<SEC-DOCUMENT>0001299933-16-001925.txt : 20160115
<SEC-HEADER>0001299933-16-001925.hdr.sgml : 20160115
<ACCEPTANCE-DATETIME>20160115091421
ACCESSION NUMBER:		0001299933-16-001925
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20160115
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20160115
DATE AS OF CHANGE:		20160115

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:		161344206

	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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<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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	January 15, 2016
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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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	of incorporation)
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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
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	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 January 15, 2016, Heron Therapeutics, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration has informed the Company that it has not yet completed its review of the New Drug Application of SUSTOL&#174; (granisetron) Injection, extended release and would not be taking action by the Prescription Drug User Fee Act goal date of January 17, 2016 and anticipates taking action in late February 2016, 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 January 15, 2016<br><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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	January 15, 2016
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	By:
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	/s/ Brian Drazba
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	Name: Brian Drazba
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	Title: Vice President, Finance & Chief Financial Officer
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	Exhibit&nbsp;Index
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	99.1
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Press Release, dated January 15, 2016
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<P align="left" style="font-size: 10pt"><FONT style="font-size: 14pt"><B>EXHIBIT 99.1</B>
</FONT>

<P align="center" style="font-size: 14pt">Heron Therapeutics Notified by FDA That It Will Not Take Action on SUSTOL<sup>&#174;</sup> New Drug<BR>
Application by the PDUFA Date



<P align="left" style="font-size: 14pt"><FONT style="font-size: 12pt">REDWOOD CITY, Calif. &#150; January&nbsp;15, 2016 &#150; Heron Therapeutics, Inc. (NASDAQ: HRTX), announced
today that the U.S. Food and Drug Administration (FDA)&nbsp;has informed the Company that it has not yet
completed its review of the New Drug Application (NDA)&nbsp;of SUSTOL<sup>&#174;</sup> (granisetron)
Injection, extended release and would not be taking action by the Prescription Drug User Fee Act
(PDUFA)&nbsp;goal date of January&nbsp;17, 2016 and anticipates taking action in late February&nbsp;2016.
</FONT>

<P align="left" style="font-size: 12pt">SUSTOL is a long-acting formulation of the FDA-approved 5-hydroxytryptamine type 3
(5-HT<sub>3</sub>) receptor antagonist granisetron being developed for the prevention of both acute
and delayed chemotherapy-induced nausea and vomiting (CINV)&nbsp;associated with moderately emetogenic
chemotherapy (MEC)&nbsp;or highly emetogenic chemotherapy (HEC). SUSTOL is formulated utilizing Heron&#146;s
proprietary Biochronomer<sup>&#174;</sup> drug delivery technology, and has been shown to maintain
therapeutic drug levels of granisetron for at least five days with a single subcutaneous injection.


<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 focused on improving the lives of patients by
developing best-in-class medicines that address major unmet medical 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. Heron&#146;s goal
is to build on therapeutics with well-known pharmacology by improving their tolerability and
efficacy as well as broadening their potential field of use. 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. These risks
and uncertainties include, but are not limited to, those associated with: whether the U.S. Food and
Drug Administration (FDA)&nbsp;completes its review within the anticipated time period, whether the FDA
approves the SUSTOL NDA as submitted or supports as broad of a labeled indication for SUSTOL as
requested, the potential market opportunity for SUSTOL and expected timing of the commercial
launch, the progress in the research and development of HTX-019, HTX-011 and our other programs,
including the timing of preclinical, clinical, and manufacturing activities, safety and efficacy
results from our studies that may not justify the pursuit of further development of our product
candidates, acceptance of SUSTOL and 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 products
or technologies, and our ability to grow our organization to sustain the commercial launch for
SUSTOL, 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>Contacts:</B>
<BR>
<B>Investor Relations Contact:</B>
<BR>
Jennifer Capuzelo, Associate Director, 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


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