<SEC-DOCUMENT>0001171843-16-007106.txt : 20160108
<SEC-HEADER>0001171843-16-007106.hdr.sgml : 20160108
<ACCEPTANCE-DATETIME>20160108073253
ACCESSION NUMBER:		0001171843-16-007106
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20160108
ITEM INFORMATION:		Regulation FD Disclosure
FILED AS OF DATE:		20160108
DATE AS OF CHANGE:		20160108

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:		161331463

	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>
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<TYPE>8-K
<SEQUENCE>1
<FILENAME>gff8k_010816.htm
<DESCRIPTION>FORM 8-K
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>WASHINGTON</B></FONT>,
D.C. 20549</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>FORM 8-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>CURRENT REPORT</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>PURSUANT TO SECTION 13 OR 15(d)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>OF THE SECURITIES EXCHANGE ACT OF 1934</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Date of Report (Date of earliest event
reported): January 8, 2016</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.2in"><B>BioCryst Pharmaceuticals,
Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-weight: normal"><I>(Exact
Name of Registrant as Specified in Charter)</I></FONT></P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 33%; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Delaware</B></FONT></TD>
    <TD STYLE="width: 34%; text-align: center; font-weight: bold"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>000-23186</B></FONT></TD>
    <TD STYLE="width: 33%; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>62-1413174</B></FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><I>(State or Other Jurisdiction</I></FONT></TD>
    <TD STYLE="text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><I>(Commission</I></FONT></TD>
    <TD STYLE="text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><I>(IRS Employer</I></FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><I>of Incorporation)</I></FONT></TD>
    <TD STYLE="text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><I>File Number)</I></FONT></TD>
    <TD STYLE="text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><I>Identification No.)</I></FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>4505 Emperor Blvd., Suite 200<BR>
Durham, North Carolina 27703</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>(Address of Principal Executive Offices)</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(919) 859-1302</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>(Registrant&rsquo;s telephone number,
including area code)</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">________________________________________</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>(Former Name or Former Address, if Changed
Since Last Report)</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">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
(see General Instruction A.2 below):</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">[_]<FONT STYLE="font-size: 10pt">&#9;Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">[_]<FONT STYLE="font-size: 10pt">&#9;Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">[_]<FONT STYLE="font-size: 10pt">&#9;Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17&nbsp;CFR&nbsp;210.14d-2(b))</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">[_]<FONT STYLE="font-size: 10pt">&#9;Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17&nbsp;CFR&nbsp;240.13e-4(c))</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Item&nbsp;7.01. Regulation FD Disclosure.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">BioCryst has previously reported
results from a Phase 1 study of healthy volunteers (NCT02448264). At that time, a total of 34 subjects had received single
doses and 40 subjects had received multiple doses of BCX7353. Subsequently, cohorts of healthy Japanese volunteers were added
to the study to support development of BCX7353 in Japan under the Sakigake accelerated R&amp;D designation. Following
assessment of single oral doses of BCX7353 of 100 mg (6 subjects) and 500 mg (6 subjects), 250 mg of BCX7353 was administered
orally and daily for seven days to ten subjects. Compared to Western subjects administered the same dose level, plasma drug
levels in Japanese subjects were moderately higher. Kallikrein inhibition on day seven of daily dosing with 250 mg in
Japanese subjects was similar to that seen at the 350 mg daily and 500 mg daily dose levels in Western subjects.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">Oral BCX7353 has been generally safe and well
tolerated in a total of 96 Western and Japanese healthy volunteers treated, 46 with single doses and 50 with multiple doses. Dose
levels have included single doses of up to 1000 mg, once-daily doses of up to 500 mg for seven days, and once-daily doses of 350
mg for 14 days. No serious adverse events have been seen and no dose-limiting toxicity has been identified. There have been no
clinically significant laboratory abnormalities, ECG changes, or vital sign changes observed.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">In single dose subjects, 89% (31 of 35) of
adverse events (AEs) have been grade 1. The four grade 2 AEs observed were: nausea (1) and vomiting (1) occurring in one subject;
hay fever (1); and diarrhea (1, from Japanese cohort).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">In multiple dose subjects, 90% (63 of 70)
of adverse events (AEs) have been grade 1. The six grade 2 AEs observed were: upper abdominal pain (1, discontinued from study);
syncope (1); headache (1); diarrhea (1) and upper abdominal pain (1) occurring in one subject (discontinued from study), and maculopapular
rash (1, from Japanese cohort, described below). One grade 3 AE was observed, cutaneous delayed-type hypersensitivity reaction,
described below.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">The incidence of drug-related skin rash across
all multiple-dose cohorts was 4% (2 of 50 subjects). One Japanese subject dosed at 250 mg daily for seven days developed a grade
2 maculopapular skin rash following cessation of dosing, and one previously reported Western subject dosed at 500 mg daily for
seven days developed a grade 3 hypersensitivity reaction, described as a maculopapular skin rash, following cessation of dosing.
Both AEs were assessed by the investigator as drug-related. The Japanese subject received antihistamines and the Western subject
received corticosteroids, and in both cases the rash resolved within a few days.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">In early 2016, BioCryst intends to begin a
proof-of-concept randomized placebo-controlled trial of BCX7353 in hereditary angioedema (HAE) patients, APeX-1, and report results
in mid-2016.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">BioCryst recently initiated dosing of subjects
in OPuS-4, a long-term safety study of avoralstat (BCX4161). OPuS-4 is a single arm, open-label study to evaluate the long-term
safety of avoralstat prophylaxis in HAE subjects who have completed previous studies of avoralstat, and in new subjects for whom
oral prophylaxis is considered appropriate. Eligible subjects will receive the top dose of 500 mg three times a day that is being
evaluated in the OPuS-2 study. Subjects will be eligible to receive study drug for as long as they are deemed to derive clinical
benefit with an acceptable safety profile, or until the product receives regulatory approval. The study will evaluate the long-term
safety and tolerability of avoralstat administered as oral prophylaxis in subjects with HAE, assess HAE attack frequency, severity
and disease activity, and evaluate changes in quality of life during long-term treatment. Further details of the study will be
posted on www.clinicaltrials.gov.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">The information furnished in this Item 7.01
is not deemed &ldquo;filed&rdquo; for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, is not subject
to the liabilities of that section and is not deemed incorporated by reference in any filing under the Securities Act of 1933,
as amended.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B></B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">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.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.2in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: bottom">
    <TD STYLE="text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Dated: January 8, 2016</FONT></TD>
    <TD COLSPAN="2"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>BioCryst Pharmaceuticals, Inc.</B></FONT></TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="text-align: left; width: 50%">&nbsp;</TD>
    <TD STYLE="width: 5%">&nbsp;</TD>
    <TD STYLE="text-align: left; width: 45%"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD><FONT STYLE="font: 10pt Times New Roman, Times, Serif">By: </font></TD>
    <TD STYLE="text-align: left; border-bottom: Black 1pt solid">/s/ Alane Barnes</TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: left">Alane Barnes</TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: left">Vice President, General Counsel, and &#9;Corporate Secretary</TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD></TR>
</TABLE>
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