BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) Files An 8-K Regulation FD DisclosureItem 7.01. Regulation FD Disclosure.
On May 1, 2018, BioCryst Pharmaceuticals, Inc. (the “Company”) announced that the European Medicines Agency (“EMA”) has approved peramivir with the brand name of ALPIVAB™, a single intravenous infusion for the treatment of uncomplicated influenza in adults and children from the age of 2 years. The EMA’s approval of ALPIVAB™ under the centralized licensing procedure provides marketing authorization for all 28-member states of the European Union, Norway and Iceland. Previously, peramivir injection (RAPIVAB®, RAPIACTA®, PERAMIFLU®) received approval for commercialization in the United States, Canada, Australia, Japan, Taiwan and Korea.
On May 1, 2018, the Company issued a news release announcing the events described in this Item 7.01. A copy of the news release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
The information furnished in this Item 7.01, including Exhibit 99.1, 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 the Company’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: the commercialization success of Rapivab is uncertain, Rapivab may not be made commercially available in approved regions, and commercialization of Rapivab may not provide significant revenues to the Company. Please refer to the documents the Company files periodically with the Securities and Exchange Commission, specifically the Company’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 the Company’s projections and forward-looking statements.
Item 9.01. Financial Statements and Exhibits.
BIOCRYST PHARMACEUTICALS INC ExhibitEX-99.1 2 exh_991.htm PRESS RELEASE EdgarFilingEXHIBIT 99.1BioCryst Receives European Medicines Agency Approval for ALPIVAB for the Treatment of Influenza RESEARCH TRIANGLE PARK,…To view the full exhibit click
About BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)
BioCryst Pharmaceuticals, Inc. (BioCryst) is a biotechnology company. The Company designs, optimizes and develops small molecule drugs that block enzymes involved in the pathogenesis of diseases. The Company focuses on the treatment of rare diseases. The Company uses X-ray crystallography, computer modeling of molecular structures and chemistry techniques to focus on the three-dimensional molecular structure and active site characteristics of the enzymes that control cellular biology. Its drug candidates include RAPIVAB, RAPIACTA, PERAMIFLU, Avoralstat, BCX7353, other second generation hereditary angioedema (HAE) compounds, BCX4430 and Forodesine. Its product RAPIVAB contains peramivir. Peramivir is an intravenous neuraminidase inhibitor approved in various countries for the treatment of patients with influenza, in the United States as RAPIVAB. RAPIVAB is used for the treatment of acute uncomplicated influenza. Its BCX4430 is a broad-spectrum antiviral (BSAV) research program.