a lower
incidence of certain types of adverse reactions than reported with the other commercially available
injectable NK<sub>1</sub> receptor antagonist. Heron intends to file an NDA for HTX-019 using the
505(b)(2) pathway in the second half of 2016.


<P align="left" style="font-size: 12pt"><B>About SUSTOL</B><sup><B>&#174; </B></sup><B>and Chemotherapy Induced Nausea and Vomiting</B>


<P align="left" style="font-size: 12pt">Heron&#146;s lead investigational product candidate, SUSTOL<sup>&#174; </sup>(granisetron injection, extended
release), is being developed for the prevention of both acute- and delayed-onset chemotherapy
induced nausea and vomiting (CINV)&nbsp;following the administration of moderately emetogenic
chemotherapy (MEC)&nbsp;or highly emetogenic chemotherapy (HEC)&nbsp;agents. Affecting 70-80% of patients
undergoing chemotherapy, CINV is one of the most debilitating side effects of such treatments,
often attributed as a leading cause of premature discontinuation of cancer treatment. Injectable
5-hydroxytryptamine type 3 (5-HT<sub>3</sub>) receptor antagonists have been shown to be among the
most effective and preferred treatments for CINV, however, an unmet medical need exists for
patients suffering from CINV during the delayed-onset phase, which typically occurs 1-5&nbsp;days
following administration of chemotherapy agents. For delayed-onset CINV, only one injectable
5-HT<sub>3</sub> receptor antagonist is approved for use following the administration of MEC
agents, and none are approved for use following administration of HEC agents. SUSTOL contains the
5-HT<sub>3</sub> receptor antagonist granisetron, selected due to its broad use by physicians based
on a well-established record of safety and efficacy. SUSTOL is formulated with the Company&#146;s
proprietary Biochronomer<sup>&#174;</sup> drug delivery technology and in clinical trials has been shown
to maintain therapeutic drug levels of granisetron for up to five days with a single subcutaneous
injection.


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


<P align="left" style="font-size: 12pt">HTX-011, which utilizes Heron&#146;s proprietary Biochronomer drug delivery technology, is a long-acting
formulation of the local anesthetic bupivacaine in combination with the anti-inflammatory meloxicam
for the prevention of post-operative pain. The effective management of pain with a reduction in the
use of opioids remains an important area of unmet medical need, and HTX-011 could potentially
provide a differentiated therapeutic profile with advantages compared to currently available pain
management options. In a Phase 1 clinical trial, HTX-011 achieved the desired pharmacokinetic
profile for both bupivacaine and meloxicam. Therapeutically relevant plasma bupivacaine levels were
sustained for 2-3&nbsp;days in the absence of the large initial peak that can be observed with
commercially available formulations. The anesthetic effects of HTX-011 persisted through 96 hours,
which closely correlated with plasma bupivacaine concentrations, and HTX-011 was well-tolerated
with no serious adverse events.


<P align="left" style="font-size: 12pt"><B>About HTX-003 for Chronic Pain and Addiction</B>


<P align="left" style="font-size: 12pt">HTX-003, which utilizes Heron&#146;s proprietary Biochronomer drug delivery technology, is a long-acting
formulation of buprenorphine for the management of chronic pain and opioid addiction. HTX-003 is
designed to maintain therapeutic drug levels of buprenorphine for 30&nbsp;days following a single
subcutaneous injection with a low potential for patient abuse.


<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 biotechnology company using its proprietary technology and innovative
efforts to develop products to address unmet medical needs. The Company&#146;s proprietary Biochronomer
drug delivery technology is designed to improve the therapeutic profile of injectable
pharmaceuticals. The Company&#146;s product development efforts focus on identifying current therapies
with the potential to be reformulated to expand or extend therapeutic effect or duration of action,
minimize drawbacks or to apply new delivery methods. In addition, we continually evaluate potential
development programs, technologies and product candidates that may be complementary to or
synergistic with our existing programs and product development goals.


<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 Therapeutics cautions readers that forward-looking statements
are subject to certain risks and uncertainties that could cause actual results to differ
materially.</FONT><FONT style="font-size: 9pt"> </FONT><FONT style="font-size: 12pt">These risks and uncertainties include those associated with: the Company&#146;s
proposed refiling of its new drug application resubmission for SUSTOL, the potential regulatory
approval of SUSTOL and the timing for such approval, if approved at all; the breadth of the scope
of regulatory approval for SUSTOL, if approved; the progress in research and development of
HTX-019, HTX-011, HTX-003 and our other product candidate programs, including the timing of
preclinical activities and clinical studies; safety and efficacy data from our clinical studies
that may not warrant further development of our product candidates or may not be sufficient to
justify pursuit of commercialization of such product candidates; the launch and acceptance of new
products generally; our financial position and our ability to raise additional capital to fund
operations if necessary or to pursue additional business opportunities; strategic business
alliances we may pursue or the potential acquisition of other products or technologies; and other
risks and uncertainties identified in the Company&#146;s filings with the Securities and Exchange
Commission. We caution investors that forward-looking statements reflect our analysis only on their
stated date. We do not intend to update them except as required by law.
</FONT>

<P align="left" style="font-size: 12pt"><B>Contacts:</B>
<BR>
<B>Investor Relations Contact:</B>
<BR>
Jennifer Capuzelo, Sr. Manager, Investor Relations
<BR>
858-703-6063
<BR>
<U>jcapuzelo@herontx.com</U>


<P align="left" style="font-size: 12pt"><B>Corporate Contact:</B>
<BR>
Barry D. Quart, Pharm D., Chief Executive Officer
<BR>
650-366-2626


<P align="center" style="font-size: 12pt"><I>###</I>




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




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