UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) May 13, 2015
BioCryst Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 000-23186 | 62-1413174 |
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 4505 Emperor Blvd., Suite 200 Durham, North Carolina | 27703 |
| (Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code: (919) 859-1302
________________________________________________________________________________
(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 8.01. Other Events.
On May 13, 2015, BioCryst Pharmaceuticals, Inc. (the "Company") announced the initiation of a Phase 1 clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally-administered BCX7353 in healthy volunteers. Discovered by BioCryst, BCX7353 is a novel, selective inhibitor of plasma kallikrein in development for prevention of attacks in patients with hereditary angioedema (HAE). BioCryst has successfully completed nonclinical safety studies, as well as in vitro studies in which BCX7353 exhibited potent and selective inhibition of plasma kallikrein. The pharmacokinetic profile of BCX7353 in preclinical studies indicates its potential for once daily dosing.
On May 13, 2015, the Company issued a news release announcing the events described in this Item 8.01. A copy of the news release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.
Forward-Looking Statements
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 BioCryst may not be able to enroll the required number of subjects in the clinical trial for BCX7353, that the BCX7353 trial may not have a favorable outcome or may not be successfully completed; that the Company may not commence additional human clinical trials for BCX7353; that the FDA or similar regulatory agency may refuse to approve subsequent studies, may impose a clinical hold for BCX7353 or other product candidates, or delay approval of clinical studies which may result in a delay of planned clinical studies and increase development costs of a product candidate; that the FDA may withhold market approval for product candidates; that ongoing and future preclinical and clinical development may not have positive results; that such development programs may never result in future product, license or royalty payments being received. 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.
(d) Exhibits
Exhibit No. | Description | |
99.1 | Press Release dated May 13, 2015 entitled "BioCryst Announces Initiation of a Phase 1 Clinical Trial of BCX7353 for the Treatment of Hereditary Angioedema" |
SIGNATURE
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. (Registrant) | ||
| May 13, 2015 (Date) | /s/ ALANE BARNES Alane Barnes Vice President, General Counsel, and Corporate Secretary |
EXHIBIT INDEX
Exhibit No. | Description | |
99.1 | Press Release dated May 13, 2015 entitled "BioCryst Announces Initiation of a Phase 1 Clinical Trial of BCX7353 for the Treatment of Hereditary Angioedema" |