<SEC-DOCUMENT>0001171843-18-005755.txt : 20180806
<SEC-HEADER>0001171843-18-005755.hdr.sgml : 20180806
<ACCEPTANCE-DATETIME>20180806121033
ACCESSION NUMBER:		0001171843-18-005755
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20180806
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20180806
DATE AS OF CHANGE:		20180806

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			BIOCRYST PHARMACEUTICALS INC
		CENTRAL INDEX KEY:			0000882796
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				621413174
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-23186
		FILM NUMBER:		18994058

	BUSINESS ADDRESS:	
		STREET 1:		4505 EMPEROR BOULEVARD
		STREET 2:		SUITE 200
		CITY:			DURHAM
		STATE:			NC
		ZIP:			27703
		BUSINESS PHONE:		919-859-1302

	MAIL ADDRESS:	
		STREET 1:		4505 EMPEROR BOULEVARD
		STREET 2:		SUITE 200
		CITY:			DURHAM
		STATE:			NC
		ZIP:			27703
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>f8k_080618.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<html><head><title></title></head><body><div style="margin-top: 3pt; margin-bottom: 12pt;"><div style="font-size: 1pt; border-top: Black 2.5pt solid; border-bottom: Black 1.1pt solid; width: 100%;"><font style="font-size: 10pt;">&#160;</font></div></div><p style="text-align: center;"><font style="font-size: 14pt;"><strong>UNITED STATES</strong><br /><strong>SECURITIES AND EXCHANGE COMMISSION</strong><br /><strong>Washington, D.C. 20549</strong><br />_____________________</font></p><p style="text-transform: uppercase; text-align: center;"><font style="font-size: 14pt;"><strong>Form 8-K</strong><br />_____________________</font></p><p style="text-align: center;"><font style="font-size: 12pt;"><strong>CURRENT REPORT</strong></font></p><p style="text-align: center;"><font style="font-size: 12pt;"><strong>Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</strong></font></p><p align="center"><font style="font-size: 10pt;">Date of Report (Date of earliest event Reported): <!--August 6, 2018-->August 6, 2018 &#160;</font></p><p align="center"><font style="font-size: 12pt;"><strong>BioCryst Pharmaceuticals, Inc.</strong></font><br /><font style="font-size: 10pt;">(Exact Name of Registrant as Specified in Charter)</font></p><table style="width: 100%;" border="0" cellspacing="0" cellpadding="0"><tr valign="top"><td align="center" width="33%"><font style="font-size: 10pt;"><strong>Delaware</strong></font></td><td align="center" width="34%"><font style="font-size: 10pt;"><strong>000-23186</strong></font></td><td align="center" width="33%"><font style="font-size: 10pt;"><strong>62-1413174</strong></font></td></tr><tr valign="top"><td align="center" width="33%"><font style="font-size: 10pt;">(State or Other Jurisdiction of Incorporation)</font></td><td align="center" width="34%"><font style="font-size: 10pt;">(Commission File Number)</font></td><td align="center" width="33%"><font style="font-size: 10pt;">(I.R.S. Employer Identification Number)</font></td></tr></table><p><font style="font-size: 10pt;">&#160;</font></p><table style="width: 100%;" border="0" cellspacing="0" cellpadding="0"><tr valign="bottom"><td align="center" width="50%"><font style="font-size: 10pt;"><strong>4505 Emperor Blvd., Suite 200, Durham, North Carolina 27703</strong><!----></font></td></tr><tr valign="top"><td align="center" width="50%"><font style="font-size: 10pt;">(Address of Principal Executive Offices) (Zip Code)</font></td></tr></table><p align="center"><font style="font-size: 10pt;"><strong>(919) 859-1302</strong><br />(Registrant's telephone number, including area code)</font></p><p align="center"><font style="font-size: 10pt;"><strong></strong><br />(Former name or former address, if changed since last report)</font></p><table style="width: 100%;" border="0" cellspacing="0" cellpadding="0"><tr valign="top"><td colspan="3"><font style="font-size: 10pt;">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:<br /><br /></font></td></tr><tr valign="top"><td width="21"><font style="font-size: 10pt;">&#160;</font></td><td width="40"><font style="font-size: 10pt;">[  ]</font></td><td nowrap="nowrap"><font style="font-size: 10pt;">&#160;&#160;Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</font></td></tr><tr valign="top"><td width="21"><font style="font-size: 10pt;">&#160;</font></td><td width="40"><font style="font-size: 10pt;">[  ]</font></td><td nowrap="nowrap"><font style="font-size: 10pt;">&#160;&#160;Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</font></td></tr><tr valign="top"><td width="21"><font style="font-size: 10pt;">&#160;</font></td><td width="40"><font style="font-size: 10pt;">[  ]</font></td><td nowrap="nowrap"><font style="font-size: 10pt;">&#160;&#160;Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</font></td></tr><tr valign="top"><td width="21"><font style="font-size: 10pt;">&#160;</font></td><td width="40"><font style="font-size: 10pt;">[  ]</font></td><td nowrap="nowrap"><font style="font-size: 10pt;">&#160;&#160;Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</font></td></tr></table><p style="font-size: 10pt; margin: 0pt;">&#160;</p><p style="font-size: 10pt; margin: 0pt;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR &sect;230.405) or Rule&#160;12b-2&#160;of the Securities Exchange Act of 1934 (17 CFR&#160;&sect;240.12b-2).&#160;Emerging growth company [&#160;&#160; ]</p><p style="font-size: 10pt; margin: 0pt;">&#160;</p><p style="font-size: 10pt; margin: 0pt;">If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [&#160;&#160; ]</p><div style="margin-top: 12pt; margin-bottom: 3pt;"><div style="font-size: 1pt; border-top: Black 1.1pt solid; border-bottom: Black 2.5pt solid; width: 100%;"><font style="font-size: 10pt;">&#160;</font></div>&#160;</div><hr style="page-break-after: always;" noshade="noshade" /><p><font style="font-size: 10pt;">  <strong>  </strong></font></p><p><font style="font-size: 10pt;"><strong>Item 7.01. Regulation FD Disclosure.</strong></font></p><p><font style="font-size: 10pt;">
 <p style="margin-left:0in; margin-right:0in;"><font style="color:black">On August 6, 2018 the Company announced that it has been granted fast track designation by the U.S. Food and Drug Administration (FDA) for BCX7353 for the prevention of HAE attacks in patients with hereditary angioedema.</font></p>      <p style="margin-left:0in; margin-right:0in;"><font style="color:black">On August 6, 2018, the Company issued a news release announcing the events described in this Item 7.01.&#160; A copy of the news release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.</font></p>      <p style="margin-left:0in; margin-right:0in;"><font style="color:black">The information furnished in this Item 7.01, including Exhibit 99.1, shall not be deemed &#8220;filed&#8221; for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the &#8220;Exchange Act&#8221;), or otherwise subject&#160; to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.</font></p>      <p style="margin-left:0in; margin-right:0in;"><b><font style="color:black">Forward-Looking Statements</font></b></p>      <p style="margin-left:0in; margin-right:0in;"><font style="color:black">This Current Report on Form 8-K contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst&#8217;s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of HAE second generation drug candidates (including ZENITH-1, APeX-2, APeX-S and APeX-J) may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the Company may not advance human clinical trials with product candidates as expected; that the&#160;FDA, EMA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, or may not provide regulatory clearances which may result in delay of planned clinical trials, or may impose a clinical hold with respect to such product candidate, or withhold market approval for product candidates. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst&#8217;s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst&#8217;s projections and forward-looking statements.</font></p> </font></p><p><font style="font-size: 10pt;"><strong>  </strong></font></p><p><font style="font-size: 10pt;"><strong>Item 9.01. Financial Statements and Exhibits.</strong></font></p><p><font style="font-size: 10pt;">
 <p>(d) Exhibits</p> <table style="border-collapse:collapse !important;" style="border-collapse: collapse; "><tr><td style="vertical-align: bottom ; "><font style="font-size:10pt;"><strong><u>Exhibit No.</u></strong></font></td><td style="vertical-align: bottom ; "><font style="font-size:10pt;">&#160;</font></td><td style="vertical-align: bottom ; "><font style="font-size:10pt;"><strong><u>Description</u></strong></font></td></tr><tr><td style="vertical-align: bottom ; "><font style="font-size:10pt;"><font style="font-size:10pt;"><a href="exh_991.htm" rel="nofollow">99.1</a></font></font></td><td style="vertical-align: bottom ; "><font style="font-size:10pt;">&#160;</font></td><td style="vertical-align: bottom ; "><font style="font-size:10pt;"><font style="font-size:10pt;"><a href="exh_991.htm" rel="nofollow">Press Release dated August 6. 2018 &#8220;U.S. FDA Grants Fast Track Designation for BioCryst&#8217;s BCX7353&#8221;</a></font> </font></td></tr></table></font></p><p><font style="font-size: 10pt;"></font></p><p><font style="font-size: 10pt;"></font></p><hr style="page-break-after: always;" noshade="noshade" /><p align="center"><font style="font-size: 10pt;"><strong>SIGNATURE</strong></font></p><p><font style="font-size: 10pt;">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.</font></p><table style="width: 100%;" border="0" cellspacing="0" cellpadding="0"><tr valign="top"><td valign="top" width="49%"><font style="font-size: 10pt;">&#160;</font></td><td style="font-size: 12pt;" colspan="2" valign="top"><font style="font-size: 10pt;"><strong>BioCryst Pharmaceuticals, Inc.</strong></font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;">&#160;</font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;"></font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">Date: August 6, 2018</font></td><td width="2%"><font style="font-size: 10pt;">By:&#160;</font></td><td style="text-decoration: underline;" width="49%"><font style="font-size: 10pt;">/s/ Alane Barnes&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;">Alane Barnes</font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;">Vice President, General Counsel,<br /> and Corporate Secretary</font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;"></font></td></tr></table><p /></body></html>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exh_991.htm
<DESCRIPTION>PRESS RELEASE
<TEXT>
<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"><html lang="en-US"><head><title>EdgarFiling</title><meta content="text/html; charset=windows-1252" ><meta name="GENERATOR" content="MSHTML 8.00.7601.18094" ></head><body bgcolor="#ffffff"><p style="text-align: right;"><strong>EXHIBIT 99.1</strong></p><p style="text-align: center;"><strong>U.S. FDA Grants Fast Track Designation for BioCryst&#8217;s BCX7353</strong></p><p style="text-align: center;" ></p><p>
 <p align="justify">RESEARCH TRIANGLE PARK, N.C., Aug.  06, 2018  (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, today announced that the Company has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for BCX7353 for the prevention of angioedema attacks in patients with hereditary angioedema (HAE).<br ></p>  <p align="justify">Fast Track Designation provides opportunities for frequent interactions with the FDA during development of a product candidate and provides the opportunity for priority review if supported by clinical data at the time of the new drug application (NDA) submission.</p>  <p align="justify">&#8220;Fast Track Designation from the FDA serves as another indicator of the importance of BCX7353 to meet an unmet medical need for HAE patients in the U.S.,&#8221; said Jon P. Stonehouse, President &amp; Chief Executive Officer. &#8220;We remain focused on completing the Phase 3 program and preparing for an NDA filing in the second half of 2019.&#8221;</p>  <p align="justify"><strong>About BCX7353</strong></p>  <p align="justify">Discovered by BioCryst, BCX7353 is a novel, oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema attacks in patients diagnosed with HAE. BCX7353 was generally safe and well tolerated in the Phase 2 APeX-1 clinical trial. BioCryst is currently conducting the Phase 3 APeX-2 clinical trial and the long-term safety APeX-S clinical trial, both evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment to reduce the frequency of attacks in patients with HAE. BioCryst is also conducting the ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2 clinical trial testing an oral liquid formulation of BCX7353 for the acute treatment of angioedema attacks.</p>  <p><strong>About BioCryst Pharmaceuticals </strong></p>  <p align="justify">BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule medicines that address both common and rare conditions. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, galidesivir, a potential treatment for filoviruses, and a preclinical program to develop oral ALK-2 inhibitors for the treatment of fibrodysplasia ossificans progressiva (FOP). RAPIVAB<sup>&#174;</sup> (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.</p>  <p><strong>Forward-Looking Statements </strong></p>  <p align="justify">This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst&#8217;s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of HAE second generation drug candidates (including ZENITH-1, APeX-2, APeX-S, and APeX-J) may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the Company may not advance human clinical trials with product candidates as expected; that the&#160;FDA, EMA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, or may not provide regulatory clearances which may result in delay of planned clinical trials, or may impose a clinical hold with respect to such product candidate, or withhold market approval for product candidates. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst&#8217;s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst&#8217;s projections and forward-looking statements.</p>  <p>BCRXW</p>  <p>CONTACT:&#160;&#160;&#160; Thomas Staab, BioCryst Pharmaceuticals, +1-919-859-7910</p> </p><p ></p></body></html>
</TEXT>
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