SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): January 30, 2017
BioCryst Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
|(State or Other Jurisdiction of Incorporation)||(Commission File Number)||(I.R.S. Employer Identification Number)|
|4505 Emperor Blvd., Suite 200, Durham, North Carolina 27703|
|(Address of Principal Executive Offices) (Zip Code)|
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report)
|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:|
| ||[ ]|| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
| ||[ ]|| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
| ||[ ]|| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
| ||[ ]|| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Item 7.01. Regulation FD Disclosure.
On January 30, 2017, BioCryst Pharmaceuticals, Inc. (“BioCryst”) announced that the European Medicines Agency (“EMA”) has accepted the filing of its peramivir Marketing Authorization Application (“MAA”) for treatment of symptoms typical of influenza in adults 18 years and older. Peramivir will be commercialized by Seqirus UK Limited as ALPIVABTM. The acceptance of the MAA begins the review process by the EMA under the centralized licensing procedure for all 28 member states of the European Union, Norway and Iceland.
On January 30, 2017, the Company issued a news release announcing the events described in this Item 7.01. A copy of the news release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.
The information furnished in this Item 7.01 is not deemed “filed” 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.
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’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 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 the EMA may not provide regulatory approval for any use of peramivir or that the approval may be limited. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’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’s projections and forward-looking statements.
Item 9.01. Financial Statements and Exhibits.
Press Release dated January 30, 2017 entitled “BioCryst Announces the Acceptance of Peramivir MAA filing by the European Medicines Agency”
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.
| ||BioCryst Pharmaceuticals, Inc.|
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|Date: January 30, 2017||By: ||/s/ Alane Barnes |
| || ||Alane Barnes|
| || ||Vice President, General Counsel,|
and Corporate Secretary
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|Exhibit No|| ||Description|
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|99.1|| ||Press Release dated January 30, 2017 entitled “BioCryst Announces the Acceptance of Peramivir MAA filing by the European Medicines Agency” |